Neurologic Function Post Intubation

Intubation Complication Clinical Trial

— NeuroHypoxia  

Official title:

Post Intubation Neurologic Outcomes in Critically Ill Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412823
• Other study ID #: KAUJED
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Intubation Complication

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