Optimized Oxygen Delivery During General Anesthesia in Newborn Infants
Overview
An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.
Full Title of Study: “Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 30, 2018
Detailed Description
Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.
Interventions
- Procedure: Room-air
- Provision of room-air
Arms, Groups and Cohorts
- No Intervention: Control
- High level of supplemental inspired oxygen
- Experimental: Room-air
- Supplemental oxygen only provided if oxygen saturation below target
Clinical Trial Outcome Measures
Primary Measures
- Transcutaneous and blood-gas pO2
- Time Frame: 30 min
- Area under curve (AUC) and absolute values of pO2
Secondary Measures
- Cerebral Oximetry
- Time Frame: 30 min
- AUC of O2 saturation
- Atelectasis
- Time Frame: 30 min
- Reduced lung compliance as a measure of atelectasis formation
- Isoprostane
- Time Frame: 4 h
- Level of isoprostanes in blood and urine
Participating in This Clinical Trial
1. Newborn less than 44 weeks postconceptional age 2. No pulmonary disease, no oxygen requirement, or assisted ventilation 3. No genetic syndrome
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 4 Weeks
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Uppsala University
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Johan Agren, MD, PhD, Principal Investigator, Department of Women’s and Children’s Health, Uppsala University
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