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

Phase 2

Completed

• Conditions: Tracheostomy Complication
• Interventions: Device: Tracheostomy tube

• Registration Number: NCT03431389
• Lead Sponsor: Assiut University

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. proper timing of tracheostomy

2. process of decannulation.

Detailed Description

Tracheostomy is described as the creation of a stoma at the skin surface which leads into the trachea. From the first tracheostomy until about 1930, the operation was performed exclusively for laryngeal obstruction. Nowadays, due to the development of the care of critically ill patients in intensive care units (ICUs), there are other indications for the procedure including prolonged intubation and pulmonary toilet.

The initial management of patients in an intensive care unit involves a series of interventions that aim to stabilize and then optimize their physiological state. Mechanical ventilation (MV) is a commonly utilized intervention to support a patient's respiratory function. The second phase in ICU management focuses on weaning the patient from the artificial supportive mechanisms.

The principle role of tracheostomy in the ICU is to expedite the weaning process in patients requiring prolonged mechanical ventilation and those predicted to be at risk of pulmonary aspiration. Tracheostomy facilitates weaning primarily by allowing increased level of patient activity and mobility.

Tracheostomy protects the larynx and the upper airway from prolonged intubation which may lead to laryngotracheal stenosis. Patients with tracheostomies tend to have fewer days of mechanical ventilation because of the improvements in the respiratory physiology. This is especially in trauma patients. They have improved secretion clearance as suction is easy and less strength is required for expectoration. This may be linked to the lower incidence of pneumonia and respiratory infections seen, especially in trauma victims.

Patients with tracheostomy are less sedated and therefore able to move in bed. The patients may also be able to swallow, so may be started on oral feeding sooner and mouth care is easier compared with an endotracheal tube (ETT) tube.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2016-05-31
• Study Completion: 2016-05-31
• Status Verified: 2018-02
• Study First Submitted: 2018-02-03
• Study First Submitted QC: 2018-02-10
• Last Update Submitted: 2018-02-10
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decannulated group	Tracheostomy tube	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.
Failure of decannulation group	Tracheostomy tube	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.

Primary Outcome Measures

Name	Time	Method
Successful decanulation	6 month	Trial of decannulation was considered successful, if there was no need to reapply tracheostomy within 6 months of decannulation.

Trial Locations

Locations (1)

Assiut university main hospital, ICUs; 🇪🇬 Assiut, Assiut Governorate, Egypt