Comparison Between Immediate and Gradual Decannulation

Kaplan Medical Center

Status: Unknown

Conditions: Tracheostomy

Treatments: Other: outpatient clinic follow ups; Other: Pre-discharge evaluation; Procedure: Gradual tracheostomy tube decrease; Procedure: immediate decannulation; Other: Overnight observation

Study type: Interventional

Funder types: Other

Identifiers

NCT02469909

ENTK 34-CTIL

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who underwent tracheostomy with the following conditions:

1. Tracheostomy tract is established more than 7 days
2. Normal vital signs: heart rate 50-100, 90<systolic BP <180, respiratory rate <20. Saturation >90% in room air
3. Effective cough
4. Normal swallows \ feeding possibility

5. steps endoscopy test: through the tracheostomy tube, normal naso-laryngeal and through the tract with an upper look towards the subglottic area in order to detect subglottic stenosis.

6. Ability of the patient to breath with a capped cannula.

Exclusion criteria

• Patients with a major complication in tracheostomy procedure (subcutaneous emphysema, pneumothorax, bleeding, false root)
• patient with anatomical neck abnormality
• Pregnant women

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who underwent tracheostomy with the following conditions:

1. Tracheostomy tract is established more than 7 days
2. Normal vital signs: heart rate 50-100, 90<systolic BP <180, respiratory rate <20. Saturation >90% in room air
3. Effective cough
4. Normal swallows \ feeding possibility

5. steps endoscopy test: through the tracheostomy tube, normal naso-laryngeal and through the tract with an upper look towards the subglottic area in order to detect subglottic stenosis.

6. Ability of the patient to breath with a capped cannula.

Exclusion criteria

• Patients with a major complication in tracheostomy procedure (subcutaneous emphysema, pneumothorax, bleeding, false root)
• patient with anatomical neck abnormality
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

immediate decannulation

Other group

Description:

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

Treatment:

Other: Pre-discharge evaluation

Other: outpatient clinic follow ups

Other: Overnight observation

Procedure: immediate decannulation

Gradual tracheostomy tube decrease

Other group

Description:

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

Treatment:

Procedure: Gradual tracheostomy tube decrease

Other: outpatient clinic follow ups