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Locally developed guidelines reduce immediate complications from percutaneous dilatational tracheostomy using the Ciaglia Blue Rhino technique: a report on 200 procedures.

SUMMARY

Ciaglia Blue Rhino percutaneous dilatational tracheostomy is used as an aid to ventilatory weaning. It caries an immediate complication rate previously reported in 100 consecutive patients by Fikkers et al at 6% for "major" complications and 30% for "minor" complications. Mortality has been associated with the procedure. Our institution has performed dilatational percutaneous tracheostomy since 1998 and used the Blue Rhino technique since 2002. Consensus guidelines were developed following initial experiences. They focus on preoperative risk assessment including levels of ventilatory support and anatomical considerations, seniority of staff, use of bronchoscopy and capnography and correction of coagulopathies. Following introduction of the guidelines we conducted an audit of the first 200 Ciaglia Blue Rhino tracheostomies performed. There was an immediate major complication rate of 3% and minor complication rate of 18%. No deaths occurred within 24 hours of the procedure. We conclude that applying our consensus guidelines produced an immediate complication rate for Ciaglia Blue Rhino percutaneous dilatational tracheostomy below published audits.

Key Words: bronchoscope, coagulopathy, complication, percutaneous tracheostomy

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Ciaglia first described percutaneous, dilatational tracheostomy in 1985 using multiple, sequential dilators (1). Such procedures are now regularly performed as an adjunct to ventilatory weaning (2). An associated reduced length of stay in intensive care has been noted (3). In the U.K. the Trac-man study is currently aimed at clarifying issues such as the timing and effectiveness of the procedure with respect to weaning (4,5).

In our institution prior to February 2002 we used either Ciaglia's modification of the multiple dilator technique (1) supplied by Cook (88 occasions) or the Griggs method (6), a Seldinger--based single dilatation technique (eight occasions) supplied by Sims Portex, U.K. Three deaths occurred within this group of patients. Two were directly attributable to the perioperative procedure and measures were taken to learn from these experiences (7). Aside from this, limited data existed with respect to immediate complications. A database in Microsoft Excel format was therefore developed in conjunction with consensus guidelines focussing on indications for tracheostomy e.g. failure to wean, failed trial of extubation, preparation, absolute and relative contraindications, management of patients with coagulopathies and performance of the procedure itself (Figure 1). With respect to data it included admission diagnosis, duration of intubation, operator/assistant names, immediate complications plus their nature and the need (if any) for subsequent intervention, e.g. surgery.

Since February 2002 all percutaneous tracheostomies performed in our unit have been via the Blue Rhino technique previously described as being safe (8,9) with a low complication rate relative to surgical tracheostomys (10-13). Complications have previously been described as "early" and "late" with early/immediate complications being classified as minor and major (Table 1) by Fikkers et al (14). The same study reported a minor complication rate of 30% and major complication rate of 6%. Our basic technique (including bronchoscopic visualization) is the same as described by Fikkers. Thus if other groups are to similarly describe their own complication rates for risk management purposes audit is essential (15,16). The introduction of the Ciaglia Blue Rhino technique within our institution in February 2002 was therefore used as an opportunity to audit immediate complications in the light of consensus guidelines.
Figure 1: Local guidelines for percutaneous tracheostomy.

Indications and preparation for tracheostomy

* Failure to wean from mechanical ventilation.

* Failed trial of extubation.

* Consultant(s) and/or a Senior Trainee in
Intensive Care Medicine have performed a risk
benefit assessment of the procedure for an
individual patient.

* Documented consent (when possible) is
obtained from the patient. If impossible the
next of kin is informed of the procedure and
its purpose. Documentary evidence of such
discussions is filed in patients' case notes.

Absolute contra-indications

* Coagulopathy with active bleeding.

* Patient refusal.
Relative contra-indications

* Fi[O.sub.2] greater than 0.6.

* PEEP dependency greater than 10 cm[H.sub.2]O.

* Anatomical anomalies: short neck, previous
surgery, large goitre.

Coagulopathies

* Platelet transfusion for platelet count less than
40 x [10.sup.9]1.

* Fresh frozen plasma for a prolonged prothrombin
time (> 16s).

* Intravenous anti-coagulant therapies are
stopped for a minimum of four hours prior to
tracheostomy.

* Consider delaying procedure if less than 12
hours since the administration of low molecular
weight heparin.

The procedure

* Strict asepsis and subcutaneous infiltration
of the operation site with 1% lignocaine and
adrenaline (for local vasoconstriction).

* Direct bronchoscopic vision with the operator
ideally being a Consultant or Advanced (Step
2) Trainee in Intensive Care Medicine where
possible.

* Usually a "three-person" technique i.e. operator,
bronchoscopist and anaesthetist manipulating
the endotracheal tube.

