Neurologic Function Post Intubation

Recruiting

• Conditions: Intubation Complication

• Registration Number: NCT05412823
• Lead Sponsor: King Abdulaziz University

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.

Study Timeline

• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Study Start: 2022-07-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16
• Primary Completion: 2027-06-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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
• Trauma
• Status epilepticus
• Primary intracranial pathology
• Cardiopulmonary arrest
• Poor baseline neurologic function (Modified Rankin Scale: 4-5)
• Pre-Hospital Intubation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRs)	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 Outcome Measures

Name	Time	Method
ICU Length of Stay	Up to 30-days from intubation	Duration of stay in intensive care unit
In-hospital Mortality	Up to 30-days of intubation	Death during hospital stay
Hospital Length of Stay	Up to 30-days of intubation	Duration of stay in hospital
Incidence of Aspiration	Up to 14-days of intubation	Pulmonary aspiration confirmed by chest X-ray or chest CT
Post-Intubation Complications	Within 24-hours	Complications arising during the early post-intubation phase

Trial Locations

Locations (1)

King Abdulaziz University Hospital; 🇸🇦 Jeddah, Saudi Arabia