Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Transcutaneous and blood-gas pO2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 4 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newborn less than 44 weeks postconceptional age
- •No pulmonary disease, no oxygen requirement, or assisted ventilation
- •No genetic syndrome
Exclusion Criteria
- Not provided
Arms & Interventions
Control
High level of supplemental inspired oxygen
Room-air
Supplemental oxygen only provided if oxygen saturation below target
Intervention: Room-air (Procedure)
Outcomes
Primary Outcomes
Transcutaneous and blood-gas pO2
Time Frame: 30 min
Area under curve (AUC) and absolute values of pO2
Secondary Outcomes
- Cerebral Oximetry(30 min)
- Isoprostane(4 h)
- Atelectasis(30 min)