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" 1. Pre decannulation evaluation by otolaryngologist and intensive care specialist following inclusion criteria. 2. 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. 3. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.
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
Kaplan medical center
Rehovot, Rehovot, Israel
RECRUITINGre-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
Time frame: 7 days
mechanical ventilation
number of patients who needed mechanical ventilation due to respiratory distress within 7 days of decannulation
Time frame: 7 days
Death from any cause
number of patients who died from any cause within 90 days of decannulation
Time frame: 90 days
Respiratory distress
number of patients who reported difficulty breathing suggestive of stridor or by examination or intervention within 90 days of decannulation
Time frame: up to 90 fays following decannulation
Pneumonia
number of patients who had a diagnosis of pneumonia in the period of 90 days following decannulation
Time frame: 90 days following decannulation
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the tracheostomy tube is removed at once
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