AnesthesiaPEDIAVENTNCT04020900
Respiratory Management of Children Under Anaesthesia
An observational study of Anesthesia and Peroperative Complication, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Ventilation management in paediatric anaesthesia remains difficult because of the wide range of age and weight, and therefore practices are heterogeneous. In adults, protective ventilation during anesthesia is now a standard of care but in children there is no level of evidence to recommend it. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Anesthesia, Peroperative Complication
- What is being tested?
- Respiratory management
- How many people
- 701 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2017to 30 Sep 2017
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children < 18 years of age, admitted for a general anaesthesia
Who may be able to join
- Children less than 18 years of age
- Admitted in one of the participating centers
- over 2 days (21 and 22 June 2017)
Who cannot join
- Children extracorporeal circulation
- Children who required ventilation with lung exclusion
- Opposition of the parents or legal guardians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Management of Children Under Anaesthesia: a French Prospective Multicentre Observational Study
Ventilation management in paediatric anaesthesia remains difficult because of the wide range of age and weight, and therefore practices are heterogeneous. In adults, protective ventilation during anesthesia is now a standard of care but in children there is no level of evidence to recommend it. The aim of the study was to describe current practice and the factors associated with the use of high tidal volume during anaesthesia in children in France.
- Conditions
- Anesthesia, Peroperative Complication
- Being tested
- Respiratory management
- Keywords
- Children, Respiratory
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory managementOther
Data on respiratory management were collected at different time: data regarding the induction period, ventilatory parameters set and measured during a stable period, ventilatory change made during anaesthesia, use of recruitment manoeuvres, data regarding weaning and extubation
| Study group | Role | What they receive |
|---|---|---|
| Children <18 years, admitted for a general anesthesia. | Children <18 years, admitted for a general anesthesia. Receives: Other: Respiratory management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight
Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight
Measured: up to 1 hour (during a stable period in anaesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start21 Jun 2017
- Primary completion22 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent BAUDIN, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020900
- Sponsor's protocol ID
- Pediavent
- Acronym
- PEDIAVENT
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Management of Children Under Anaesthesia: a French Prospective Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT04020900
- Acronym / sponsor ID
- PEDIAVENT / Pediavent
- Conditions
- Anesthesia, Peroperative Complication
- Keywords
- Children, Respiratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 16 Jul 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.
Ventilation management in paediatric anaesthesia remains difficult because of the wide range of age and weight, and therefore practices are heterogeneous. In adults, protective ventilation during anesthesia is now a standard of care but in children there is no level of evidence to recommend it. The aim of the study was to describe current practice and the factors associated with the use of high tidal volume during anaesthesia in children in France.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children <18 years, admitted for a general anesthesia. | – | Other: Respiratory managementChildren <18 years, admitted for a general anesthesia. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children < 18 years of age, admitted for a general anaesthesia
Key inclusion criteria (3 listed)
- Children less than 18 years of age
- Admitted in one of the participating centers
- over 2 days (21 and 22 June 2017)
Key exclusion criteria (3 listed)
- Children extracorporeal circulation
- Children who required ventilation with lung exclusion
- Opposition of the parents or legal guardians
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 |
|---|---|---|
| Respiratory managementData on respiratory management were collected at different time: data regarding the induction period, ventilatory parameters set and measured during a stable period, ventilatory change made during anaesthesia, use of recruitment manoeuvres, data regarding weaning and extubation | Other | Children <18 years, admitted for a general anesthesia. |
Primary outcome
Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight
Time frame: up to 1 hour (during a stable period in anaesthesia)
Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight
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 16 Jul 2019.
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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.
Florent BAUDIN, MD principal investigator
Hospices Civils de Lyon
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 3 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 16 Jul 2019. 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?
Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight (time frame: up to 1 hour (during a stable period in anaesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2019.