Protective Ventilation Based on Alveolar Ventilation in Children

Anesthesia Clinical Trial

— PROVENTIPED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901599
• Other study ID #: 69HCL19_0114
• Status: Completed
• Start date: May 16, 2019
• Est. completion date: October 27, 2019

Study information

• Verified date: January 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 27, 2019
• Est. primary completion date: October 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Intraoperative Complications
• Peroperative Complication

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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