* A "two-person" technique involves a Consultant
in ICM and a senior Anaesthetic/ICM trainee
as a minimum.


MATERIALS AND METHODS

The aims of the audit were to analyse the immediate minor and major complication rates from the first 200 cases of Ciaglia Blue Rhino percutaneous dilatational tracheostomy in our critical care unit and subsequently compare them to results described by Fikkers et al (14). The audit was performed between February 2002 and November 2005. Data was collected from the unit's percutaneous tracheostomy database held in Microsoft Excel format.

RESULTS

Patients' ages ranged from 19 to 96 years (median age 69 years). The median duration of intubation prior to tracheostomy was 7 days (range 1-22 days) with 29 patients undergoing the procedure following a failed trial of extubation. Six patients (3%) had major complications (two had additional minor complications) and 35 patients (18%) suffered minor complications, three of these patients having two simultaneous minor complications (Table 2). The number of people involved in performing the procedure was recorded on 196 occasions: 96 tracheostomies via a "three-person technique" and 100 via a "two-person" technique. The "three-person" technique when recorded was associated with complications in 19 patients. The "two-person" technique was associated with complications in 21 patients and always involved as a minimum a consultant and senior trainee. No deaths occurred within 24 hours of the procedure and no data was recorded in relation to patients referred to otolaryngology for surgical tracheostomy.

Patients with coagulopathies

Fourteen patients (Table 3) had coagulopathies (platelet count <40x[10.sup.9]1, prothrombin time (PT) >16s, von Willebrand's disease). One patient (liver transplant for acute fulminant hepatic failure) with a platelet count of 37X1011 suffered a venous bleed, which was controlled by pressure. This patient had not received a platelet transfusion. No other immediate complications occurred in the "coagulopathic" group.

DISCUSSION

The audit's aim was to determine the immediate complication rate of percutaneous tracheostomy using the Blue Rhino technique on our unit and compare it to previous results of 6% major complications and 30% minor complications (14). Our complication rate was lower (3% and 18% respectively). Reasons for this are unclear but preoperative risk assessment by two senior critical care physicians in terms of neck anatomy and coagulopathic contraindications, in addition to routine use of bronchoscopic guidance during the procedure are likely to have contributed.

Guidelines were developed locally through consensus discussion amongst senior medical staff. Sources of information include previously published work relating to percutaneous dilatational tracheostomy (15-19). Recommendations associated with coagulopathic patients were developed from haematological advice, associated experiences of surgery in coagulopathic patients and previous episodes of morbidity and mortality from percutaneous tracheostomy (7,20-22). Minimal guidance currently exists for this, although the procedure has been described in thrombocytopenic patients (21) and Kost has previously noted no association between coagulopathies and complication rates (23).

These results, albeit from a small sub-group (n=13) would thus support the evidence of Kost in that only one patient with a bleeding diathesis suffered a perioperative complication. This patient had a platelet count of 37x[10.sup.9]1 and had not undergone a platelet transfusion, a departure from our usual practice. Whether this is relevant remains unclear. Further data is necessary to determine the validity of these findings but the technique appears safe in such sub-groups providing precautions are taken, i.e. adequate risk-benefit assessment and transfusion of appropriate blood products. This information is of particular value in units such as ours that frequently deal with patients in liver failure.

The "two-person" technique did not appear to affect the complication rate. It is difficult to comment any further as data collection in this aspect of the audit was incomplete. Our audit also had other limitations. The guidelines were developed through consensus and are therefore arguably subjective rather than a consequence of Level-1 evidence. Similarly complications such as "difficult tube placement" may also be subjective on the part of the operator. Additionally no data were collected for long-term follow up in order to gauge the incidence of late complications. Such issues have been cited previously in the U.K. (22) and up to 27% of survivors may have voice changes, with 10% having persistent respiratory problems after decannulation (24). One patient in the cohort is known to have required otolaryngological surgery for tracheal stenosis, although the actual aetiology (tracheostomyversus prolonged oro-tracheal intubation) is uncertain. The lower complication rate may also be due in part to relative conservatism and desire to minimize complications in light of other results (14) available from November 2002 onwards, i.e. the procedure may have either been inappropriately avoided if patients had potential difficult neck anatomy or alternatively such patients referred to otolaryngology. It is unclear from our data as to whether or not such referrals occurred and whether other critical care patients would have benefited from the procedure. As more evidence emerges on the appropriateness of percutaneous tracheostomy from the Trac-man trial (4), patient selection may improve and associated auditing and comparison of complication rates become more accurate. At the time of writing our unit is not participating in the trial.

