Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Study Overview
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Brief Summary
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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
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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 ICU 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 ICU admittance.

Official Title
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Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study

Conditions
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Mechanical Ventilation Complication, Pediatric ALL, Pulmonary Complication, Perioperative/Postoperative Complications

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates<br>neonates up to 44 weeks postmenstrual age or up to 60 weeks post menstrual age if born premature (GA <37 weeks) undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | |
| Infants<br>Infants of 1 month to 1 year old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | |
| Toddlers<br>Toddlers of 1 to 3 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | |
| Preschool<br>Children of preschool age 3 to 6 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | |
| School-aged and adolescents<br>School aged children and adolescents of 6 to17 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | follow-up up to day 5 postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of ventilation mode | what type of ventilation mode is chosen | 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. | 15 minutes after incision | 
| PEEP | level of PEEP | 15 minutes after incision | 
| Peak inspiratory pressure or plateau pressure | Measured peak inspiratory or plateau pressure | 15 minutes after incision | 
| Level of pressure support above PEEP | Level of pressure support above PEEP, only in spontaneously breathing patients | 15 minutes after incision | 
| FiO2 | measured inspiratory O2 fraction | 15 mintues after incision | 
| I:E ratio | I:E ratio or inspiratory time, measured in sec | 15 minutes after incision | 
| SpO2 | measured SpO2 | 15 mintues after incision | 
| etCO2 | measured etCO2 | 15 minutes after incision | 
| Respiratory rate | set and actual respiratory rate | 15 minutes after incision | 
| Compliance (Crs) | calculated compliance | 15 minutes after incision | 
| Driving pressure | calculated driving pressure | 15 mintues after incision | 
| Mechanical power | calculated mechanical power | 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. | during surgery | 
| Length of hospital stay | total duration of stay in hospital, measured in days | follow-up up to day 5 postoperative | 
| Admittance to PICU or NICU | planned and unplanned admission to PICU or NICU | follow-up up to day 5 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric anesthesia, postoperative pulmonary complications, mechanical ventilation