Bedside percutaneous tracheostomy: a prospective randomised comparison of PercuTwist[R] versus Griggs' forceps dilational tracheostomy.
Abstract: Tracheostomy is considered the airway management of choice for patients who require prolonged mechanical ventilation. The development of percutaneous techniques offers many advantages including the ability to perform the procedure in the intensive care unit. The aim of this study was to compare the controlled rotating dilation method (PercuTwist[R]) and the Griggs' forceps dilational tracheostomy.

Patients over 18 years of age undergoing tracheostomy in the intensive care unit were included in the study. They were divided in two random samples - either PercuTwist or forceps dilational tracheostomy. Data collected prospectively included demographic characteristics, procedure duration, blood gas analysis, intracranial pressure, arterial blood pressure and heart rate before and after the procedure. Any complications during or after the procedure due to the tracheostomy were also recorded.

Contrary to the main hypothesis, PercuTwist technique took significantly longer to perform than forceps dilational tracheostomy technique (five minutes [2 to 25] vs three minutes [1 to 17][P=0.006]). A significant increase in [P.sub.a]C[O.sub.2] and decrease in arterial pH were observed in both groups between the pre-tracheostomy and post-tracheostomy blood gas analysis. Haemodynamic tolerance was good. Our results show that intracranial pressure is affected by the procedure whatever the technique used. However we did not observe a decrease in cerebral perfusion pressure. The incidence of complications was 23% (20/87). These complications were minor in 18/20 and were not significantly different between the two groups.

In conclusion, we consider that the PercuTwist technique is safe despite the longer duration of the procedure. Nevertheless the forceps dilational technique remains our routine procedure.

Key Words: intensive care unit, tracheostomy, percutaneous, techniques
Article Type: Report
Subject: Heart beat (Measurement)
Heart beat (Physiological aspects)
Tracheostomy (Methods)
Blood gases (Analysis)
Blood gases (Methods)
Authors: Montcriol, A.
Bordes, J.
Asencio, Y.
Prunet, B.
Lacroix, G.
Meaudre, E.
Pub Date: 03/01/2011
Publication: Name: Anaesthesia and Intensive Care Publisher: Australian Society of Anaesthetists Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2011 Australian Society of Anaesthetists ISSN: 0310-057X
Issue: Date: March, 2011 Source Volume: 39 Source Issue: 2
Geographic: Geographic Scope: France Geographic Code: 4EUFR France
Accession Number: 254014421
Full Text: Tracheostomy is one of the oldest surgical operations and also one of the most commonly performed procedures in critically ill patients. It is considered the airway management of choice for patients who require prolonged mechanical ventilation or prolonged airway protection. There are meaningful advantages which include improvement of patient comfort by reducing oral and laryngeal irritation, facilitation of weaning by reducing respiratory resistance and improving pulmonary cleansing, improvement of patient autonomy and patient communication and lower sedation requirements (1,2). Recent recognition of the benefits of early tracheostomy has promoted its earlier performance (3-6). Furthermore, the development of percutaneous techniques offers many advantages including the ability to perform the procedure in the intensive care unit (ICU). More recent studies and meta-analyses reported very similar procedure duration and complications for surgical tracheostomy performed at the bedside compared with percutaneous techniques (7-10).

Percutaneous techniques are various but the medical literature does not report clear superiority of one to the others3. Recently the controlled rotating dilation method (PercuTwist[R]) was described. It appears to be safe, easy and a quick procedure (11-13). The aim of this study was to compare this method and the Griggs' forceps dilational tracheostomy with regard to operative time, haemodynamic, respiratory and neurological tolerance and incidence of complications.

MATERIALS AND METHODS

Initially, training in the PercuTwist procedure was carried out for six months in our department. The prospective controlled randomised clinical study was then conducted for a 16-month period from September 2006 to January 2008. The study was approved by the local ethics committee, and all patients or their family gave informed consent for a percutaneous tracheostomy. Consecutive patients over 18 years of age undergoing tracheostomy in the ICU were considered for inclusion. The decision to perform a tracheostomy was made according to the 8th Consensus Conference of the French Society of Intensive Care Medicine.

