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Starting soon Not applicable

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

NCT07767851 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-11-01
Last updated
2026-10-26

Condition(s) studied

Anaesthetic InductionRespiratory Complications of CarePediatricsVentilation

Investigational drug(s) / intervention(s)

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

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
3 Months
Max age
6 Years
Healthy volunteers
No
Inclusion Criteria: * Child between 3 months and 6 years old * Without significant comorbidity (ASA 1 or 2) * Admitted for elective or emergency/urgent surgery under general anesthesia * With induction of anaesthesia by inhalation by sevoflurane on the machine circuit * With airway control by intubation tube or supraglottic device * Consent of at least one parent or legal guardian Exclusion Criteria: * Children with severe upper respiratory tract infection (severe moist cough, fever and lethargy, oxygen requirement) in the last 7 days requiring intravenous induction or postpone of the surgery * Thoracic surgery with selective control of intubation * Criteria for difficult intubation or known history of difficult intubation * Children with a contraindication to sevoflurane (ex: risk of malignant hyperthermia) * Children asking for intravenous induction or requiring rapid sequence induction * Children with significant cardiac disease (pulmonary hypertension, cyanotic heart disease,…) * Children not affiliated or beneficiary of a health insurance system * Children participating in other interventional research with an exclusion period still in progress at inclusion Exclusion Criteria : * Failure of venous access after 30 min or more than 5 attempts * Parents' consent withdrawal

Primary outcome measure(s)

  • Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough — Day 0
    * Laryngospasm: complete or partial obstruction of the airway associated with rigidity of the abdominal and thoracic muscles measured by the physician in charge * Bronchospasm: increase in work of breathing, particularly in exhalation (signs of respiratory distress) with wheezing measured by the physician in charge * Oxygen desaturation: \<95% more than 10 sec or \< 90% measured by the physician in charge * Airway obstruction: airway obstruction with inspiratory noise and increased work of breathing or requiring manual ventilation measured by the physician in charge * Severe cough: coughing fit lasting more than 10 sec or requiring drug intervention (intravenous anaesthetic agents, lidocaine, neuromuscular blockade agents) measured by the physician in charge

Trial sites (9)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07767851 on ClinicalTrials.gov ↗ ← All trials in France