Early Tracheostomy Versus Standard of Care in Patients With Severe Head Injury

NCT02442154 | Completed

• 1 other identifier: 2013/HD07/2134U
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Severe head injury is associated with airway compromise and poor respiratory effort. In Mulago Hospital intubation is the mainstay intervention and then patients are subjected to the wait and see strategy of delayed or no tracheostomy, very few undergo early tracheostomy, and some patients are left without an artificial airway.Using endotracheal tubes is associated with complications which have been shown to increase intensive care unit (ICU) and hospital stay, morbidity and mortality. Tracheostomy has been reported to have advantages over translaryngeal intubation but the optimal timing of tracheostomy in patients with severe head injury is controversial. Studies done elsewhere have showed that patients with severe head injury who undergo early tracheostomy have better survival outcomes but no studies have been done in our setting

Conditions

Severe Head Injury

Keywords

early tracheostomy; severe head injury; endotracheal intubation

Outcome Measures

Primary Outcomes (1)

• 30day mortality

  the number of deaths recorded within 30days of admission

  within 30 days of follow up

Secondary Outcomes (4)

• length of ICU and hospital stay

  30 days

• incidence of ventilator associated pneumonia

  30days

• duration of sedation

  30days

• Glasgow coma scale on discharge

  30days

Study Arms (2)

Early tracheostomy

EXPERIMENTAL

To do an early tracheostomy within 24hours of admission of the severely head injured patients

Procedure: Tracheostomy

standard of care

NO INTERVENTION

To use the standard of care of mulago hospital for the management of the severely head injured patients

Interventions

Tracheostomy PROCEDURE

It is a surgical procedure which involves making an incision on the anterior aspect of the neck and opening a direct airway through an incision in the trachea with stitching the trachea to the skin and placement of a tube

Early tracheostomy

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 10years
• GCS ≤ 8

You may not qualify if:

• Patients who undergo tracheostomies within 24hours of admission before randomization

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Mulago Hospital Complex

Kampala, Kampala, 256, Uganda

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Ostomy; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Arthur Kwizera, Mmed

  Makerere Univervisity college of health science

  STUDY DIRECTOR

• Juliet Nalwoga, MBChB

  Makerere University college of health science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 13, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 18, 2016

Record last verified: 2015-08

Locations

UG (1)