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Title: Percutaneous Dilatational Tracheotomy in non-intensive care hospital wards: a new model

Authors:
Moshe Hain, MD*
Nimrod Adi, MD**
Yael�Polishuk,��R.N. M.A.**   
Yonatan Lahav, MD*
Doron Halperin, MD*




* Department of Otolaryngology-Head and Neck surgery, Kaplan Medical Center, Rehovot, affiliated with the Hebrew University- Hadassah Medical  School , Jerusalem, Israel.
** Intensive Care Unit, Kaplan Medical Center, Rehovot, affiliated with the Hebrew University- Hadassah Medical School, Jerusalem, Israel.
 
Financial disclosures: noneConflict of Interest: �None 
Word count: 2405

Correspondence: Moshe Hain, MD,  Department of Otolaryngology-Head and Neck surgery, Kaplan Medical Center P.O Box-1, Rehovot, Israel.
 Tel- 972-8-9441649, Fax- 972-8-9441794, E-Mail: rmhain@gmail.com







Abstract:

Percutaneous Dilatational Tracheotomy in non-intensive care hospital wards: A new model

Introduction:
	Percutaneous dilatational tracheotomy (PDT) is a widely applied procedure used mainly as a bedside procedure in intensive care unit (ICU) settings. The clinical and financial feasibility as compared to the traditional surgical �open� tracheotomy performed in the operating room, have been extensively studied and have been proven advantages on several accounts without compromising safety. We propose a working model for performing bedside PDT in non-ICU wards. 
Objectives:
To retrospectively assess the feasibility of bedside PDT in non-intensive care wards using a novel joint Otolaryngology- Intensive care Team model. A control group comprised of patients that underwent PDT in the ICU was used to assess the relative complication rate and outcome. 
Methods:
A working protocol was constructed defining all stages of the process. All early and late complications were recorded. Other parameters analyzed were patient epidemiology, pre-procedure morbidity, staff learning curve, duration of procedure, anesthetics administered, interval from ventilation to weaning and interval to decannulation. Endpoints were hospital discharge, decannulation and death. 
Results:
	From September 2009 until July 2010 a total of 98 PDT's were performed; 48 PDT�s were performed in the hospital wards, and 45 PDT�s were performed in the ICU. No life threatening complications were encountered in the non-ICU group and no significant difference in complication rate was observed between the two groups. 
Conclusion:
	Percutaneous tracheotomy is an available, safe, low cost procedure which may be safely performed bedside in the non ICU hospital wards by a qualified dedicated team. This novel approach, may greatly simplify the entire process of tracheotomy performance eliminating much of the excess time, hassle and cost, without compromising on safety and success rate.

Key Words: tracheotomy, percutaneous, bedside procedure




Percutaneous Dilatational Tracheotomy in non-ICU hospital wards: A new model

Introduction:
 The most common reason for tracheotomy in the hospital setting is prolonged endotracheal intubation1, with the majority of these patients hospitalized in the ICU and internal medicine wards2. Conversion of endotracheal intubation to tracheotomy allows for improved ventilation, hygiene, quality of life and rehabilitation. In this setting, tracheotomy is not an emergency procedure, but rather a semi-elective one. In many medical centers, tracheotomies for patients in the general wards are performed by an ENT surgeon, usually as an open surgical procedure, while ICU staff performs Percutaneous Dilatational Tracheotomy (PDT) for ICU patients. In some medical centers patients from general wards are transferred to the ICU for PDT performance and then returned to their ward