To conclude, in our intensive care unit percutaneous tracheostomy using the Blue Rhino technique has a lower immediate complication rate relative to previous documented audits (14). Use of consensus guidelines may have contributed to this, i.e. preoperative risk assessment by senior clinicians, mandatory use of a bronchoscope, correcting coagulopathies and possibly a "three-person" technique. The latter may have significant manpower issues and is not necessarily standard practice (16, 22). Appropriate timing of tracheostomy also remains uncertain. This may be clarified with the Trac-Man trial (4). Further potential improvements in care include the use of ultrasound in locating subcutaneous vasculature (25-27) and capnography (previously shown to be as effective as bronchoscopy for confirming tracheal cannulation (28)) although its role in confirming exact tube position remains unclear (29,30).

The complication rates from the first 100 cases of this audit were presented at the Annual Scientific meeting of the Australian and New Zealand Intensive Care Society, Adelaide, Australia, October 2005.

Accepted for publication on August 10, 2006.

REFERENCES

(1.) Ciaglia P, Frisching R, Syniec C. Elective percutaneous dilatational tracheostomy, a new simple bedside procedure: preliminary report. Chest 1985; 87:715-719.

(2.) Krishnan K, Elliot SC, Mallick A. The current practice of tracheostomy in the United Kingdom: a postal survey. Anaesthesia 2005; 60:360-364.

(3.) Griffiths J Barber VS, Morgan L, Young JD. Systematic review and meta-analysis of studies of the timing of tracheostomy in adult patients undergoing artificial ventilation. BMJ 2005; 330:1243-1247.

(4.) The Trac-Man study http://www.tracman.org.uk.

(5.) Anonymous. Research and development update, Trac-Man: Tracheostomy management in critical care. Journal of the Intensive Care Society 2005; 6:5.

(6.) Griggs WM, Worthley LIG, Gilligan JE, Thomas PD, Myburgh JA. A simple percutaneous tracheostomy technique. Surg Gyn Obst 1990; 170:543-545.

(7.) Ryan DW, Kilner AJ. Another death after percutaneous dilatational tracheostomy. BJA 2003; 91:925-926.

(8.) Fikkers BG, Staatsen M, Lardenoije SGGF, van der Hoogen FJA et al. Comparison of two percutaneous tracheostomy techniques, guide wire dilating forceps and Ciaglia Blue Rhino: a sequential cohort study. Critical Care 2004; 8:R299-305.

(9.) Fikkers BG, van Heerbeek N, Krabbe PF, Marres HA et al. Percutaneous tracheostomy with guide wire dilating forceps technique: presentation of 171 consecutive patients. Head Neck 2002; 24:625-631.

(10.) Dulguerov P, Gysin C, Perneger TV, Chevrolet JC. Percutaneous or surgical tracheostomy: a meta-analysis. Crit Care Med 1999; 27:1617-1625.

(11.) Freeman BD, Isabella K, Lin N, Buchman TG. A meta-analysis of prospective trials comparing percutaneous and surgical tracheostomy in critically ill patients. Chest 2000; 118:14121418.

(12.) Cheng E, Fee WE Jr. Dilatational versus standard tracheostomy: a meta-analysis. Ann Otol Rhinol Laryngol 2000; 109:803807.

(13.) Baccheta MD, Girardi LN, Southard EJ et al. Comparison of open versus bedside percutaneous dilatational tracheostomy in the cardiothoracic surgical patient: outcomes and financial analysis. Ann Thorac Surg 2005; 79:1879-1885.

(14.) Fikkers BG, Briede IS, Vewiel JMM, van den Hoogen FJ. Percutaneous tracheostomy with the Blue Rhino[TM] technique: presentation of 100 consecutive patients. Anaesthesia 2002; 57:1094-1097.

(15.) Risk Management. The Royal College of Anaesthetists, January 1998.

(16.) Clinical audit and quality practice in anaesthesia. The Royal College of Anaesthetists, June 1994.

(17.) Jefferson P, Ball DR. Endoscopy is useful during percutaneous tracheostomy. BMJ 2002; 324:977.

(18.) Cooper RM. Use and safety of percutaneous tracheostomy in intensive care. Report of a postal survey of ICU practice. Anaesthesia 1998; 53:1209-1212.

(19.) Velmahos GC, Gomez H, Boicey CM, Demetriades D. Bedside percutaneous tracheostomy: prospective evaluation of a modification of the current technique in 100 patients. World J Surg 2000; 24:1109-1115.

(20.) Shlugman D, Krishna-Satya R, Loh L. Acute fatal haemorrhage during percutaneous dilatational tracheostomy. BJA 2003; 90:517-520.

(21.) Kluge S, Meyer A, Kuhnelt P, Jorg Baumann H, Kreymann G. Percutaneous tracheostomy is safe in patients with severe thrombocytopenia. Chest 2004; 126:547-551.

(22.) Krishnan K, Elliot SC, Mallick A. The current practice of tracheostomy in the United Kingdom: a postal survey. Anaesthesia 2005; 60:360-364.

