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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorHospices Civils de Lyon

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

2,032 Participants
are divided into 2 treatment groups

Sponsors and collaborators