Ciaglia was the first to report the bedside PDT in 19853. Since then, the procedure has gained widespread popularity becoming the procedure of choice in many intensive care units worldwide1,4. Many variations of the procedure have been introduced including, serial dilation, forceps dilatation, endoscopic guidance, and ultrasound guidance2,3. Much data has accumulated as to the relative safety of this procedure and several meta-analyses comparing the traditional open tracheotomy with the percutaneous one, have generally concluded that there is no substantial difference in the overall complication rate1,5,6,7,8,9,10. 
The tracheotomy practice in our medical center until 2009 was as follows: All tracheotomies from non-ICU wards were performed in the operating room as an open surgical tracheotomy. Patients ventilated on non-ICU wards are located in designated rooms with defined monitoring and increased nurse to patient ratio. Each patients is monitored with continuous ECG recording, pulse oximeter and intermittent blood pressure measurements. There is a 1:3 nurse to patient ration. 
Patients in the ICU underwent PDT, when anatomically suited or when there was a high risk of transport to the operating room. 
Performing tracheotomies in the operating room harbors several inherent drawbacks. The procedure is defined as semi-elective, and as such, its' priority for the operating room is relatively low. This often leads to a substantial delay in the procedure, at times of up to a week or even longer. This delay puts the patient under unnecessary risks of prolonged endotracheal intubation, delays rehabilitation and results in unnecessary family frustration and tension. In addition, the transport of the critically ill patient from the ward to the operating room and back is potentially hazardous 11,12,13,14,15. From a financial perspective, the cost of open tracheotomy in the operating room is relatively high considering the facility and personnel requirements 7,8.
These factors encouraged us to establish a new paradigm for routine performance of PDT in all of the non-ICU wards. For this purpose, we assembled a joint team from the two departments most familiar and trained in airway management, the ICU and Otolaryngology department. We assembled a specially equipped cart just for this purpose in order to create a "mini ICU" on wheels.
Aside of the technical and surgical aspects, we also set a goal to improve the service by allowing for direct communication between our team and the other departments� staff, maintaining a high level of availability for the PDT team and increasing awareness and knowledge regarding tracheotomy care in all the wards.

Methods:
Beginning in September 2009 all tracheotomies in the non-ICU wards were PDT�s performed by the joint ENT-ICU team, unless contraindicated by anatomic or systemic considerations.
We retrospectively analyzed non-ICU PDT procedures done by the joint team and compared the results to a control group, composed of PDT  procedures done in the ICU for ICU patients. We collected data from patient files regarding epidemiology, baseline morbidity, and complications. The endpoints of our study were: discharge or transfer to another institution, successful weaning from tracheotomy cannula or death. 
We prepared a written detailed protocol explaining and defining all the necessary stages of the PDT process; beginning with the submission of request for tracheotomy from the wards to our PDT team through the steps of the actual procedure. The protocol was presented to the medical and nursing staff all of the relevant hospital wards. 

Procedure: 
We will briefly describe the entire process from request for tracheotomy through execution. The request for tracheotomy is sent from the ward to the PDT team coordinator, in our case the head ICU nurse. The request includes the patient�s I.D. and location along with a checklist which has been filled in by the attending ward physician16. An Otolaryngologist then examines the patient and reviews the chart, deciding if any anatomic or systemic contraindications to PDT exist 1,4,17. Once the Otolaryngologist has given the green light, the coordinator sets a time with the PDT team members. The ward staff is instructed to leave the patient NPO for six hours and discontinue anti-coagulation therapy for 12 hours prior to the set time of the procedure. The three member PDT team consisting of an ICU physician, otolaryngologist and an ICU nurse assemble at the patient�s bedside accompanied by a nurse from the ward.  
A mini-ICU setting is assembled with continuous monitoring of blood pressure, electrocardiogram, O2 saturation and end tidal CO2. The patient is sterilely draped and neck extended. The ICU physician is primarily responsible for the airway, hemodynamic and respiratory stability throughout the procedure. For the most part a standard protocol for sedation of I.V. Fentanyl 100 mcg, Midazolam 2-3 mg, Ketamin 50-100 mg and Vecuronium 10 mg was used.  As many of the patients are octogenarians with reduced effective blood volume due to diuretics and are treated with a combination of anti-hypertensive drugs, they suffer from a depressed autonomic reflex response to hypotension.   Taking these factors into account, the dosage was adjusted to suit the specific patient�s needs, often requiring lower dosages.
 The ICU nurse assists with all the necessary activities. The otolaryngologist then performs the PDT procedure and secures the tracheotomy cannula at the end of the procedure. Proper placement is confirmed clinically (auscultation and smooth passage of suction catheter) and by end tidal CO2 levels as we did not routinely use bronchoscopic guidance or confirmation. Post procedure instructions were given to the ward staff and a chest X-ray was mandatorily ordered to rule out respiratory complications including pneumothorax. Any immediate complications were recorded.

