Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

Overview

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

Full Title of Study: “Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2018

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

  • Procedure: Room-air
    • Provision of room-air

Arms, Groups and Cohorts

  • No Intervention: Control
    • High level of supplemental inspired oxygen
  • Experimental: Room-air
    • Supplemental oxygen only provided if oxygen saturation below target

Clinical Trial Outcome Measures

Primary Measures

  • Transcutaneous and blood-gas pO2
    • Time Frame: 30 min
    • Area under curve (AUC) and absolute values of pO2

Secondary Measures

  • Cerebral Oximetry
    • Time Frame: 30 min
    • AUC of O2 saturation
  • Atelectasis
    • Time Frame: 30 min
    • Reduced lung compliance as a measure of atelectasis formation
  • Isoprostane
    • Time Frame: 4 h
    • Level of isoprostanes in blood and urine

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 4 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Uppsala University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johan Agren, MD, PhD, Principal Investigator, Department of Women’s and Children’s Health, Uppsala University

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