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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05412823
Other study ID # KAUJED
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 22, 2022
Est. completion date August 1, 2027

Study information

Verified date August 2022
Source King Abdulaziz University
Contact Abdullah Bakhsh
Phone +966 555080287
Email aarbakhsh@kau.edu.sa
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 1, 2027
Est. primary completion date June 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Saudi Arabia King Abdulaziz University Hospital Jeddah

Sponsors (1)

Lead Sponsor Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Lacerte M, Hays Shapshak A, Mesfin FB. Hypoxic Brain Injury. 2022 May 2. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537310/ — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 In-hospital Mortality Death during hospital stay Up to 30-days of intubation
Secondary ICU Length of Stay Duration of stay in intensive care unit Up to 30-days from intubation
Secondary Hospital Length of Stay Duration of stay in hospital Up to 30-days of intubation
Secondary Incidence of Aspiration Pulmonary aspiration confirmed by chest X-ray or chest CT Up to 14-days of intubation
Secondary Post-Intubation Complications Complications arising during the early post-intubation phase Within 24-hours
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