Hyperoxygenation in Anesthetized Children

Not Applicable

Completed

• Conditions: Hyperoxia
• Interventions: Other: Oxygen

• Registration Number: NCT02384616
• Lead Sponsor: Walid HABRE

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 Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-10
• Study Start: 2015-05
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Low FiO2	Oxygen	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%.
Group High FiO2	Oxygen	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%.

Primary Outcome Measures

Name	Time	Method
Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen	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	24 hours	Measurement of airway resistance and respiratory system elastance by forced oscillation technique

Secondary Outcome Measures

Name	Time	Method
Respiratory complications	1 month	Assessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications
Postoperative nausea and vomiting	24 hours

Trial Locations

Locations (1)

Geneva Children's Hospital, Pediatric Anesthesia Unit; 🇨🇭 Geneva, Switzerland