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| Name | Class |
|---|---|
| Soroka University Medical Center | OTHER |
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The investigators propose to examine the feasibility and safety of immediate (single stage) decannulation in adult patients in a controlled randomized trial. Patients who will be found fit for decannulation after an otolaryngologist and intensive care specialist assessment will be randomized into two groups: immediate decannulation and gradual decrease in cannula size. Both groups of patients will be monitored after decannulation and in the outpatient clinic for any complications following the procedure.
Recruitment of the patients will be demands for decannulation evaluation of different departments in our institution. All patients who will agree to participate in the study and meet the inclusion criteria would undergo three major steps"
Pre decannulation evaluation by otolaryngologist and intensive care specialist following inclusion criteria.
Decannulation:
In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient.
In the gradual decannulation group:
The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation.
Follow up:
All patients would be followed in 7, 30, 90 days following decannulation in the outpatient clinic or in their departments if still hospitalized. In these visit questionnaires regarding possible respiratory complications will be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate decannulation | Other | In the immediate decannulation group - the tracheostomy tube is removed and the patient would be monitored overnight in an intermediate monitored unit. On the next day a clinical evaluation would be held, and the patient would be discharge or transferred to his department according to the clinical course of the patient |
|
| Gradual tracheostomy tube decrease | Other | In the gradual decannulation group The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overnight observation | Other | patients in the immediate decannulation group would be admitted for an overnight in intensive care unit or the otolaryngology department. they would be monitored for any respiratory or airway complications. |
| Measure | Description | Time Frame |
|---|---|---|
| re-insertion of the tracheostomy tube | number of patients who needed re-insertion of the tracheostomy tube due to respiratory distress within 7 days of decannulation | 7 days |
| mechanical ventilation | number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | number of patients who died from any cause within 90 days of decannulation | 90 days |
| Respiratory distress | number of patients who reported difficulty breathing suggestive of stridor or by examination or intervention within 90 days of decannulation |
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Inclusion Criteria:
Patients who underwent tracheostomy with the following conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oded Cohen, Dr | Contact | +972-544682490 | oded915@gmail.com | |
| Yaara Haimovich | Contact | +972-52-8580806 | yaaraha@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Nili Segal, Dr | Soroka hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaplan medical center | Recruiting | Rehovot | Rehovot | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15807905 | Background | Epstein SK. Anatomy and physiology of tracheostomy. Respir Care. 2005 Apr;50(4):476-82. | |
| 16606435 | Background | Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. doi: 10.1186/cc4887. |
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| Pre-discharge evaluation | Other | After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases. |
|
| outpatient clinic follow ups | Other | all patients would visit the otolaryngology outpatient clinic in 7, 30 and 90 days following decannulation for an evaluation of any respiratory complications following decannulation |
|
| immediate decannulation | Procedure | the tracheostomy tube is removed at once |
|
| Gradual tracheostomy tube decrease | Procedure | The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation |
|
| up to 90 fays following decannulation |
| Pneumonia | number of patients who had a diagnosis of pneumonia in the period of 90 days following decannulation | 90 days following decannulation |
| 15807916 | Background | Pierson DJ. Tracheostomy and weaning. Respir Care. 2005 Apr;50(4):526-33. |
| 15807918 | Background | Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41. |
| 10155745 | Background | Heffner JE. The technique of weaning from tracheostomy. Criteria for weaning; practical measures to prevent failure. J Crit Illn. 1995 Oct;10(10):729-33. |
| 15807917 | Background | Lewarski JS. Long-term care of the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):534-7. |
| 22990518 | Result | Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18. |
| 17588767 | Result | De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27. |