Results:
		In the 12 month period of this study from September 2009- August 2010, ninety seven PDTs were performed in our institution; 51 in the non ICU wards by our joint Otolaryngology �ICU PDT team and 46 in the ICU in the usual fashion. The ICU group was used as a control to the general ward group. 
There were statistically significant differences between these two groups with regard to age and gender (Table 1). The non-ICU patients were on an average 20 years older than the ICU patients and in the ICU group there were 73% males as opposed to 43% in the non-ICU wards. The two groups also differed as to the main reason for admission but this was not statistically significant. The most common reason for admission in the non-ICU group was respiratory failure in 51 % as opposed to the ICU group where the leading reasons were surgical etiology or trauma in 42 % (Table 2). Both groups had similar proportions of patients admitted for problems related to CNS and infection.
Pre-procedure morbidity was analyzed by comparing the patients� Norton score18 on admission, along with hemoglobin, creatinine and albumin levels immediately prior to the procedure. There was no significant difference between the two study groups. (Table 3). The mean APACHE score for the ICU group (not routinely recorded on the wards) was 20.46. The average time from request to performance of the procedure was approximately 36 hours.
 There was no significant difference in the complication rate between the two groups; 7% in non-ICU departments and 6% in the ICU (Table 4). In non-ICU wards there were three patients with early complications and one with a late complication and in the ICU one patient had an early complication and two experienced late complications. The incidence of major as opposed to minor complications was similar. In Table 5 we present the distribution of complications we encountered.
We had one case which was converted to an open tracheotomy. In this particular case the otolaryngologist was unable to advance the guide down the trachea, presumably due to interference with the endotracheal tube, and decided to switch to an open surgical procedure which was performed bedside in the internal medicine ward. The airway at all time was maintained with endotracheal intubation by the ICU team member and confirmed by capnography monitoring. The open procedure was uneventful.
Other complications encountered included bleeding both early and late. There was one patient with multiple complications which we will describe in detail. The patient was a 72 years old woman admitted and immediately operated on for fecal peritonitis. She later suffered from ischemic colitis and underwent three additional laparotomies. Due to prolonged intubation a PDT was performed in the ICU. During the procedure immediate signs of pneumothorax and pneumomediastinum appeared. The procedure was halted and the patient remained intubated. An open tracheotomy was later performed in the operating room. A trachea-esophageal fistula was diagnosed three weeks later and the patient was operated again for reconstruction. This patient died five weeks later due to massive gastro-intestinal bleeding and sepsis. Although not the direct cause of death, mediastinitis secondary to a tracheo-esophageal fistula could not be ruled out as the possible source of infection. 
There was no significant difference in the endpoint rates, i.e. weaning off the tracheotomy, transfer out of hospital and death (Table 6). The thirty day mortality for the ICU group was 9.6% compared to the average of 18% in our ICU. Although the groups were significantly different in age and reason for admission, and one could expect worse outcome in the Non ICU patients, this was not reflected in the complication rate or endpoints. 
The length of the procedure itself was between 3-5 minutes. The total time spent by the PDT team in ward was between 30-45 minutes. This was significantly shorter than an average of 102 minutes of open tracheotomy in the operating room.19

Discussion:  
Tracheotomy is a routine surgical procedure aiming to improve mechanical ventilation and patient�s quality of life 1,2,3. Unfortunately, due to hospital bureaucracy and the semi-elective nature of the procedure, its performance is often delayed. The advent of PDT has substantially simplified the matter, allowing it to be a bedside procedure. In most medical centers PDT performance is limited to the ICU or operating room, presumably for reasons of safety and surgical setup. We have created a new paradigm for introducing PDT as a routine bedside procedure in all hospital wards using a specialized and dedicated joint ENT-ICU three member team. We have shown in this retrospective series that this approach is both safe and effective. We experienced no difference in complication rate between the non-ICU group and the control group, nor any difference between our results and previously published data 4,5,6,7,20,21. Our approach substantially cut down waiting time and eliminated transfer of patients to the ICU or operating room. 
It must be stressed that as with all airway management, PDT remains a potentially hazardous procedure and harbors severe complications17. For this reason the members of the joint ICU-ENT Team must be well experienced in all aspects of airway control and must be experienced with PDT in all settings. We have reported several complications in our series including one pneumothorax and  tracheo-esophageal fistula , both potentially life threatening if not recognized early and treated promptly.
Although a limited series, we have demonstrated the feasibility of widespread use of bedside PDT in the non-ICU setting. Several important aspects of the procedure remain to be addressed: 
Endoscopic guidance:
As a rule we did not use endoscopic guidance during the procedure. It is used by some for two purposes. 1. during regression of the endotracheal tube to the glottic level before entering the trachea with the needle. 2. during puncture of the trachea and advancement of the guide-wire to assure correct placement in the tracheal lumen. Some authors advocate it�s use for both or one of these goals 3,4,21,22,23. In our experience there were few cases with �difficult anatomy� where the bronchoscopic approach may prove advantages but as a rule we feel that it is unnecessarily time consuming and cumbersome, adding staff requirements20 without adding to the safety and effectiveness of the procedure. 

