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Completed

NCT Number: NCT03901599

Protective Ventilation Based on Alveolar Ventilation in Children

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.

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Key information

Conditions

Anesthesia Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Peroperative Complication

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alveolar ventilation monitoring estimated by the capnographic ventilation

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.

Primary outcomes

  1. Determination of target alveolar minute volume to maintain normocapnia in children without mechanical ventilation.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PROVENTIPED

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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