Optimized Oxygen Delivery During General Anesthesia in Newborn Infants
- Conditions
- Oxygen ToxicityOxidative Stress
- Interventions
- Procedure: Room-air
- Registration Number
- NCT02698020
- Lead Sponsor
- Uppsala University
- Brief Summary
An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Room-air Room-air Supplemental oxygen only provided if oxygen saturation below target
- Primary Outcome Measures
Name Time Method Transcutaneous and blood-gas pO2 30 min Area under curve (AUC) and absolute values of pO2
- Secondary Outcome Measures
Name Time Method Cerebral Oximetry 30 min AUC of O2 saturation
Isoprostane 4 h Level of isoprostanes in blood and urine
Atelectasis 30 min Reduced lung compliance as a measure of atelectasis formation
Trial Locations
- Locations (1)
Uppsala University Hospital, Pediatric anesthesia Unit
🇸🇪Uppsala, Sweden