Neurologic Function Post Intubation

NCT05412823 | Recruiting DMC

• 1 other identifier: KAUJED
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Intubation Complication

Keywords

Emergency Intubation; Hypoxia; Neurologic Function

Outcome Measures

Primary Outcomes (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.

  Up to 30-days of intubation

Secondary Outcomes (5)

• In-hospital Mortality

  Up to 30-days of intubation

• ICU Length of Stay

  Up to 30-days from intubation

• Hospital Length of Stay

  Up to 30-days of intubation

• Incidence of Aspiration

  Up to 14-days of intubation

• Post-Intubation Complications

  Within 24-hours

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adults requiring emergency intubation based on the treating clinician

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

RECRUITING

Related Publications (7)

• 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.

  PMID: 26164643 BACKGROUND

• 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.

  PMID: 25548602 BACKGROUND

• 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.

  PMID: 28124199 BACKGROUND

• 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.

  PMID: 29687359 BACKGROUND

• 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.

  PMID: 28623005 BACKGROUND

• 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/

  PMID: 30725995 BACKGROUND

• 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.

  PMID: 8459458 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abdullah Bakhsh

CONTACT

+966 555080287; aarbakhsh@kau.edu.sa

Asseil Bossei

CONTACT

+966 551500666; asseil.a.b.95@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 9, 2022
• Study Start: July 22, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

SA (1)