MedTrace Logo

Comparison Between Immediate and Gradual Decannulation

NCT02469909 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Tracheostomy

Interventions

OTHER

Overnight observation

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.

OTHER

Pre-discharge evaluation

After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.

OTHER

outpatient clinic follow ups

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

PROCEDURE

immediate decannulation

the tracheostomy tube is removed at once

PROCEDURE

Gradual tracheostomy tube decrease

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

Sponsors & Collaborators

  • Soroka University Medical Center

    collaborator OTHER

  • Kaplan Medical Center

    lead OTHER

Principal Investigators

  • Nili Segal, Dr · Soroka hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-06-30
Completion
2019-01-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469909 on ClinicalTrials.gov