Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

Oxidative Stress Clinical Trial

— ANOXneo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698020
• Other study ID #: ANOXneo
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 10, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

1. Newborn less than 44 weeks postconceptional age

2. No pulmonary disease, no oxygen requirement, or assisted ventilation

3. No genetic syndrome

Related Conditions & MeSH terms

• Oxidative Stress
• Oxygen Toxicity

Intervention

Procedure:
• Room-air
Provision of room-air

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital, Pediatric anesthesia Unit	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcutaneous and blood-gas pO2	Area under curve (AUC) and absolute values of pO2	30 min
Secondary	Cerebral Oximetry	AUC of O2 saturation	30 min
Secondary	Atelectasis	Reduced lung compliance as a measure of atelectasis formation	30 min
Secondary	Isoprostane	Level of isoprostanes in blood and urine	4 h