Oxidative Stress, Oxygen Toxicity
Conditions
Keywords
Newborn, Anesthesia, Oxygen, Hyperoxia
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.
Interventions
PROCEDURERoom-air
Provision of room-air
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Weeks
Healthy volunteers
No
Inclusion criteria
1. Newborn less than 44 weeks postconceptional age 2. No pulmonary disease, no oxygen requirement, or assisted ventilation 3. No genetic syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous and blood-gas pO2 | 30 min | Area under curve (AUC) and absolute values of pO2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Oximetry | 30 min | AUC of O2 saturation |
| Atelectasis | 30 min | Reduced lung compliance as a measure of atelectasis formation |
| Isoprostane | 4 h | Level of isoprostanes in blood and urine |
Countries
Sweden
Outcome results
None listed