Exclusion criteria were unidentified anatomy of the neck, short neck, cervical spine stiffness or trauma, severe coagulation disorders (international normalised ratio >1.8, partial thromboplastin time >30 seconds, platelet count <50,000 /ml) or severe hypoxaemia ([P.sub.a][O.sub.2]/Fi[O.sub.2] <150). Brain-injured patients showing a low cerebral perfusion pressure (CPP) (<60 mmHg) were also excluded. Low molecular weight heparin was stopped 12 hours before the procedure. Enteral feeding was stopped at least six hours before the procedure. Immediately before the procedure, an independent nurse allocated patients either to the PercuTwist technique (PT) group or to the forceps dilational technique (FDT) group according to a computer generated randomisation list previously prepared by an independent physician of the department. Details of the list were unknown to any of the investigators.

All tracheostomies were performed at the bedside in the ICU and under general intravenous anaesthesia with sufentanil and midazolam. Fifteen minutes before the tracheostomy procedure, all patients received an additional dose of sufentanil (0.5 [micro]g/kg) and a dose of vecuronium (0.15 mg/kg). Patients were ventilated in volume-limited mode (tidal volume of 7 ml/kg), with Fi[O.sub.2]=1. Positive endexpiratory pressure was not changed. No recruitment manoeuvres were performed before or after the procedure. Throughout the procedure, invasive blood pressure, pulse oximetry, end-tidal C[O.sub.2] and electrocardiogram were continuously monitored. Intracranial pressure (ICP) was monitored in head injury patients. Arterial blood gas samples were obtained before tracheostomy and immediately after cannula insertion.

All procedures were performed by two intensive care specialists, who had performed at least 50 tracheostomies of which at least 20 were using the FDT and 20 the PT. One operator was in charge of the bronchoscopic guidance and the airway management and the other was in charge of the tracheostomy. Bronchoscopy was not blinded and the whole procedure (tracheal puncture and progression of the dilator) was visualised by both operators on a screen placed at the patient bedside.

The patient's neck was positioned in slight extension. After oral care, the endotracheal tube was pulled back under bronchoscopic control. Transillumination was used to facilitate the identification of the site of puncture and to identify unexpected larger vessels at the planned location of the cannula insertion. After careful surgical disinfection of the skin, the trachea was punctured in the midline without preceding infiltration of local anaesthetics. The trachea was punctured between the second and the third tracheal rings.

Tracheostomy procedure

PercuTwist procedure

After successful fibreoptic-controlled puncture of the trachea, the J-guidewire was introduced into trachea and moved towards the carina. After removal of the needle, a small vertical skin incision not larger than 10 mm was performed. A hydrophilically coated dilation screw (PercuTwist, Rusch[TM], Kernen, Germany) was then dropped into water to activate the coating. Using the guidewire, the dilator was guided towards the skin incision. Under slight pressure the dilator was turned clockwise until the first threads were advanced into the pretracheal tissues. From that point the instrument was gradually advanced by rotation without pushing, until the tip could be endoscopically identified and then introduced, using Seldinger's technique, twist by twist into the trachea under fibreoptic control. The dilating procedure was stopped when the maximum diameter of the dilator was identified in the trachea. The dilator was twisted back and removed. A lubricated tracheostomy cannula with its introducer was then inserted into the trachea.

Forceps dilational tracheostomy

The Portex[R] Percutaneous Blue Line Ultra[R] Tracheostomy Kit (SIMS Portex[R], Fontenay/Bois, France) was used to perform the FDT. After tracheal puncture, the needle was removed and the guidewire was introduced through the catheter. Predilation was performed with the small kit dilator over the guidewire, by using the Seldinger technique. Then, the forceps were introduced over the guidewire, and the handles of the forceps were opened with the blades in the soft tissue anterior to the trachea. The forceps were inserted into the trachea under fibreoptic control to avoid an injury of the posterior tracheal wall, and the stoma was fully dilated. A tracheal cannula mounted on a plastic trocar was passed over the guidewire into the trachea.

