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Early Tracheostomy Versus Standard of Care in Patients With Severe Head Injury (E-Trac)

Primary Purpose

Severe Head Injury

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Tracheostomy
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Head Injury focused on measuring early tracheostomy, severe head injury, endotracheal intubation

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients above 10years
  • GCS ≤ 8

Exclusion Criteria:

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

Sites / Locations

  • Mulago Hospital Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early tracheostomy

standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

30day mortality
the number of deaths recorded within 30days of admission

Secondary Outcome Measures

length of ICU and hospital stay
number of days spent in the ICU and hospital
incidence of ventilator associated pneumonia
Number of days on the mechanical ventilator and development of VAP for the mechanically ventilated patients using; increase in respiratory rate, Fraction of inspired oxygen (FiO2), temperature and White blood cell count from the baseline, consistency of the tracheal aspirate and culture of the tracheal aspirate
duration of sedation
number of days the patient receives sedatives
Glasgow coma scale on discharge
level of consciousness on discharge

Full Information

First Posted
April 29, 2015
Last Updated
March 17, 2016
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT02442154
Brief Title
Early Tracheostomy Versus Standard of Care in Patients With Severe Head Injury
Acronym
E-Trac
Official Title
EARLY TRACHEOSTOMY VERSUS STANDARD OF CARE, A RANDOMIZED CONTROLLED CLINICAL TRIAL IN PATIENTS WITH SEVERE HEAD INJURY IN MULAGO HOSPITAL
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Introduction; Most patients with severe head injury cannot protect their airway, have excessive secretions and inadequate spontaneous breathing which contributes to cerebral hypoxia. Thus, in their initial management the airway is secured with either an endotracheal tube (ETT) or a tracheostomy. In Mulago Hospital some of these patients are intubated and then 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. 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 outcomes. Problem statement; Mulago hospital receives the largest number of patients with severe head injured with a mortality rate of 69%. Securing these patients airway using ETT is associated with complications which have been shown to increase ICU and hospital stay, morbidity and mortality. Furthermore, most intubated patients often require ICU admission for care of ETT and mechanical ventilation and yet these patients require little or no assistance from mechanical ventilation if the airway has been secured with a tracheostomy. With limited number of ventilators and beds in ICU and increased demand for ICU admission in Mulago hospital, this poses a challenge. Objective; To compare 30 day mortality of severe head injured patients undergoing early tracheostomy versus standard of care in Mulago Hospital and the associated factors Methodology; Randomized controlled clinical trial, open label, to be carried out in Mulago Hospital Trauma Centre, casualty, ICU, and neuro-surgical ward high dependence unit (3AHDU). All patients above 10years with severe traumatic brain injury who meet the study criteria will be recruited and randomly assigned to either arm. The patients on the early tracheostomy arm will undergo tracheostomy, done by an Otolaryngologist (ENT surgeon) or resident within 24 hours of admission, then admitted either in trauma center, ICU if there is space available, or Neurosurgery ward HDU. Patients will then receive routine care for the severe head injured patients as per Mulago hospital standards. On the other arm the patients will receive the standard of care as per the attending clinician, and these are also admitted either in trauma Centre, ICU or Neurosurgery ward HDU where they also receive routine care for severe head injured patients as per Mulago hospital standards. Follow up the primary outcome is 30day mortality The patients on both arms will be followed up for a maximum of 30 days To assess for; Acute complications of the tracheostomy (bleeding, subcutaneous emphysema, pneumothorax) Number of days on the mechanical ventilator and development of ventilator associated pneumonia (VAP) for the mechanically ventilated patients using; increase in respiratory rate, FiO2, temperature and White blood cell count from the baseline, consistency of the tracheal aspirate and culture of the tracheal aspirate. Number of days patient requires sedation for the sedated patients. Length of ICU and hospital stay and glasgow coma scale (GCS) at discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Head Injury
Keywords
early tracheostomy, severe head injury, endotracheal intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early tracheostomy
Arm Type
Experimental
Arm Description
To do an early tracheostomy within 24hours of admission of the severely head injured patients
Arm Title
standard of care
Arm Type
No Intervention
Arm Description
To use the standard of care of mulago hospital for the management of the severely head injured patients
Intervention Type
Procedure
Intervention Name(s)
Tracheostomy
Intervention Description
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
Primary Outcome Measure Information:
Title
30day mortality
Description
the number of deaths recorded within 30days of admission
Time Frame
within 30 days of follow up
Secondary Outcome Measure Information:
Title
length of ICU and hospital stay
Description
number of days spent in the ICU and hospital
Time Frame
30 days
Title
incidence of ventilator associated pneumonia
Description
Number of days on the mechanical ventilator and development of VAP for the mechanically ventilated patients using; increase in respiratory rate, Fraction of inspired oxygen (FiO2), temperature and White blood cell count from the baseline, consistency of the tracheal aspirate and culture of the tracheal aspirate
Time Frame
30days
Title
duration of sedation
Description
number of days the patient receives sedatives
Time Frame
30days
Title
Glasgow coma scale on discharge
Description
level of consciousness on discharge
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients above 10years GCS ≤ 8 Exclusion Criteria: Patients who undergo tracheostomies within 24hours of admission before randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Kwizera, Mmed
Organizational Affiliation
Makerere Univervisity college of health science
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juliet Nalwoga, MBChB
Organizational Affiliation
Makerere University college of health science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Hospital Complex
City
Kampala
ZIP/Postal Code
256
Country
Uganda

12. IPD Sharing Statement

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

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