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Neurologic Function Post Intubation

Post Intubation Neurologic Outcomes in Critically Ill Adults

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05412823
Acronym
NeuroHypoxia
Enrollment
1000
Registered
2022-06-09
Start date
2022-07-22
Completion date
2027-08-01
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

Keywords

Emergency Intubation, Hypoxia, Neurologic Function

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.

Interventions

None listed

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale (mRs)Up to 30-days of intubationA 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

MeasureTime frameDescription
In-hospital MortalityUp to 30-days of intubationDeath during hospital stay
ICU Length of StayUp to 30-days from intubationDuration of stay in intensive care unit
Hospital Length of StayUp to 30-days of intubationDuration of stay in hospital
Incidence of AspirationUp to 14-days of intubationPulmonary aspiration confirmed by chest X-ray or chest CT
Post-Intubation ComplicationsWithin 24-hoursComplications arising during the early post-intubation phase

Countries

Saudi Arabia

Contacts

Primary ContactAbdullah Bakhsh
aarbakhsh@kau.edu.sa+966 555080287
Backup ContactAsseil Bossei
asseil.a.b.95@gmail.com+966 551500666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026