All procedures were terminated by a final bronchoscopy to confirm the correct position of the tracheal cannula and to suction blood and secretions.

Data collection

The primary outcome was the procedure duration.

Secondary outcomes were respiratory, haemodynamic and neurological tolerance and the incidence of complications. Data collected prospectively included demographic characteristics, procedure duration, blood gas analysis, intracranial pressure, arterial blood pressure and heart rate before and after the procedure.

Any complications during or after the procedure due to the tracheostomy were also recorded. Technical difficulties included difficult puncture of the trachea, dilation or cannulation difficulties or accidental removal or kinking of the guidewire. Small amounts of bleeding, even if requiring bronchoscopic suctioning, were considered as minor complications. Other complications classified as minor were puncture of the posterior tracheal wall without emphysema, transient hypoxia (defined as pulse oximetry saturation <90%), loss of airway without hypoxia and technical difficulties without conversion to another technique. Loss of airway was defined as extubation of the trachea by inadvertent removal of the endotracheal tube, or difficulties in reintubating the patient. Major complications included bleeding requiring surgical exploration, pneumothorax, posterior tracheal wall lesion with emphysema, loss of airway with hypoxia and technical difficulties with urgent conversion to another technique.

Sample size

The study was powered to show with 90% power and at a significance level of 0.05 a procedure duration reduction of 25% between the FDT and the PT. Indeed the FDT mean duration was seven minutes in the latest published study of our team and the PT mean duration was 5.4 minutes in another published study13,14. The calculated sample size was 43 patients per group (Power Calculator, UCLA Department of Statistics).

Statistics

The data were tested for normal distribution before applying the tests. Normally distributed values are reported as mean (SD), non-normally distributed values are reported as median (range). The durations were compared using the Mann-Whitney U test. Modifications of the physiological variables before and after the procedures were compared using a non-parametric Wilcoxon test. Complication rates in both two groups were compared using a chisquare test or Fisher's exact test when appropriate. A P value of 0.05 was deemed significant.

RESULTS

Ninety-five patients were considered for inclusion (Figure 1). Five patients did not meet inclusion criteria (two coagulation disorders and three cervical spine traumas). Ninety patients were enrolled. Forty-seven were randomised in the PT group and 43 in the FDT group. Only 87 cases are reported due to inadequate data collection in three cases (two in the PT group and one in the FDT group). Epidemiological data and the primary diagnosis for admission to the ICU are presented in Table 1. There was no significant difference between the groups concerning patient characteristics, Simplified Acute Physiology Score II value, duration of ventilation before tracheostomy and diagnosis for admission.

The operating time was defined as the interval from puncture of the trachea to the connection of the tracheostomy cannula to the ventilator. The median operating time was five minutes (2 to 25) in the PT group vs three minutes (1 to 17) in the FDT group (P=0.006). The duration of the procedure was over 15 minutes in three patients of the PT group and in only one patient of the FDT group (P <0.05).

Pre- and postoperative values for [P.sub.a][O.sub.2], [P.sub.a]C[O.sub.2] and pH were not significantly different between the groups. The level of [P.sub.a][O.sub.2] was not significantly different before and after the tracheostomy, and we even observed a small increase in [P.sub.a][O.sub.2] in the PT group. A significant increase in [P.sub.a]C[O.sub.2] and decrease in arterial pH were observed between the pretracheostomy and post-tracheostomy blood gas analysis in both groups. These results are shown in detail in Table 2.

Pre- and postoperative values for heart rate, systolic blood pressure and diastolic blood pressure were not significantly different between both groups. Heart rate was significantly increased at the end of the procedure in the FDT group. Systolic arterial blood pressure was significantly increased in both groups after the procedure. These results are shown in detail in Table 3.

