NCT04020900

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1 day

First QC Date

July 15, 2019

Last Update Submit

July 15, 2019

Conditions

Keywords

ChildrenRespiratory

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Children <18 years, admitted for a general anesthesia.

Children \<18 years, admitted for a general anesthesia.

Other: Respiratory management

Interventions

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

Children <18 years, admitted for a general anesthesia.

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children \< 18 years of age, admitted for a general anaesthesia

You may qualify if:

  • Children less than 18 years of age
  • Admitted in one of the participating centers
  • over 2 days (21 and 22 June 2017)

You may not qualify if:

  • Children extracorporeal circulation
  • Opposition of the parents or legal guardians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Florent BAUDIN, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 16, 2019

Study Start

June 21, 2017

Primary Completion

June 22, 2017

Study Completion

September 30, 2017

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations