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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03901599
Other study ID # 69HCL19_0114
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 16, 2019
Est. completion date October 27, 2019

Study information

Verified date January 2020
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 27, 2019
Est. primary completion date October 27, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Months to 12 Years
Eligibility Inclusion Criteria:

- Children aged < 12 and

- Weight between 5 and 40kg

- General anesthesia

- Non-opposition of parents or legal guardians

Exclusion Criteria:

- History of bronchodysplasia or laryngo tracheo malacia, cyanotic heart disease or neuromuscular disease

- Airleaks > 10%

- Bronchospasm during anesthesia

Study Design


Intervention

Other:
Alveolar ventilation monitoring estimated by the capnographic ventilation
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.

Locations

Country Name City State
France Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon 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 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). 5 minutes after hemodynamic and ventilatory stabilization period
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