NCT02384616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

February 17, 2015

Last Update Submit

August 6, 2018

Conditions

Hyperoxia

Keywords

Lung Volume Measurementsairway resistancegeneral anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Respiratory complications

    1 month

  • Postoperative nausea and vomiting

    24 hours

Other Outcomes (1)

  • Surgical site infection

    1 month

Study Arms (2)

Group High FiO2

ACTIVE COMPARATOR

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%.

Other: Oxygen

Group Low FiO2

ACTIVE COMPARATOR

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%.

Other: Oxygen

Interventions

OxygenOTHER

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

Group High FiO2Group Low FiO2

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva Children's Hospital, Pediatric Anesthesia Unit

Geneva, 1205, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 30916028DERIVED

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Walid Habre, MD, PhD

    Geneva Children's Hospital, University Hospitals of Geneva

    STUDY DIRECTOR

  • Beatrice de la Grandville

    Geneva Children's Hospital, University Hospitals of Geneva

    PRINCIPAL INVESTIGATOR

  • Sam Bayat, MD

    University Hospitals of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 10, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

CH(1)