Apneic Oxygenation in the Pediatric Intensive Care Unit



Status:Recruiting
Healthy:No
Age Range:Any - 17
Updated:1/26/2019
Start Date:December 23, 2017
End Date:December 31, 2019
Contact:Fasiha M Saeed, MD
Email:fasiha.saeed@advocatehealth.com
Phone:847-723-5578

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
1775 West Dempster Street
Park Ridge, Illinois 60068
(847) 723-2210
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials