HyperoxiaOXPEDNCT02384616
Hyperoxygenation in Anesthetized Children
A study testing Oxygen in people with Hyperoxia, run by Walid HABRE at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperoxia
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva Children's Hospital, Pediatric Anesthesia Unit
Geneva, 1205
About this study
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
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.
Read the 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.
- Conditions
- Hyperoxia
- Being tested
- Oxygen
- Keywords
- Lung Volume Measurements, airway resistance, general anesthesia
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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%. Receives: Other: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 hours
Secondary outcomes (2)
Respiratory complications
Assessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications
Measured: 1 month
Postoperative nausea and vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid HABRE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walid HABRE, University Hospital, Geneva
- Investigators
- Walid Habre, MD, PhD, Study director, Geneva Children's Hospital, University Hospitals of GenevaBeatrice de la Grandville, Principal investigator, Geneva Children's Hospital, University Hospitals of GenevaSam Bayat, MD, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384616
- Sponsor's protocol ID
- CER 14-039
- Acronym
- OXPED
- Status last verified
- Aug 2018
- First submitted
- 17 Feb 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30916028
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02384616
- Acronym / sponsor ID
- OXPED / CER 14-039
- Conditions
- Hyperoxia
- Keywords
- Lung Volume Measurements, airway resistance, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Walid HABREUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group High FiO2 | Active comparator | Other: OxygenChildren 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%. |
| Group Low FiO2 | Active comparator | Other: OxygenChildren 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%. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenDelivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia. | Other | Group High FiO2, Group Low FiO2 |
Primary outcome
Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
Time frame: 24 hours
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
Time frame: 24 hours
Measurement of airway resistance and respiratory system elastance by forced oscillation technique
2 secondary outcomes
Respiratory complications
Time frame: 1 month
Postoperative nausea and vomiting
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 30916028Grandville 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walid Habre, MD, PhD study director
Geneva Children's Hospital, University Hospitals of Geneva
Beatrice de la Grandville principal investigator
Geneva Children's Hospital, University Hospitals of Geneva
Sam Bayat, MD principal investigator
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Hyperoxia, run by Walid HABRE at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.