Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 16
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 5 trial groups
Group A: Neonates
Group B: Infants
Group C: Toddlers
Group D: Preschool
Group E: School-aged and adolescents

Trial outcomes

Primary outcomes

1

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.

Time frame
follow-up up to day 5 postoperative

Secondary outcomes

1

type of ventilation mode

what type of ventilation mode is chosen

Time frame
15 minutes after incision
2

Tidal volume (Vt)

average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.

Time frame
15 minutes after incision
3

postoperative end-expiratory pressure (PEEP)

level of PEEP

Time frame
15 minutes after incision
4

Peak inspiratory pressure or plateau pressure

Measured peak inspiratory or plateau pressure

Time frame
15 minutes after incision

Other outcomes

Sponsors and contacts

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