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Hyperoxygenation in Anesthetized Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02384616
Acronym
OXPED
Enrollment
58
Registered
2015-03-10
Start date
2015-05-31
Completion date
2018-06-30
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperoxia

Keywords

Lung Volume Measurements, airway resistance, general anesthesia

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.

Interventions

OTHEROxygen

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

Sponsors

Walid HABRE
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen24 hoursMeasurement 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 oxygen24 hoursMeasurement of airway resistance and respiratory system elastance by forced oscillation technique

Secondary

MeasureTime frameDescription
Respiratory complications1 monthAssessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications
Postoperative nausea and vomiting24 hours

Other

MeasureTime frame
Surgical site infection1 month

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026