[FIGURE 1 OMITTED]

Intracranial pressure was monitored in 24 patients of whom 10 had been randomised in the PT group and 14 in the FDT group. Pre- and postoperative values for intracranial pressure or cerebral perfusion pressure were not significantly different in both groups. A significant increase of the ICP was observed in the FDT group but the cerebral perfusion pressure was preserved. These results are shown in detail in Table 4.

Early and late complications are presented in Table 5. There were no deaths due to the tracheostomy. Twenty complications are reported (23% of the procedures); 12 in the PT group and eight in the FDT group (non-significant difference).

A large majority (18/20) were minor complications. Technical difficulties were encountered in five patients of the PT group and in four patients of the FDT group (non-significant). Minor bleeding was observed in one patient in the PT group and in three patients in the FDT group (non-significant). Loss of airway without hypoxia occurred in one patient in the PT group and in one patient in the FDT group (non-significant).

Major complications included loss of airway with hypoxaemia (one patient in the PT group) and major bleeding (one patient in the FDT group). No pneumothorax was observed on postoperative chest radiography. No conversion to another technique was required. No posterior tracheal wall lesion with emphysema was reported.

Late complications were re-cannulation difficulties 10 days after the tracheostomy. All these difficulties (four cases) occurred in the PT group. In two cases re-cannulation was only possible with a cannula of a lesser diameter.

DISCUSSION

Percutaneous tracheostomy techniques are widely used in many ICUs in patients requiring longterm mechanical ventilation, except in France (15-18). Although a number of percutaneous techniques have been introduced in the past two decades, the techniques of Ciaglia and colleagues and Griggs and colleagues are the most evaluated. The PT attempts to attenuate the risks of bleeding or overdilation by using a screw dilator with sharp threads to create the stomal opening. Like other teams, we sought a quick, simple, reliable technique that could be performed by all intensive care specialists. We chose the procedure duration as the primary outcome because we had identified in a previous study that an increased duration had been associated with more hypercapnia and probable increases in ICP (19). Reducing this duration may thus be beneficial.

The two groups were similar in terms of age, gender, diagnosis for admission, severity and duration of intubation before tracheostomy.

Contrary to the main hypothesis, the PT took significantly longer to perform than the FDT. Furthermore, three PT durations were longer than 15 minutes. In one case this difficult procedure was associated with a major complication (loss of airway with hypoxia), fortunately without any consequences for the patient.

Perioperative oxygenation remained stable in the two groups. The increase in [P.sub.a][O.sub.2] in the PT group that we observed has already been reported in two studies (11,20). It is thought to be due to the absence of loss of positive end-expiratory pressure during the dilation and to recruitment manoeuvres associated with the rotational dilation. Hypercapnia is a well-known complication of percutaneous tracheostomy. It has been described with FDT (14,19,21). Nevertheless pH variation remains limited and is quickly corrected by mechanical ventilation after the procedure. It is directly associated with the use of the fibreoptic guidance (19,20). In our view the use of endoscopic guidance adds a high level of security to the procedure, even if it is associated with temporary hypercapnia. Haemodynamic tolerance is good. The variations of heart rate or systolic blood pressure are clinically irrelevant. Few studies have evaluated the effects of percutaneous tracheostomy on ICP and CPP in brain-injured patients (20,22-24). Our results show that ICP is affected by the procedure whatever the technique used. Nevertheless we have not observed a decrease in CPP. The mechanisms of the ICP rise during tracheostomy are probably linked to several factors. The first one is the increase of the [P.sub.a]C[O.sub.2] during the procedure. Other factors that could be involved include the delay between injury and tracheostomy, the level of sedation and the position of the head. General preventive strategies should be implemented in an attempt to avoid secondary brain injury. The appropriate timing for tracheostomy must be carefully considered on the basis of ICP stability in each patient. In the early phase of traumatic brain injury, cerebral compliance is low and the autoregulation often affected. Intensive care specialists have to then evaluate the advantages of an early tracheostomy and the risk of intracranial hypertension. Adequate anaesthetic management is necessary to blunt the intracranial response to percutaneous tracheostomy. Appropriate positioning of the head during tracheostomy facilitating normal cerebral venous outflow should be observed, with the patient's head kept at a 20[degrees] neutral position without any hyperextension. In summary, brief episodes of intracranial hypertension occurred during percutaneous tracheostomy; most of them were probably caused by hypercapnia. Even if an increase of C[O.sub.2] seems unavoidable, specific management of these patients should be organised.

