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

NCT07767851 | Not Yet Recruiting

• 1 other identifier: 69HCL24_0926
• Study Type: interventional
• Target: 2,032
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Anaesthetic Induction; Respiratory Complications of Care; Pediatrics; Ventilation

Keywords

Anaesthetic induction; Ventilation; Respiratory complications; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough

  * 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

  Day 0

Secondary Outcomes (6)

• Number of respiratory adverse events among laryngospasm, bronchospasm and oxygen desaturation < 90%.

  Day 0

• Number of respiratory adverse events among airway obstruction, desaturation < 95% for more than 10s and severe cough

  Day 0

• Use of oropharyngeal cannula or need for manual ventilation for difficult ventilation.

  Day 0

• Number of attempts to control the airways

  Day 0

• Number of gastric distension requiring evacuation

  Day 0

Study Arms (2)

PEEP + PSV

EXPERIMENTAL

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

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

Induction in spontaneous breathing

OTHER

Procedure: Induction in spontaneous breathing

Interventions

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

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.

PEEP + PSV

Induction in spontaneous breathing PROCEDURE

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

Induction in spontaneous breathing

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Failure of venous access after 30 min or more than 5 attempts
• Parents' consent withdrawal

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (9)

Hôpital Femme Mère Enfant

Lyon, 69677, France

Location

Hôpitaux Universitaires de Marseille Timone

Marseille, 13385, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Centre Hospitalier Universitaire de Reims

Reims, 51092, France

Location

Hôpital de Hautepierre

Strasbourg, 67200, France

Location

CHU Toulouse - Hôpitaux des enfants

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Neoadjuvant Therapy; Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Respiration, Artificial; Airway Management; Respiratory Therapy

Central Study Contacts

Florent BAUDIN, Pr

CONTACT

+00334 72 12 97 35; florent.baudin@chu-lyon.fr

Clarisse Saunier

CONTACT

+0033427856264; clarisse.saunier@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

FR (9)