Mechanical Ventilation Complication, Pediatric ALL, Perioperative/Postoperative Complications, Pulmonary Complication
Conditions
Keywords
pediatric anesthesia, postoperative pulmonary complications, mechanical ventilation
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* aged ≤ 16 years; * undergoing general anesthesia * airway management with tube or LMA; and * connected to mechanical ventilator . minimum duration of procedure: 15 minutes
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative pulmonary complications | follow-up up to day 5 postoperative | 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
| Measure | Time frame | Description |
|---|---|---|
| Tidal volume (Vt) | 15 minutes after incision | average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used. |
| postoperative end-expiratory pressure (PEEP) | 15 minutes after incision | level of PEEP |
| Peak inspiratory pressure or plateau pressure | 15 minutes after incision | Measured peak inspiratory or plateau pressure |
| Level of pressure support above PEEP | 15 minutes after incision | Level of pressure support above PEEP, only in spontaneously breathing patients |
| Inspiratory fraction of oxygen (FiO2) | 15 minutes after incision | measured inspiratory O2 fraction |
| I:E ratio | 15 minutes after incision | I:E ratio or inspiratory time, measured in sec |
| Saturation (SpO2) | 15 mintues after incision | measured SpO2 |
| type of ventilation mode | 15 minutes after incision | what type of ventilation mode is chosen |
| Respiratory rate | 15 minutes after incision | set and actual respiratory rate |
| Compliance (Crs) | 15 minutes after incision | calculated compliance |
| Driving pressure | 15 mintues after incision | calculated driving pressure |
| Mechanical power | 15 minutes after incision | calculated mechanical power |
| Intraoperative complications | during surgery | intraoperative complications are defined as: oxygen desaturation (SpO2 \< 90%), hypercapnia (etCO2 \> 6.0), laryngospasm, bronchospasm, need for unplanned recruitment maneuvers, cardiac arrest. |
| Length of hospital stay | follow-up up to day 5 postoperative | total duration of stay in hospital, measured in days |
| Admittance to PICU or neonatal intensive care unit (NICU) | follow-up up to day 5 postoperative | planned and unplanned admission to PICU or NICU |
| end-tidal carbondioxide (etCO2) | 15 minutes after incision | measured etCO2 |
Countries
Australia, Italy, Netherlands, Switzerland
Contacts
Primary ContactJorinde Polderman, MD, PhD
Backup ContactDavid van Meenen, MD, PhD
Outcome results
None listed