The NEUROlogically-impaired Extubation Timing Trial "NEURO-ETT"

Not yet recruiting

Phase 3 Results N/A

Trial Description

This randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness. It will directly compare (1) prompt extubation vs. (2) prompt tracheostomy vs. (3) usual care, with extubation or tracheostomy timed according to physicians' discretion. The primary outcome will be ICU free days (days spent alive and outside an ICU).

Detailed Description

Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. Extensive clinical research in weaning from mechanical ventilation has led to recommendations for prompt extubation following a successful trial of spontaneous breathing in general intensive care unit (ICU). However, little evidence exists to guide decisions about when to remove the breathing tube in patients with severe brain injury. It is unclear which of the following strategies would optimize important patient outcomes: prompt extubation vs. prompt tracheostomy vs. waiting and extubating or performing a tracheostomy, timed according to physicians' discretion. Each strategy has associated risks: prompt extubation may lead to higher rates of extubation failure and reintubation, prompt tracheostomy may lead to an excess of unnecessary procedures, and waiting longer may expose patients to complications from prolonged mechanical ventilation.This trial in brain-injured patients will test will of the following will lead to better patient outcomes: (1) removing the temporary breathing tube promptly; (2) performing a tracheostomy promptly; or (3) the usual treatment you would have received if you were not enrolled in this trial.

Conditions

Interventions

  • Usual care Other
    Intervention Desc: Patients in this group will be treated according to usual care, which may include extubation (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion. The inclusion of this arm will allow both intervention arms - prompt extubation and prompt tracheostomy - to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy. Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials.
    ARM 1: Kind: Experimental
    Label: Usual care
    Description: The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion
  • Tracheostomy Procedure
    Intervention Desc: This is an insertion of tracheostomy. Tracheostomy must be done within 48 hours of randomization. If for any reason the patient does not receive a tracheostomy according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified. We will remind the treating physician of the treatment assignment and ask them to reassess the patient for tracheostomy on a daily basis. If a patient is extubated instead of receiving a tracheostomy we will again record reasons for this, but the patient will be analysed in the tracheostomy group according to the intention-to-treat principle. In all participating centres, percutaneous tracheostomies are routinely performed in the ICU.
    ARM 1: Kind: Experimental
    Label: Tracheostomy
    Description: Insertion of a tracheostomy. Perform a tracheostomy, a neck surgery to insert a new tube directly into the windpipe (trachea), replacing the temporary breathing tube
  • Extubation Procedure
    Intervention Desc: This is an extubation by removal of endotracheal tube which must be done within 48 hours of randomization. Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team. Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team. If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified. If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle.
    ARM 1: Kind: Experimental
    Label: Extubation
    Description: Extubation by removal of endotracheal tube. Discontinuing the use of a breathing machine and removing the breathing tube, so that you may breathe on your own earlier and reduce the potential for harm related with prolong use of breathing machines

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary ICU Free Days 60 days No
Secondary Mortality, up to 6 months No
Secondary Ventilator-Free Days up to 60 days No
Secondary Airway Complications up to 60 days No
Secondary Nutrition Intake up to 6 months No
Secondary Antibiotic Days up to day 14 No
Secondary ICU Delirium up to day 14 No
Secondary Rate of Tracheostomy Insertion up to 6 months No
Secondary Rate of ICU Readmission up to hospital discharge No
Secondary Hospital Discharge Destination at hospital discharge No
Secondary Extended Glasgow Outcome Score up to 6 months No
Secondary EQ-5D up to 6 months No

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