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NCT Number: NCT07767851

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

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.

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Key information

Conditions

Anaesthetic Induction Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatrics Respiration Disorders Respiratory Aspiration Respiratory Complications of Care Respiratory Tract Diseases Ventilation

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme Mère Enfant, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: 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

Secondary outcomes

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

    Time frame: Day 0

    Risk difference and risk ratio at T4

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

    Time frame: Day 0

    Risk difference and risk ratio at T4

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

    Time frame: Day 0

    Risk difference and risk ratio at T4

  4. Number of attempts to control the airways

    Time frame: Day 0

    Attempts at tracheal intubation or laryngeal mask insertion, as reported by the physician in charge.

    Risk difference and risk ratio at T4

  5. Number of gastric distension requiring evacuation

    Time frame: Day 0

    Reported by the physician in charge. Risk difference and risk ratio at T4

  6. Pressure support (cmH2O) and tidal volumes (ml/Kg)

    Time frame: Day 0

    Pressure support (cmH2O) set on the ventilator by the physician in charge (continuous variable) Tidal volumes measured on the ventilator by the physician in charge (continuous variable)

    Relation between the pressure support and the tidal volume at each time T1 and T2 separately

Study contacts

Contact information is provided by the study sponsor or research team.

Clarisse Saunier

CONTACT

[email protected]

+0033427856264

Florent BAUDIN, Pr

CONTACT

[email protected]

+00334 72 12 97 35

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PEDIAMOVE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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