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.
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. Objective The aims of this study are to: * determine the incidence of PPCs in pediatric patients; * describe the practice of ventilatory support in children undergoing general anesthesia; * describe geo-economic differences/variations in ventilatory support and development of PPCs in children undergoing general anesthesia; * identify potentially modifiable factors that have independent associations with development of PPCs, hospital length of stay and pediatric intensive care unit (PICU) admittance; and * develop a risk score for the development of PPCs comparable to the ARISCAT score. Study design Multicenter international observational cohort study. Study population Patients ≤16 years of age undergoing invasive ventilation for general anesthesia in the operating room. Main study endpoints The primary endpoint is the incidence of PPCs. Secondary outcomes are the ventilator settings, ventilation parameters, length of hospital stay and PICU admittance.
Study Type
OBSERVATIONAL
Enrollment
10,000
Perth Children's Hospital
Perth, Australia
NOT_YET_RECRUITINGIRCCS Istituto Giannina Gaslini
Genoa, Italy
NOT_YET_RECRUITINGAmsterdam University Medical Centers
Amsterdam, Please Select, Netherlands
RECRUITINGUniversitatsspital Bern
Bern, Switzerland
NOT_YET_RECRUITINGIncidence 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
type of ventilation mode
what type of ventilation mode is chosen
Time frame: 15 minutes after incision
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
postoperative end-expiratory pressure (PEEP)
level of PEEP
Time frame: 15 minutes after incision
Peak inspiratory pressure or plateau pressure
Measured peak inspiratory or plateau pressure
Time frame: 15 minutes after incision
Level of pressure support above PEEP
Level of pressure support above PEEP, only in spontaneously breathing patients
Time frame: 15 minutes after incision
Inspiratory fraction of oxygen (FiO2)
measured inspiratory O2 fraction
Time frame: 15 minutes after incision
I:E ratio
I:E ratio or inspiratory time, measured in sec
Time frame: 15 minutes after incision
Saturation (SpO2)
measured SpO2
Time frame: 15 mintues after incision
end-tidal carbondioxide (etCO2)
measured etCO2
Time frame: 15 minutes after incision
Respiratory rate
set and actual respiratory rate
Time frame: 15 minutes after incision
Compliance (Crs)
calculated compliance
Time frame: 15 minutes after incision
Driving pressure
calculated driving pressure
Time frame: 15 mintues after incision
Mechanical power
calculated mechanical power
Time frame: 15 minutes after incision
Intraoperative complications
intraoperative complications are defined as: oxygen desaturation (SpO2 \< 90%), hypercapnia (etCO2 \> 6.0), laryngospasm, bronchospasm, need for unplanned recruitment maneuvers, cardiac arrest.
Time frame: during surgery
Length of hospital stay
total duration of stay in hospital, measured in days
Time frame: follow-up up to day 5 postoperative
Admittance to PICU or neonatal intensive care unit (NICU)
planned and unplanned admission to PICU or NICU
Time frame: follow-up up to day 5 postoperative
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