Anesthesia Clinical Trial
— PEDIAVENTOfficial title:
Respiratory Management of Children Under Anaesthesia: a French Prospective Multicentre Observational Study
NCT number | NCT04020900 |
Other study ID # | Pediavent |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 21, 2017 |
Est. completion date | September 30, 2017 |
Verified date | July 2019 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 701 |
Est. completion date | September 30, 2017 |
Est. primary completion date | June 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility |
Inclusion Criteria: - Children less than 18 years of age - Admitted in one of the participating centers - over 2 days (21 and 22 June 2017) Exclusion Criteria: - Children extracorporeal circulation - Children who required ventilation with lung exclusion - Opposition of the parents or legal guardians |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Femme Mère Enfant | Bron |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | up to 1 hour (during a stable period in anaesthesia) |
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