Apneic Oxygenation in the Pediatric Intensive Care Unit

NCT03374046 | Completed DMC

• 1 other identifier: K5900309
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the impact of apneic oxygenation on the time to desaturation in pediatric patients treated in a pediatric intensive care unit (PICU). The investigators hypothesize pediatric patients will have an increase in time to desaturation with apneic oxygenation when compared to standard practice in the PICU.

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Time to desaturation

  To evaluate the effect of apneic oxygenation in time to desaturation (\>/= 5% points from baseline O2 saturation) from the onset of apnea during intubation attempts in the PICU

  Only during intubation

Secondary Outcomes (1)

• Number of Intubation Attempts

  Only during intubation

Study Arms (2)

Control Group

NO INTERVENTION

Standard care

Apneic Oxygenation Group

EXPERIMENTAL

During apneic period of intubation attempt, patient will be placed on nasal cannula * If 0-2 years: 3L/min NC of 100% FiO2 * If \> or = to 2 through17 years: 5L/min NC of 100% FiO2

Procedure: Apneic Oxygenation

Interventions

Apneic Oxygenation PROCEDURE

Supplemental oxygen will be provided via nasal cannula during intubation attempt

Apneic Oxygenation Group

Eligibility Criteria

• Age: 0 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Treated in the PICU at ACH-PR
• Age 0 through17 years
• Indication for emergent intubation
• Premedication with a paralytic agent resulting in apnea

You may not qualify if:

• No paralytic agent used
• Elective intubations
• Presence of cyanotic heart disease
• Inability to safely place nasal cannula on patient
• Nasal intubation
• Patients already enrolled in the study (prior intubation)
• Inability to randomize due to urgency of intubation
• Females who are known to be pregnant

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Related Publications (4)

• Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.

  PMID: 22050948 BACKGROUND

• Taha SK, Siddik-Sayyid SM, El-Khatib MF, Dagher CM, Hakki MA, Baraka AS. Nasopharyngeal oxygen insufflation following pre-oxygenation using the four deep breath technique. Anaesthesia. 2006 May;61(5):427-30. doi: 10.1111/j.1365-2044.2006.04610.x.

  PMID: 16674614 BACKGROUND

• Wimalasena Y, Burns B, Reid C, Ware S, Habig K. Apneic oxygenation was associated with decreased desaturation rates during rapid sequence intubation by an Australian helicopter emergency medicine service. Ann Emerg Med. 2015 Apr;65(4):371-6. doi: 10.1016/j.annemergmed.2014.11.014. Epub 2014 Dec 20.

  PMID: 25536868 BACKGROUND

• Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.

  PMID: 20400000 BACKGROUND

Study Officials

• Fasiha Saeed, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: December 15, 2017
• Study Start: December 23, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)