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NCT04020900 Clinical Trial

Respiratory Management of Children Under Anaesthesia

Anesthesia Clinical Trial

— PEDIAVENT  

Official title:
Respiratory Management of Children Under Anaesthesia: a French Prospective Multicentre Observational Study

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date July 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Respiratory management
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

Locations
Country Name City State
France Hôpital Femme Mère Enfant Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
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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