Protective Ventilation Based on Alveolar Ventilation in Children

Completed

• Conditions: Peroperative Complication; Anesthesia
• Interventions: Other: Alveolar ventilation monitoring estimated by the capnographic ventilation

• Registration Number: NCT03901599
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2019-05-16
• Primary Completion: 2019-10-27
• Study Completion: 2019-10-27
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children aged < 12 and
• Weight between 5 and 40kg
• General anesthesia
• Non-opposition of parents or legal guardians

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Exclusion Criteria

• History of bronchodysplasia or laryngo tracheo malacia, cyanotic heart disease or neuromuscular disease
• Airleaks > 10%
• Bronchospasm during anesthesia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children between 20-40Kg	Alveolar ventilation monitoring estimated by the capnographic ventilation	Children with a body weight between 20-40Kg
Children between 5-10Kg	Alveolar ventilation monitoring estimated by the capnographic ventilation	Children with a body weight between 5-10Kg
Children between 10-20Kg	Alveolar ventilation monitoring estimated by the capnographic ventilation	Children with a body weight between 10-20Kg

Primary Outcome Measures

Name	Time	Method
Determination of target alveolar minute volume to maintain normocapnia in children without mechanical ventilation.	5 minutes after hemodynamic and ventilatory stabilization period	The minute alveolar ventilation estimated by the volumetric capnography reported to the ideal body weight based on 100 breaths (expressed in ml/Kg/min).

Trial Locations

Locations (1)

Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon; 🇫🇷 Bron, France