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Protective Ventilation Based on Alveolar Ventilation in Children

Feasibility of Protective Ventilation Based on the Alveolar Ventilation in Paediatric Anaesthesiology and Intensive Care.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03901599
Acronym
PROVENTIPED
Enrollment
60
Registered
2019-04-03
Start date
2019-05-16
Completion date
2019-10-27
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Peroperative Complication

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.

Interventions

OTHERAlveolar 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026