Protective Ventilation Based on Alveolar Ventilation in Children

NCT03901599 | Completed

• 1 other identifier: 69HCL19_0114
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Peroperative Complication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Children between 5-10Kg

Children with a body weight between 5-10Kg

Other: Alveolar ventilation monitoring estimated by the capnographic ventilation

Children between 10-20Kg

Children with a body weight between 10-20Kg

Other: Alveolar ventilation monitoring estimated by the capnographic ventilation

Children between 20-40Kg

Children with a body weight between 20-40Kg

Other: Alveolar ventilation monitoring estimated by the capnographic ventilation

Interventions

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.

Children between 10-20Kg; Children between 20-40Kg; Children between 5-10Kg

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under general anaesthesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 37052073 BACKGROUND

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: May 16, 2019
• Primary Completion: October 27, 2019
• Study Completion: October 27, 2019
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)