Protective Ventilation Based on Alveolar Ventilation in Children

NCT ID: NCT03901599

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-16

Study Completion Date

2019-10-27

Brief Summary

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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

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Conditions

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Anesthesia Peroperative Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children between 5-10Kg

Children with a body weight between 5-10Kg

Alveolar ventilation monitoring estimated by the capnographic ventilation

Intervention Type OTHER

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.

Children between 10-20Kg

Children with a body weight between 10-20Kg

Alveolar ventilation monitoring estimated by the capnographic ventilation

Intervention Type OTHER

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.

Children between 20-40Kg

Children with a body weight between 20-40Kg

Alveolar ventilation monitoring estimated by the capnographic ventilation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Bron, , France

Site Status

Countries

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France

References

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Gardon A, De Queiroz Siqueira M, Cerceuil E, Bouhamri N, Chassard D, Baudin F. Alveolar target ventilation and dead space in children under anaesthesia: The proventiped cohort study. Eur J Anaesthesiol. 2023 Jul 1;40(7):495-500. doi: 10.1097/EJA.0000000000001832. Epub 2023 Apr 12.

Reference Type BACKGROUND
PMID: 37052073 (View on PubMed)

Other Identifiers

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69HCL19_0114

Identifier Type: -

Identifier Source: org_study_id

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