Twenty procedures were complicated (23%). All of these complications have been previously reported and shown to occur in 8 to 40% of cases with the FDT (14,19,21,25,26) and 3 to 34% of cases with the PT (12,13,27-29). Whereas these complications were not significantly different according to the group of randomisation, two trends could be identified. The first one is that the FDT could be associated with more bleeding complications due to the uncontrolled procedure of dilation. Haemostasis seems better with the PT probably due to the tight closure of the stoma with the screw during the dilation procedure. Several authors have reported that any bleeding from the incision stopped when the dilator was rotated into the pretracheal tissues and did not reappear after removal of the screw (11,12). The FDT is considered to be safe in patients with coagulation disorders by many authors30 although there is no general agreement on this issue. The second trend is the cannulation difficulties associated with the PT. We did not observe as Westphal and colleagues that the tracheal cannulation or recannulation was easy with the PT (29). In our view, stoma dilation was more difficult with the PT. Indeed it required more physical strength to achieve complete dilation, which is the reason why cannulation is often difficult and recannulation procedures 10 days later could be complicated.

Technical difficulties were frequent with the two techniques but no conversion to another technique was required. Loss of airway with or without hypoxia occurred in three cases. In each case, this complication was caused by the management of the orotracheal tube, which should be pulled back just in the infraglottic area under fibreoptic guidance and not mobilised during the procedure. Posterior tracheal wall injury, a well recognised complication of percutaneous tracheostomy, was not encountered in this study. This complication seems to be unlikely in these two techniques if performed under fibreoptic guidance. Indeed antegrade screwing of the dilatator induces simultaneous elevation of the anterior tracheal wall during PT. During FDT, the position of the extremities of the forceps is continuously controlled by the bronchoscopist. When the alternative procedures (one step or progressive dilational techniques) are used, the view of the posterior tracheal wall is often obstructed and injuries could then occur.

To our knowledge, only one study compares PT and FDT procedures. In this study, the operating time was shorter with the PT than with the FDT (5.4 [1.2] minutes versus 6.2 [1.4] minutes) (13). Global complication rate was 23%. As in our study the number of bleeding complications was greater in the FDT group than in the PT group (10 versus 2%). No serious complications were reported in the PT group.

This study has several limitations. PT has been compared to our routine technique. Thus complications are naturally lower with the routine technique. However, six months training in PT was performed before the study and all operators had performed at least 20 procedures for each technique. Many studies have shown that the complication rate is halved after 20 consecutive procedures with the same technique for a given operator (19,31,32). A dilation difficulty scale or cannulation difficulty scale could have been used to quantify our feeling of higher difficulty associated with PT. Nevertheless it is a randomised controlled study involving 90 patients.

In conclusion, we consider that PT is safe even if it is associated with a longer procedural duration. However FDT remains our routine procedure because it appears easier, requiring lower physical strength. The complication rate between the two procedures was similar. Furthermore, due to its simplicity and quickness, FDT can be used when urgent conversion from an alternative technique is required.

ACKNOWLEDGEMENT

We thank Drs Fusai and Cohen for their helpful corrections.

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A. MONTCRIOL *, J. BORDES ([daggeE]), Y. ASENCIO ([dagger]), B. PRUNET ([dagger]), G. LACROIX ([dagger]), E. MEAUDRE ([dagger]) Department of Anaesthesia and Intensive Care, Sainte Anne Military Teaching Hospital, Toulon, France

* M.D., Anaesthetist.

