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

NCT02442154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2016-03-18

No results posted yet for this study

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

Interventions

PROCEDURE

Tracheostomy

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

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Arthur Kwizera, Mmed · Makerere Univervisity college of health science

  • Juliet Nalwoga, MBChB · Makerere University college of health science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Uganda

Study Locations

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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 NCT02442154 on ClinicalTrials.gov