(23.) Kost KM. Endoscopic percutaneous dilatation tracheostomy. A prospective evaluation of 500 consecutive cases. Laryngoscope 2005; 115(Suppl):1-30.

(24.) Norwood S, Vallina VL, Short K, Saigusa M et al. Incidence of tracheal stenosis and other complications after percutaneous tracheostomy. Ann Surg 2000; 232:233-241.

(25.) Hatfield A, Bodenham A. Portable ultrasonic scanning of the anterior neck before percutaneous dilatational tracheostomy. Anaesthesia 1999; 54:660-663.

(26.) King D, Shlugman D, Satya-Krishna R, Loh L. Preventing bleeding complications in percutaneous tracheostomy-another role for portable ultrasound in intensive care. BJA 2003; 91:607-609.

(27.) Bunker N, Stone A, Higgins D, King D. The current practice of tracheostomy in the UK. Anaesthesia 2005; 60:933-934.

(28.) Mallick A, Venkatanath D, Eliot SC, Hollins T et al. A prospective randomised controlled trial of capnography vs. bronchoscopy for Blue Rhino[TM] percutaneous tracheostomy. Anaesthesia 2003; 58:864-868.

(29.) Benham SW Capnography detects tracheal tube placement but is it "correct?". Anaesthesia 2003; 58:1240.

(30.) Grundling M, Pavlovic D, Kuhn S.-O, Feyerherd F. Capnography vs. bronchoscopy for percutaneous tracheostomy placement. Anaesthesia 2004; 59:301-302.

J. F. COSGROVE*, A. SWEENIE ([dagger]), G. RAFTERY ([double dagger]), S. M. CAREY ([dagger]), A. J. KILNER *, I.D. NESBITT *, D.M. CRESSEY *, N. HIRSCHAUER ([dagger]), P.G. LAWS ([dagger]), D.W. RYAN *

Department of Perioperative and Critical Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom

* ER.C.A., Consultant in Anaesthesia and Critical Care. ([dagger]) ER.C.A., Specialist Registrar in Anaesthesia and Critical Care. ([double dagger]) M.R.C.P, Senior House Officer in Intensive Care Medicine.

Address for reprints: Dr J. E Cosgrove, Department of Perioperative and Critical Care, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, United Kingdom.
TABLE 1
Classification of immediate complications

Minor complications Major complications

Bleed (controlled by pressure) Bleed (requiring surgery)
Tracheal tube/cuff puncture Desaturation below 90%
Subcutaneous emphysema False passage
Posterior tracheal wall puncture Tension pnuemothorax
Difficult tracheostomy placement
Air leakage
Hypotension

Fikkers BG et al. Anaesthesia 2002; 57:1094-1097

TABLE 2
Immediate complications

Complication Patients Actual event Total
 (complications)

None 159

Minor 35 (40 inc. 2 with Bleed (controlled 24
 associated major by pressure)
 complications)

 Difficult tube 6
 placement *

 Endotracheal cuff 4
 puncture

 Posterior tracheal 2
 wall puncture *

 Subcutaneous 2
 emphysema *

 Posterior tracheal 1
 wall puncture

 Accidental 1
 extubation

Major 6 (with 2 Desaturation 3
 additional minor (to < 90%) *
 complications)

 Bleeding 1
 (requiring
 surgery)

 False passage * 1

 Pneumothorax 1

Mortality 0 0

* Difficult tube placement was associated with and contributed
to, two major complications (desaturation and false passage.)
Three minor complications (posterior tracheal wall puncture,
endotracheal cuff puncture and subcutaneous emphysema) were
also associated with difficult tube placement.

TABLE 3
Percutaneous tracheostomy and bleeding diathesis

Bleeding diathesis Underlying diagnosis Days
 ventilation
 prior to
 tracheostomy

Platelets <40x[10.sup.9]l

 Liver laceration 4

 Neutropenic sepsis 5

 Pneumonia and sepsis 5

 Pneumonia, sepsis, 5
 multiple sclerosis

 Liver transplant for 5
 fulminant hepatic
 failure

 Liver transplant for 7
 fulminant hepatic
 failure

 Sepsis 9

 Liver transplant, 11
 postoperative
 haemorrhage and
 multi-organ failure

 Liver laceration 15

PT >16s

 Lymphoma, pneumonia 4
 and sepsis

 Scoliosis surgery 4

 Encephalopathy and 5
 bleeding varices

 Encephalopathy and 6
 bleeding varices

Von Willebrand's
 Liver transplant for 6
 fulminant hepatic
 failure
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Author:Cosgrove, J.F.; Sweenie, A.; Raftery, G.; Carey, S.M.; Kilner, A.J.; Nesbitt, I.D.; Cressey, D.M.; H
Publication:Anaesthesia and Intensive Care
Date:Dec 1, 2006
Words:2793
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