Optimized Oxygen Delivery During General Anesthesia in Newborn Infants (ANOXneo)

Uppsala University

Status: Completed

Conditions: Oxygen Toxicity; Oxidative Stress

Treatments: Procedure: Room-air

Study type: Interventional

Funder types: Other

Identifiers

NCT02698020

ANOXneo

Details and patient eligibility

About

An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: Under 4 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Newborn less than 44 weeks postconceptional age
2. No pulmonary disease, no oxygen requirement, or assisted ventilation
3. No genetic syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Control

No Intervention group

Description:

High level of supplemental inspired oxygen

Room-air

Experimental group

Description:

Supplemental oxygen only provided if oxygen saturation below target

Treatment:

Procedure: Room-air