Impact of Intraoperative High Inspired OXygen Fraction on Pulmonary Function, Surgical Site Infection, Postoperative Nausea and Vomiting in PEDiatric Anesthesia, the OXPED Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group High FiO2
Children will receive Fi02 100% during induction of anesthesia until end tidal oxygen concentration (Et 02) of 90% before intubation, anesthesia will be maintained with Fi02 of 80%. Then, shortly before the planned extubation, Fi02 will be increased to 100%.
Intervention: Oxygen (Other)
Group Low FiO2
Children will receive Fi02 80% until Et 02 70% before intubation, anaesthesia will be maintained with Fi02 35%. Then, shortly before the planned extubation, Fi02 will be increased again to 80%.
Intervention: Oxygen (Other)
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)
Investigators
Walid HABRE
Associate Professor
University Hospital, Geneva