([dagger]) M.D., Staff Anaesthesiologist.

Address for correspondence: Dr A. Montcriol, Department of Anaesthesia and Intensive Care Unit, Sainte Anne Military Teaching Hospital, BP20545, 83041 Toulon Cedex 09, France. Email: ambroise.montcriol@free.fr

Accepted for publication on October 1, 2010.
TABLE 1
Epidemiological data and diagnosis on admission

                                 PT (n=45)      FDT (n=42)     P

Epidemiologic data

Age, y                           51 (17)        55 (17)        NS

Gender ratio                     0.7            0.5            NS

SAPS II                          42 (16)        40 (12)        NS

Days on ventilator before        11 (7.4)       9.5 (7.2)      NS
tracheostomy

Diagnosis on admission, n

Cerebral injury                  19             25             NS

Respiratory failure              13             9              NS

Shock                            5              3              NS

Burn                             5              3              NS

Medullary injury                 3              2              NS

PT=PercuTwist[R] technique, FDT=forceps dilational technique,
NS=non-significant, SAPS=Simplified Acute Physiology Score.

TABLE 2
Respiratory tolerance of the percutaneous tracheostomies

                       PT (n=45)        FDT (n=42)       P (PT vs FDT)

[P.sub.a][O.sub.2]
(mmHg)

Before tracheostomy    327 (135)        346 (124)        NS
After tracheostomy     351 (127)        324 (133)        NS

[P.sub.a]C[O.sub.2]
(mmHg)

Before tracheostomy    41 (13) *        40 (7) *         NS
After tracheostomy     55 (15) *        52 (15) *        NS

pH

Before tracheostomy    7.44 (0.06) *    7.43 (0.06) *    NS
After tracheostomy     7.33 (0.08) *    7.34 (0.1) *     NS

PT=PercuTwist[R] technique, FDT=forceps dilational technique,
NS=non-significant. * P <0.05 (before vs after tracheostomy).

TABLE 3
Haemodynamic tolerance of the percutaneous tracheostomies

                       PT (n=45)        FDT (n=42)       P (PT vs FDT)

HR, bpm

Before tracheostomy    87 (20)          82 (20) *        NS
After tracheostomy     94 (20)          92 (19) *        NS

SBP, mmHg

Before tracheostomy    128 (26) *       133 (24) *       NS
After tracheostomy     148 (24) *       150 (25) *       NS

DBP (mmHg)

Before tracheostomy    63 (15)          67 (14)          NS
After tracheostomy     69 (17)          72 (14)          NS

PT=PercuTwist[R] technique, FDT=forceps dilational technique, HR=heart
rate, NS=non-significant, SBP=systolic blood pressure, DBP=diastolic
blood pressure. * P <0.05 (before vs after tracheostomy).

TABLE 4
Neurological tolerance of the percutaneous tracheostomies

                       PT (n=10)        FDT (n=14)       P (PT vs FDT)

ICP, mmHg

Before tracheostomy    19 (9)           17 (6) *         NS
After tracheostomy     32 (15)          30 (14) *        NS

CPP, mmHg

Before tracheostomy    70 (17)          75 (19)          NS
After tracheostomy     70 (23)          77 (26)          NS

PT=PercuTwist[R] technique, FDT=forceps dilational technique,
ICP=intracranial pressure, NS=non-significant, CPP=cerebral perfusion
pressure. * P <0.05 (before vs after tracheostomy).

TABLE 5
Complications of the percutaneous tracheostomies

                                      PT (n=45)   FDT (n=42)   P (PT
                                                               vs FDT)

Total                                 12          8            NS

Early   Technical difficulties        5           4            NS
          Bleeding
          Minor                       1           2            NS
          Major                       --          1            NS

        Loss of the airway
          Without hypoxia             1           1            NS
          With hypoxia                1           --           NS

Late    Re-cannulation difficulties   4           0            NS

PT=PercuTwist[R] technique, FDT=forceps dilational technique, NS=non-
significant.
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