Complications:
The heterogeneity in categories and definition of complication in the tracheotomy literature leads to a wide range of variability in the reported complication rates. Although some meta-analysis comparing PDT to the open surgical tracheotomy attempted to tackle these discrepancies and find a common ground for comparing data 5,8,20, this issue is still lacking clarity. We suggest for future trials to use accepted standard definitions for complications to allow more reliable comparison and meta-analysis of results.

Contraindications
With increasing experience the list of relative contraindications for PDT continues to shorten17,25. In our institution we have gone one more step towards allowing for widespread use of PDT as the standard routine tracheotomy procedure in the hands of an experienced team. Patients with unfavorable anatomy including short neck, difficulty in determining anatomic landmarks and lack of palpable midline structures may undergo PDT safely using endoscopic guidance, depending on the experience and confidence of the Team members17,21. Systemic factors such as high Positive End Expiratory Pressure requirements24 , hypoalbuminemia, anemia (hemoglobin<10),  and hypotension may no longer act as exclusion criteria  for PDT. As one of the key elements for successful PDT is constant airway control, the need for emergency airway access remains a contraindication to this procedure1. As we have gained more experience and confidence in PDT we now feel secure to �push the envelope" and perform PDT in patients with more difficult anatomy or generally at higher risk. Further studies are necessary to provide guidelines for contraindications in the high risk population.
	

Conclusion:
We propose this new model to all centers already well versed in PDT as a way of greatly improving the tracheotomy service. This approach provides improved patient care while cutting down institution costs, precious operating room time and ICU beds without any compromise to patient safety. 
We have learned the importance of close cooperation with the department staff- which is critical for good follow-up and post procedure care. Through renewing one's thinking, dedicated medicine, and a lot of hard work one can make a difference. We propose our joint ENT-ICU team model as a working paradigm to ensure the safety and well-being of the patient.

Acknowledgments:
We are indebted to Yael Polishuk (Head nurse, ICU, Kaplan Medical Center) who was a driving force behind this project.  Due to the nature of the work of the PDT Team, without the cooperation, enthusiasm and hard work of the nursing staff this dream could not have become a reality.
We would also like to thank Ronen Fluss PhD for his assistance with the statistical analysis and reporting of results.

Bibliograpghy:

