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Clinical Trials/NCT05412823
NCT05412823
Recruiting
Not Applicable

Post Intubation Neurologic Outcomes in Critically Ill Adults

King Abdulaziz University1 site in 1 country1,000 target enrollmentJuly 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation Complication
Sponsor
King Abdulaziz University
Enrollment
1000
Locations
1
Primary Endpoint
Modified Rankin Scale (mRs)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The frequency of oxygen desaturation during emergency intubation is not uncommon. However, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. Therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients. Providing knowledge on whether the degree of hypoxia during emergency intubation is associated with worse neurologic outcomes, will guide clinical practice to ameliorate that level of hypoxia

Detailed Description

Critically ill patients undergoing emergent endotracheal intubation are at risk for oxygen desaturation in a variety of acute care settings. Such complication could arise from patient, operator, or procedure related factors. Evidence suggests that rapid sequence intubation (RSI) improves first-pass success and reduces complications in the critically ill. Nonetheless, the procedure is not without risks. In fact, emergency intubation is associated a reported oxygen desaturation rate of 10.9% - 33.5%. High quality pre-oxygenation has been shown to prolong time to desaturation during emergency airway management. Despite advances preoxygenation techniques, a significant number of patients undergoing emergency intubation still experience desaturation. Most of the time this is transient and easily reversible. Occasionally however, desaturation becomes critical and may result in devastating complications such as dysrhythmias or cardiopulmonary arrest. The brain consumes a significant amount of energy and is exquisitely sensitive to hypoxia and hypoperfusion. Hypoxic brain injury occurs whenever oxygen delivery to the brain is compromised. The role of secondary brain insults including hypoxia and hypotension, in traumatic brain injury (TBI) is well established. Previous literature has demonstrated that a single event of hypoxemia in a head-injured patient substantially increases morbidity and mortality. This has resulted in airway management being a cornerstone in the care of unconscious TBI patients, to ensure adequate oxygen delivery to the injured brain. However, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. Therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients.

Registry
clinicaltrials.gov
Start Date
July 22, 2022
End Date
August 1, 2027
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Abdullah Bakhsh

Assistant Professor of Emergency Medicine

King Abdulaziz University

Eligibility Criteria

Inclusion Criteria

  • Good baseline neurologic function (Modified Rankin Scale: 1-3)
  • Emergency departments
  • Critical care units
  • In-patient floors
  • Patients undergoing emergent intubations as determined by the treating physician
  • Age\> 17 years old
  • Good baseline modified rankin scale (mRs 1-3)

Exclusion Criteria

  • Pediatric patients (17 years of age of less)
  • Pregnant patients
  • Intubations occurring in the operating room
  • Prisoners
  • Status epilepticus
  • Primary intracranial pathology
  • Cardiopulmonary arrest
  • Poor baseline neurologic function (Modified Rankin Scale: 4-5)
  • Pre-Hospital Intubation

Outcomes

Primary Outcomes

Modified Rankin Scale (mRs)

Time Frame: Up to 30-days of intubation

A validated 6-point scale for measuring the degree of disability in the daily activities of people suffering neurological impairment. The scale runs from 0-6, in which "0" indicates perfect health without disability and "6" indicates the worst outcome which is death.

Secondary Outcomes

  • In-hospital Mortality(Up to 30-days of intubation)
  • ICU Length of Stay(Up to 30-days from intubation)
  • Hospital Length of Stay(Up to 30-days of intubation)
  • Incidence of Aspiration(Up to 14-days of intubation)
  • Post-Intubation Complications(Within 24-hours)

Study Sites (1)

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