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NOT YET RECRUITING
NCT07767851
NA

Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Induction of anesthesia by inhalation is the most common method of induction (70% in France) for young children admitted for non-emergency surgery. It has the advantage of not requiring an intravenous line. Serious respiratory adverse events such as laryngospasm or bronchospasm remain common in young children during anesthesia induction (approximately 4%) and can reach up to 30% when mild respiratory adverse events (coughing, desaturation \< 95%, airway obstruction) are included. Traditionally, inhalation induction is performed under spontaneous ventilation using the anesthesia ventilator circuit. However, modern ventilators offer the option of applying positive end-expiratory pressure (PEEP) and pressure support ventilation (PSV). Several physiological studies suggest that the use of PEEP + PSV during anesthesia may help maintain airway patency, minute ventilation, and functional residual capacity (FRC). Our hypothesis is that administering PEEP + PSV at the time of induction may reduce the risk of respiratory complications. The primary objective is to demonstrate that induction of anesthesia using PEP + PSV, compared with induction of anesthesia under spontaneous ventilation, reduces the risk of adverse respiratory events in children requiring general anesthesia with planned inhalational induction.

Official title: Comparison of Two MOdalities of VEntilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children: a Multicentre Randomised Controlled Trial.

Key Details

Gender

All

Age Range

3 Months - 6 Years

Study Type

INTERVENTIONAL

Enrollment

2032

Start Date

2026-09-01

Completion Date

2029-09-01

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

PROCEDURE

Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)

Sevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation. In the experimental group, the level of PEEP will be set at 5 cmH2O and inspiratory support between 2 and 12 cmH2O and adjusted by the anaesthetist in charge to optimize respiratory mechanics and obtain a physiological tidal volume of 8ml/kg.

PROCEDURE

Induction in spontaneous breathing

Sevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation. In the control group, there is no PEEP

Locations (9)

Hôpital Femme Mère Enfant

Lyon, France

Hôpitaux Universitaires de Marseille Timone

Marseille, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

Hôpital Armand Trousseau

Paris, France

Hôpital Robert Debré

Paris, France

Centre Hospitalier Universitaire de Reims

Reims, France

Hôpital de Hautepierre

Strasbourg, France

CHU Toulouse - Hôpitaux des enfants

Toulouse, France