An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Provision of room-air
Uppsala University Hospital, Pediatric anesthesia Unit
Uppsala, Sweden
Transcutaneous and blood-gas pO2
Area under curve (AUC) and absolute values of pO2
Time frame: 30 min
Cerebral Oximetry
AUC of O2 saturation
Time frame: 30 min
Atelectasis
Reduced lung compliance as a measure of atelectasis formation
Time frame: 30 min
Isoprostane
Level of isoprostanes in blood and urine
Time frame: 4 h
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