NCT02698020

Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Oxygen Toxicity
• Oxidative Stress

Interventions

Type	Name	Description
PROCEDURE	Room-air	Provision of room-air

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-07-30
• Completion: 2018-10-10
• First posted: 2016-03-03
• Last updated: 2018-10-15

Locations

1 site across 1 country: Sweden