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Clinical Trials/NCT02384616
NCT02384616
Completed
Not Applicable

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

Walid HABRE1 site in 1 country58 target enrollmentMay 2015
ConditionsHyperoxia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperoxia
Sponsor
Walid HABRE
Enrollment
58
Locations
1
Primary Endpoint
Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
Status
Completed
Last Updated
7 years ago

Overview

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 Description

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
June 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Walid HABRE
Responsible Party
Sponsor Investigator
Principal Investigator

Walid HABRE

Associate Professor

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiology (ASA) physical status I and II
  • Body mass index \< 30 kg/m2
  • Scheduled for elective surgery in the supine position lasting \< 200 min
  • General Anesthesia with tracheal intubation

Exclusion Criteria

  • Patients hospitalized more than 24 h before the operation
  • History or clinical signs of heart or lung disease
  • Upper respiratory tract infection \< 2 weeks prior to surgery
  • Predictable difficult airway
  • History of apnea
  • Abdominal or thoracic surgery
  • Lack of cooperation, language barrier

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Respiratory complications(1 month)
  • Postoperative nausea and vomiting(24 hours)

Study Sites (1)

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