 Leyn PD, Bedert L, Delcroix M et al. Tracheotomy: clinical review and guidelines. European J of cardio-thoracic surgery 2007;32:412-421 
Epstein SK. Anatomy and physiology of tracheotomy. Respiratory care 2005;50(3):476-482
Durbin Jr CJ. Techniques for performing tracheotomy. Respiratory care 2005;50(4):488-496
Kost KM. Endoscopic Percutaneous dilatational tracheotomy: a prospective evaluation of 500 consecutive cases. Laryngoscope 2005;115:1-30
Freeman BD, Isabella K, Lin N et al. A Meta-analysis of Prospective Trials Comparing Percutaneous and Surgical Tracheotomy in Critically Ill Patients. Chest 2000;1181412-1418
Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheotomy in critically ill patients: a systemic review and meta-analysis. Critical care 2006;10:R55  
Higgins KM, Punthakee X. Meta-analysis comparison of open versus percutaneous tracheotomy. Laryngoscope 2007;117:447-454
Freeman BD, Isabella K, Cobb P. et al. A prospective randomized trial comparing Percutaneous tracheotomy with surgical tracheotomy in critically ill patients. Critical care med 2001;29(5):926-930
Cheng E, Fee WE Jr., Dilatational versus standard tracheostomy: a meta- analysis. Ann Otol Rhinol Laryngol 2000;109:803-807
Dulguerov P, Gysin C, Perneger TV et al. Percutaneous or surgical tracheostomy: a meta-analysis. Crit Care Med 1999;27:1617-1625
Warren J, Fromm RE Jr., Orr RA et al. Guidelines for inter- and intrahospital transport of critically ill patients. Crit Care Med 2004;32:256-262
Waydhas C. Intrahospital transport of critically ill patients. Crit Care 1999;3:R83-89
Beckmann U, Gillies DM, Berenholtz SM et al. Incidents relating to the intrahospital transfer of critically ill patients. An analysis of the reports submitted to the Australian Incident Monitoring Study in intensive care. Intensive Care Med 2004;30:1579-1585
Lovell Ma, Mudaliar MY, Klinberg PL. Intrahospital transport of critically ill patients: complications and difficulties. Anaesth Intensive Care 2001;29:400-405
Smith I, Fleming S, Gernainu CG et al. Mishaps during transport from the intensive care unit. Crit Care Med. 1990;18:278-281
checklist includes: concise medical history, medical indication for tracheotomy, informed consent, current blood count, clotting function (PT,PTT), current CXR, valid blood cross, anti-coagulation status.
Blankenship DR, Kulbersh BD, Gourin CG et al.  High risk tracheostomy: exploring the limits of the percutaneous tracheostomy. Laryngoscope 2005;115(6):987-989
The Norton scale is used for pressure ulcer risk assessment. The scale includes: general physical condition, mental state, activity, mobility and incontinence (Norton et al. 1975). The score is calculated by the nursing staff on admission for every patient hospitalized in our institution and was therefore used as an objective, accessible parameter of baseline morbidity. For the ICU group we have added the APACHE score and 30 day mortality.
Data collected in our institution of 175 open surgical tracheotomies performed in the OR in 2008-2009.
Polderman KH, Spijkstra JJ, de Bree R et al. Percutaneous Dilatational Tracheotomy in the ICU: Optimal Organization, Low Complication Rates, and Description of a New Complication. Chest 2003;123;1595-1602
Kornblith LZ, Burlew CC, Moore EE et al. One thousand bedside Percutaneous tracheostomies in the surgical intensive care unit: Time to change the gold standard. J. Am. Coll. Surg. 2011;212(2):163-170
Oberwalder M, Weis H, Nehoda H. et al. Videobronchoscopic guidance makes percutaneous dilatational tracheostomy safer. Surg Endosc 2004;18(5):839-842
Fernandez L, Norwood S, Roettger R et al. Bedside Percutaneous tracheostomy with bronchoscopic guidance in critically ill patients. Arch Surg 1996;131(2):129-132
Beiderlinden M, Groeben H, Peters J. Safety of Percutaneous dilatational tracheostomy in patients ventilated with high positive end-expiratory pressure (PEEP). Intensive Care Med 2003;29:944-948
Tabaee A, Geng E, Lin J et al. Impact of neck length on the safety of Percutaneous and surgical tracheotomy: a prospective, randomized study. Laryngoscope 2005; 115(9):1685-1690


Tables:
Table 1:
Epidemiologic Data
Non-ICUICUNo. of patients5146Total: 97Age: average (SD)81.3 (10.2)61(17.4)P-value<0.0001Gender- Males22(43.1%)33(73.3%)Chi-squared test
0.005
Table 2: Reason of admission

General Wards (%)Intensive Care Unit (%)Respiratory failure518.9Cardiovascular failure5.915.6Infection 21.624.4Central nervous system7.88.9Surgical /Trauma7.872.2Others 5.90




Table 3: Pre-procedure morbidity

General Wards
meanIntensive Care Unit
meanT-test
p-valueNorton Score98.20.165Albumin2.32.20.420Creatinine1.21.20.945Hemoglobin9.69.50.968




Table 4: Complications (per-procedure)

Non-ICUICUp-ValueEarly 3(5%)1(2%)NSLate 1(1%)2(4%)NSTotal 4(7%)3(6%)NS
Table 5: Distribution of complications
Non ICUICUEarlyConversion to open10Pneumothorax01*Pneumo-mediastinum01*Minor early bleeding21Late Major late bleeding11Tracheo-esophageal fistula01*Total 45	* Same patient




Table 6: Study endpoints
Non ICUICUP-ValueWeaned (decannulated)3 (5.9%)7 (15.6%)0.18Transferred to other institution25 (49%)18 (40%)0.42Overall mortality20 (39.2%)18 (40%)1.0 













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