Hyperoxygenation in Anesthetized Children (OXPED)
Primary Purpose
Hyperoxia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional basic science trial for Hyperoxia focused on measuring Lung Volume Measurements, airway resistance, general anesthesia
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
Sites / Locations
- Geneva Children's Hospital, Pediatric Anesthesia Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group High FiO2
Group Low FiO2
Arm Description
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%.
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%.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Respiratory complications
Assessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications
Postoperative nausea and vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02384616
Brief Title
Hyperoxygenation in Anesthetized Children
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Walid HABRE
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxia
Keywords
Lung Volume Measurements, airway resistance, general anesthesia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group High FiO2
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Group Low FiO2
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.
Primary Outcome Measure Information:
Title
Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
Description
Measurement of end-expiratory lung volume by nitrogen wash-out technique
Time Frame
24 hours
Title
Postoperative changes in airway resistance in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
Description
Measurement of airway resistance and respiratory system elastance by forced oscillation technique
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Respiratory complications
Description
Assessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications
Time Frame
1 month
Title
Postoperative nausea and vomiting
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Surgical site infection
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Habre, MD, PhD
Organizational Affiliation
Geneva Children's Hospital, University Hospitals of Geneva
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Beatrice de la Grandville
Organizational Affiliation
Geneva Children's Hospital, University Hospitals of Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam Bayat, MD
Organizational Affiliation
University Hospitals of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva Children's Hospital, Pediatric Anesthesia Unit
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30916028
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.
Results Reference
derived
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Hyperoxygenation in Anesthetized Children
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