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Apneic Oxygenation in the Pediatric Intensive Care Unit

Apneic Oxygenation in the Pediatric Intensive Care Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03374046
Enrollment
41
Registered
2017-12-15
Start date
2017-12-23
Completion date
2020-02-01
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

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.

Detailed description

Oxygen (O2) desaturation is one of the risks of intubation, especially in critically ill children with comorbidities, increased O2 consumption and decreased O2 delivery. Desaturation places patients at greater risk for dysrhythmia, hemodynamic instability, hypoxic brain injury, and death. As shown in the oxyhemoglobin dissociation curve, once oxyhemoglobin (PaO2) saturations drop to \ 90%, there is an increased risk for precipitous desaturation. Although many may believe there would be no gas exchange during apnea, alveoli continue to take up oxygen even without diaphragmatic movements or lung expansion. As such, the administration of oxygen during intubation (when a patient is apneic) has not been a standard practice until recently. Recent studies in adults have shown an increase in the time to desaturation when they are given concurrent oxygen administration during an intubation attempt. This use of oxygen during intubation is referred to as apneic oxygenation. As a result of this work, apneic oxygenation has become standard practice in many emergency departments, even with pediatric patients. Yet, in pediatric hospital units, including intensive care, this is not the standard practice and no pediatric studies have been published on this subject to date. In the study unit apneic oxygenation is not standard during intubation. The investigators would like to evaluate its use as it has shown benefits in prior research published on adults. Most patients in the PICU are already on a source of oxygen administration prior to intubation, this source of oxygen is usually removed during the intubation attempt, when the patient is apneic and not breathing on his/her own. Continuing oxygen administration during the apneic period, would be a minimal to no risk intervention and has only shown a benefit during the apneic period. For this protocol: Once a decision is made for intubation, the subject will be randomized into one of two groups: 1. Control (standard practice) 2. Apneic oxygenation. Randomization: Subjects will be stratified by age (0 - 2 years and \>2 - 17), randomized in blocks of 10 until the final sample size is achieved. For all subjects, the study protocol will determine only the provision of supplemental oxygen during intubation. Decisions regarding the intubation approach, pre-oxygenation, patient positioning, medications used, ventilation strategy, and choice of equipment will be made by the clinical team. Because of the nature of the study intervention, clinicians and study personnel will be aware of study group assignments after randomization.

Interventions

Supplemental oxygen will be provided via nasal cannula during intubation attempt

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Days to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Time to desaturationOnly during intubationTo 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

Secondary

MeasureTime frameDescription
Number of Intubation AttemptsOnly during intubationTo compare the number of intubation attempts prior to successful intubation between children treated with apneic oxygenation compared to standard care

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026