Clinical Trial: Hyperoxygenation in Anesthetized Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Impact of Intraoperative High Inspired OXygen Fraction on Pulmonary Function, Surgical Site Infection, Postoperative Nausea and Vomiting in PEDiatric Anesthesia, the OXPED Study

Brief Summary: This study is aiming at assessing the effect of inspired oxygen fraction during general anesthesia on children's lung mechanics and volume. More specifically, the temporal change in end-expiratory lung volume (EELV) and respiratory system resistance and elastance during the perioperative period will be characterized in order to define the the effect of high inspired fraction of oxygen on lung function.

Detailed Summary:

High-enriched oxygen fractions (FiO2)are common practice during general anesthesia both to ensure normoxemia despite intrapulmonary shunts and to provide security in case of adverse events. However, high-inspired oxygen fraction may decrease ventilation-perfusion ratios and its benefits are still unproven in children.

The investigators aim at assessing the benefits and potential adverse effects of high-inspired oxygen fraction in two groups of children receiving either 30% FiO2 or 80% FiO2 during maintenance of anesthesia. Nitrogen multiple breath washout technique and forced oscillation technique will be used to measure end-expiratory lung volume (EELV) and airway resistance (Rrs) and respiratory elastance (Xrs) respectively. These measurements will be obtained before the general anesthesia, one hour and one day after the procedure.

Sponsor: Walid HABRE

Current Primary Outcome:

• Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen [ Time Frame: 24 hours ]
  Measurement of end-expiratory lung volume by nitrogen wash-out technique
• Postoperative changes in airway resistance in children receiving low (35%) or high (80%) intraoperative fraction of oxygen [ Time Frame: 24 hours ]
  Measurement of airway resistance and respiratory system elastance by forced oscillation technique

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Respiratory complications [ Time Frame: 1 month ]
  Assessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications
• Postoperative nausea and vomiting [ Time Frame: 24 hours ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: February 17, 2015
Date Started: May 2015
Date Completion: June 2017
Last Updated: October 30, 2016
Last Verified: October 2016