Neurologic Function Post Intubation

NCT ID: NCT05412823

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-22

Study Completion Date

2027-08-01

Brief Summary

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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

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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.

Conditions

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Intubation Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypoxic group

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

No interventions assigned to this group

Non-hypoxic group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Abdullah Bakhsh

Assistant Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Abdulaziz University Hospital

Jeddah, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Abdullah Bakhsh

Role: CONTACT

+966 555080287

Asseil Bossei

Role: CONTACT

+966 551500666

Facility Contacts

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Abdullah Bakhsh

Role: primary

+966 555080287

References

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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.

Reference Type BACKGROUND
PMID: 26164643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25548602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28124199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29687359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28623005 (View on PubMed)

Lacerte M, Hays Shapshak A, Mesfin FB. Hypoxic Brain Injury. 2023 Jan 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537310/

Reference Type BACKGROUND
PMID: 30725995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8459458 (View on PubMed)

Other Identifiers

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KAUJED

Identifier Type: -

Identifier Source: org_study_id

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