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Intubation ComplicationNeuroHypoxiaNCT05412823

Neurologic Function Post Intubation

An observational study of Intubation Complication, run by King Abdulaziz University at 1 site in Saudi Arabia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intubation Complication
How many people
1,000 participants
Where
1 siteSaudi Arabia
Study dates
22 Jul 2022to 1 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Critically ill adults requiring emergency intubation based on the treating clinician

Who may be able to join

  • 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)

Who cannot join

  • Pediatric patients (17 years of age of less)
  • Pregnant patients
  • Intubations occurring in the operating room
  • Prisoners
  • Trauma
  • Status epilepticus
Show all 10Show fewer
  • Primary intracranial pathology
  • Cardiopulmonary arrest
  • Poor baseline neurologic function (Modified Rankin Scale: 4-5)
  • Pre-Hospital Intubation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abdullah Bakhsh contact

+966 555080287

aarbakhsh@kau.edu.sa

Asseil Bossei contact

+966 551500666

asseil.a.b.95@gmail.com

Saudi Arabia1 site, 1 recruiting

  • King Abdulaziz University Hospital

    Jeddah

    Abdullah Bakhsh, +966 555080287, aarbakhsh@kau.edu.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Post Intubation Neurologic Outcomes in Critically Ill Adults

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

Read the 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.

Keywords
Emergency Intubation, Hypoxia, Neurologic Function
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05412823
Study groupRoleWhat they receive
Hypoxic groupParticipants with hypoxia during intubation (after induction and before endotracheal tube placement)
Non-hypoxic groupParticipants without hypoxia during intubation (after induction and before endotracheal tube placement)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale (mRs)

    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.

    Measured: Up to 30-days of intubation

Secondary outcomes (5)

  1. In-hospital Mortality

    Death during hospital stay

    Measured: Up to 30-days of intubation

  2. ICU Length of Stay

    Duration of stay in intensive care unit

    Measured: Up to 30-days from intubation

  3. Hospital Length of Stay

    Duration of stay in hospital

    Measured: Up to 30-days of intubation

  4. Incidence of Aspiration

    Pulmonary aspiration confirmed by chest X-ray or chest CT

    Measured: Up to 14-days of intubation

  5. Post-Intubation Complications

    Complications arising during the early post-intubation phase

    Measured: Within 24-hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start22 Jul 2022
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412823
Sponsor's protocol ID
KAUJED
Acronym
NeuroHypoxia
Status last verified
Aug 2022
First submitted
5 Jun 2022
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bodily JB, Webb HR, Weiss SJ, Braude DA. Incidence and Duration of Continuously Measured Oxygen Desaturation During Emergency Department Intubation. Ann Emerg Med. 2016 Mar;67(3):389-95. doi: 10.1016/j.annemergmed.2015.06.006. Epub 2015 Jul 9.

    PubMed 26164643

  • Gebremedhn EG, Mesele D, Aemero D, Alemu E. The incidence of oxygen desaturation during rapid sequence induction and intubation. World J Emerg Med. 2014;5(4):279-85. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.007.

    PubMed 25548602

  • Okubo M, Gibo K, Hagiwara Y, Nakayama Y, Hasegawa K; Japanese Emergency Medicine Network Investigators. The effectiveness of rapid sequence intubation (RSI) versus non-RSI in emergency department: an analysis of multicenter prospective observational study. Int J Emerg Med. 2017 Dec;10(1):1. doi: 10.1186/s12245-017-0129-8. Epub 2017 Jan 25.

    PubMed 28124199

  • Tan E, Loubani O, Kureshi N, Green RS. Does apneic oxygenation prevent desaturation during emergency airway management? A systematic review and meta-analysis. Can J Anaesth. 2018 Aug;65(8):936-949. doi: 10.1007/s12630-018-1124-0. Epub 2018 Apr 23.

    PubMed 29687359

  • Pourmand A, Robinson C, Dorwart K, O'Connell F. Pre-oxygenation: Implications in emergency airway management. Am J Emerg Med. 2017 Aug;35(8):1177-1183. doi: 10.1016/j.ajem.2017.06.006. Epub 2017 Jun 8.

    PubMed 28623005

  • Lacerte M, Hays Shapshak A, Mesfin FB. Hypoxic Brain Injury. 2023 Jan 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537310/

    PubMed 30725995

  • Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 1993 Feb;34(2):216-22. doi: 10.1097/00005373-199302000-00006.

    PubMed 8459458

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation Complication, run by King Abdulaziz University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abdullah Bakhsh (+966 555080287, aarbakhsh@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (mRs) (time frame: Up to 30-days of intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412823, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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