AnesthesiaPROVENTIPEDNCT03901599
Protective Ventilation Based on Alveolar Ventilation in Children
An observational study of Anesthesia and Peroperative Complication, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Anesthesia, Peroperative Complication
- What is being tested?
- Alveolar ventilation monitoring estimated by the capnographic ventilation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2019to 27 Oct 2019
- Phase
- Observational
- 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 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under general anaesthesia
Who may be able to join
- Children aged < 12 and
- Weight between 5 and 40kg
- General anesthesia
- Non-opposition of parents or legal guardians
Who cannot join
- History of bronchodysplasia or laryngo tracheo malacia, cyanotic heart disease or neuromuscular disease
- Airleaks > 10%
- Bronchospasm during anesthesia
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69500
About this study
Official title: Feasibility of Protective Ventilation Based on the Alveolar Ventilation in Paediatric Anaesthesiology and Intensive Care.
Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. Therefore, it is difficult to propose an "optimal" tidal volume for all children. The objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. The hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.
- Conditions
- Anesthesia, Peroperative Complication
- Being tested
- Alveolar ventilation monitoring estimated by the capnographic ventilation
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ventilation monitoring estimated by the capnographic ventilationOther
Children are monitored using end-tidal CO2, Transcutaneous CO2 and volumetric capnographic. Respiratory rate is set using textbooks and guidelines (pediatric advanced life support). The physician in charge adapts the volume to target a CO2 between 38 and 42 mmHg. Data are recorded after a stabilization period of at least 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Children between 5-10Kg | Children with a body weight between 5-10Kg Receives: Other: Alveolar ventilation monitoring estimated by the capnographic ventilation | |
| Children between 10-20Kg | Children with a body weight between 10-20Kg Receives: Other: Alveolar ventilation monitoring estimated by the capnographic ventilation | |
| Children between 20-40Kg | Children with a body weight between 20-40Kg Receives: Other: Alveolar ventilation monitoring estimated by the capnographic ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of target alveolar minute volume to maintain normocapnia in children without mechanical ventilation.
The minute alveolar ventilation estimated by the volumetric capnography reported to the ideal body weight based on 100 breaths (expressed in ml/Kg/min).
Measured: 5 minutes after hemodynamic and ventilatory stabilization period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start16 May 2019
- Primary completion27 Oct 2019
- Study completion27 Oct 2019
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901599
- Sponsor's protocol ID
- 69HCL19_0114
- Acronym
- PROVENTIPED
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gardon A, De Queiroz Siqueira M, Cerceuil E, Bouhamri N, Chassard D, Baudin F. Alveolar target ventilation and dead space in children under anaesthesia: The proventiped cohort study. Eur J Anaesthesiol. 2023 Jul 1;40(7):495-500. doi: 10.1097/EJA.0000000000001832. Epub 2023 Apr 12.
PubMed 37052073
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Protective Ventilation Based on the Alveolar Ventilation in Paediatric Anaesthesiology and Intensive Care.
- ClinicalTrials.gov ID
- NCT03901599
- Acronym / sponsor ID
- PROVENTIPED / 69HCL19_0114
- Conditions
- Anesthesia, Peroperative Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 27 Oct 2019 (actual)
- Study completion
- 27 Oct 2019 (actual)
- First posted
- 3 Apr 2019 (actual)
- 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.
Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. Therefore, it is difficult to propose an "optimal" tidal volume for all children. The objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. The hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children between 5-10Kg | – | Other: Alveolar ventilation monitoring estimated by the capnographic ventilationChildren with a body weight between 5-10Kg |
| Children between 10-20Kg | – | Other: Alveolar ventilation monitoring estimated by the capnographic ventilationChildren with a body weight between 10-20Kg |
| Children between 20-40Kg | – | Other: Alveolar ventilation monitoring estimated by the capnographic ventilationChildren with a body weight between 20-40Kg |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under general anaesthesia
Key inclusion criteria (4 listed)
- Children aged < 12 and
- Weight between 5 and 40kg
- General anesthesia
- Non-opposition of parents or legal guardians
Key exclusion criteria (3 listed)
- History of bronchodysplasia or laryngo tracheo malacia, cyanotic heart disease or neuromuscular disease
- Airleaks > 10%
- Bronchospasm during anesthesia
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 |
|---|---|---|
| Alveolar ventilation monitoring estimated by the capnographic ventilationChildren are monitored using end-tidal CO2, Transcutaneous CO2 and volumetric capnographic. Respiratory rate is set using textbooks and guidelines (pediatric advanced life support). The physician in charge adapts the volume to target a CO2 between 38 and 42 mmHg. Data are recorded after a stabilization period of at least 5 minutes. | Other | Children between 10-20Kg, Children between 20-40Kg, Children between 5-10Kg |
Primary outcome
Determination of target alveolar minute volume to maintain normocapnia in children without mechanical ventilation.
Time frame: 5 minutes after hemodynamic and ventilatory stabilization period
The minute alveolar ventilation estimated by the volumetric capnography reported to the ideal body weight based on 100 breaths (expressed in ml/Kg/min).
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 4 Sep 2025.
- Results publication: PubMed 37052073Gardon A, De Queiroz Siqueira M, Cerceuil E, Bouhamri N, Chassard D, Baudin F. Alveolar target ventilation and dead space in children under anaesthesia: The proventiped cohort study. Eur J Anaesthesiol. 2023 Jul 1;40(7):495-500. doi: 10.1097/EJA.0000000000001832. Epub 2023 Apr 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Peroperative Complication, run by Hospices Civils de Lyon at 1 site in France.
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 3 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 4 Sep 2025. 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 France. 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?
Determination of target alveolar minute volume to maintain normocapnia in children without mechanical ventilation. (time frame: 5 minutes after hemodynamic and ventilatory stabilization period). 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 NCT03901599, 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 4 Sep 2025.