About this trial
Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged ≤ 16 years;
undergoing general anesthesia
airway management with tube or LMA; and
connected to mechanical ventilator . minimum duration of procedure: 15 minutes
Disqualifiers
patients undergoing surgical procedures involving extra-corporal circulation;
patients receiving ventilation with high frequency jet ventilation or high frequency oscillatory ventilation;
sedation without airway management in the form of a endotracheal tube or a supraglottic airway device; and
(rigid) bronchoscopic procedures with maintenance of spontaneous ventilation.
Trial population
Pediatric patients undergoing general anesthesia
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of postoperative pulmonary complications
incidence of postoperative pulmonary complications (PPCs) in the first five postoperative days. Definition of postoperative pulmonary complications: • Invasive mechanical ventilation after discharge from the operating room. * respiratory failure defined as: PaO2 \< 8 kPa or SpO2\< 90% despite oxygen therapy, with a need for non-invasive ventilation (NIV) * unplanned oxygen therapy, including humidified high flow nasal oxygen (oxygen administered due to PaO2\< 8 kPa or SpO2\< 90% in room air * need for bronchodilators postoperatively in the PACU or at the ward; * pneumonia; * ARDS; * pneumothorax.
Secondary outcomes
type of ventilation mode
what type of ventilation mode is chosen
Tidal volume (Vt)
average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.
postoperative end-expiratory pressure (PEEP)
level of PEEP
Peak inspiratory pressure or plateau pressure
Measured peak inspiratory or plateau pressure
Sponsors and contacts
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