NeuroHypoxia: Neurologic Function Post Intubation

Sponsor
King Abdulaziz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05412823
Collaborator
(none)
1,000
1
60.3
16.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post Intubation Neurologic Outcomes in Critically Ill Adults
    Actual Study Start Date :
    Jul 22, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2027
    Anticipated Study Completion Date :
    Aug 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Hypoxic group

    Participants with hypoxia during intubation (after induction and before endotracheal tube placement)

    Non-hypoxic group

    Participants without hypoxia during intubation (after induction and before endotracheal tube placement)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. In-hospital Mortality [Up to 30-days of intubation]

      Death during hospital stay

    2. ICU Length of Stay [Up to 30-days from intubation]

      Duration of stay in intensive care unit

    3. Hospital Length of Stay [Up to 30-days of intubation]

      Duration of stay in hospital

    4. Incidence of Aspiration [Up to 14-days of intubation]

      Pulmonary aspiration confirmed by chest X-ray or chest CT

    5. Post-Intubation Complications [Within 24-hours]

      Complications arising during the early post-intubation phase

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King Abdulaziz University Hospital Jeddah Saudi Arabia

    Sponsors and Collaborators

    • King Abdulaziz University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Abdullah Bakhsh, Assistant Professor of Emergency Medicine, King Abdulaziz University
    ClinicalTrials.gov Identifier:
    NCT05412823
    Other Study ID Numbers:
    • KAUJED
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Abdullah Bakhsh, Assistant Professor of Emergency Medicine, King Abdulaziz University

    Study Results

    No Results Posted as of Aug 16, 2022