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NCT Number: NCT05412823

Neurologic Function Post Intubation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

Location status: Recruiting

Location contact

Abdullah Bakhsh

CONTACT

[email protected]

+966 555080287

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. In-hospital Mortality

    Time frame: Up to 30-days of intubation

    Death during hospital stay

  2. ICU Length of Stay

    Time frame: Up to 30-days from intubation

    Duration of stay in intensive care unit

  3. Hospital Length of Stay

    Time frame: Up to 30-days of intubation

    Duration of stay in hospital

  4. Incidence of Aspiration

    Time frame: Up to 14-days of intubation

    Pulmonary aspiration confirmed by chest X-ray or chest CT

  5. Post-Intubation Complications

    Time frame: Within 24-hours

    Complications arising during the early post-intubation phase

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah Bakhsh

CONTACT

[email protected]

+966 555080287

Asseil Bossei

CONTACT

[email protected]

+966 551500666

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Post Intubation Neurologic Outcomes in Critically Ill Adults

Acronym: NeuroHypoxia

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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