Clinical trial NCT02384616: Hyperoxygenation in Anesthetized Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperoxia
Keywords: Lung Volume Measurements
airway resistance
general anesthesia
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 58
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
timeFrame: 24 hours
measure: Postoperative changes in airway resistance in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
timeFrame: 24 hours
Secondary outcomes:
measure: Respiratory complications
timeFrame: 1 month
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
Other outcomes:
measure: Surgical site infection
timeFrame: 1 month
Locations:
city: Geneva
country: Switzerland
facility: Geneva Children's Hospital, Pediatric Anesthesia Unit
Study officials:
affiliation: Geneva Children's Hospital, University Hospitals of Geneva
name: Walid Habre, MD, PhD
role: STUDY_DIRECTOR
affiliation: Geneva Children's Hospital, University Hospitals of Geneva
name: Beatrice de la Grandville
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals of Geneva
name: Sam Bayat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grandville B, Petak F, Albu G, Bayat S, Pichon I, Habre W. High inspired oxygen fraction impairs lung volume and ventilation heterogeneity in healthy children: a double-blind randomised controlled trial. Br J Anaesth. 2019 May;122(5):682-691. doi: 10.1016/j.bja.2019.01.036. Epub 2019 Mar 11.