"Outcomes of Tracheostomy Done for Patients Admitted in Anesthesia Intensive Care Units of Assiut University Hospital"

NCT03431389 | Completed Phase 2 DMC

• 1 other identifier: IRB00008718/00045
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This study was undertaken to Identify the factors affecting the outcomes of tracheostomy done in ICU for patients subjected to prolonged intubation and ventilation and to suggest guidelines to control:

1. 1.proper timing of tracheostomy
2. 2.process of decannulation.

Conditions

Tracheostomy Complication

Outcome Measures

Primary Outcomes (1)

• Successful decanulation

  Trial of decannulation was considered successful, if there was no need to reapply tracheostomy within 6 months of decannulation.

  6 month

Study Arms (2)

Decannulated group

ACTIVE COMPARATOR

Decannulation was considered when the patients were no longer in need for tracheostomy tube and fulfilled the criteria of decannulation: No need for mechanical ventilation, no chocking with oral intake, no chest infection, effective cough reflex, laryngeal examination show bilateral mobile vocal cords with sufficient gap. Trial of decannulation was considered successful, if there was no need to reapply tracheostomy within 6 months of decannulation.

Device: Tracheostomy tube

Failure of decannulation group

ACTIVE COMPARATOR

Decannulation was considered when the patients were no longer in need for tracheostomy tube and fulfilled the criteria of decannulation: No need for mechanical ventilation, no chocking with oral intake, no chest infection, effective cough reflex, laryngeal examination show bilateral mobile vocal cords with sufficient gap. Decannulation trail was considered failed if there was a need to reapplication of tracheostomy at the time of decannulation or within six months of decannulation the duration of follow up.

Device: Tracheostomy tube

Interventions

Tracheostomy tube DEVICE

Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre.

Also known as: TT

Decannulated group; Failure of decannulation group

Eligibility Criteria

• Age: 1 Year - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who were admitted to the ICUs of the main Assiut University Hospital.
• mechanically ventilated and
• underwent tracheostomy during his/her stay in ICU.

You may not qualify if:

• Patients who were admitted to ICUs and didn't need tracheostomy during the period of admission in ICU or after discharge from ICU,
• Patients who died during admission in ICUs before being tracheostomized,
• Patients who died during admission in ICUs after being tracheostomized and the cause of death was not related to the tracheostomy procedure or care.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university main hospital, ICUs

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Interventions

Tracheostomy Decannulation

Intervention Hierarchy (Ancestors)

Tracheostomy; Airway Management; Therapeutics; Device Removal; Surgical Procedures, Operative; Ostomy; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Hala S Abdelghaffar, MD

  Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Model Details: Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre. The patients were followed up daily until discharge from ICU. The following items were recorded: Duration of application of tracheostomy tube before decannulation (cannulation time), complications of tracheostomy, mortality due to tracheostomy.

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: February 13, 2018
• Study Start: June 1, 2015
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)