Hyperoxygenation in Anesthetized Children

Hyperoxia Clinical Trial

— OXPED  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384616
• Other study ID #: CER 14-039
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxia
• Postoperative Nausea and Vomiting

Intervention

Other:
• Oxygen
Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.

Locations

Country	Name	City	State
Switzerland	Geneva Children's Hospital, Pediatric Anesthesia Unit	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Walid HABRE

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical site infection		1 month
Primary	Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen	Measurement of end-expiratory lung volume by nitrogen wash-out technique	24 hours
Primary	Postoperative changes in airway resistance in children receiving low (35%) or high (80%) intraoperative fraction of oxygen	Measurement of airway resistance and respiratory system elastance by forced oscillation technique	24 hours
Secondary	Respiratory complications	Assessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications	1 month
Secondary	Postoperative nausea and vomiting		24 hours