Severe Head Injury Clinical Trial
Official title:
EARLY TRACHEOSTOMY VERSUS STANDARD OF CARE, A RANDOMIZED CONTROLLED CLINICAL TRIAL IN PATIENTS WITH SEVERE HEAD INJURY IN MULAGO HOSPITAL
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
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00152685 -
High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury
|
Phase 2/Phase 3 |