Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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