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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

2,032 Participants
are divided into 2 treatment groups
Group A: PEEP + PSVExperimental treatment 1 intervention
Group B: Induction in spontaneous breathingOther 1 intervention

Trial outcomes

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

Time frame
Day 0

Secondary outcomes

1

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

Risk difference and risk ratio at T4

Time frame
Day 0
2

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

Risk difference and risk ratio at T4

Time frame
Day 0
3

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

Risk difference and risk ratio at T4

Time frame
Day 0
4

Number of attempts to control the airways

Attempts at tracheal intubation or laryngeal mask insertion, as reported by the physician in charge. Risk difference and risk ratio at T4

Time frame
Day 0

Other outcomes

Sponsors and contacts

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