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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | 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 | Infants of 1 month to 1 year old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | ||
| Toddlers | Toddlers of 1 to 3 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | ||
| Preschool | Children of preschool age 3 to 6 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. | ||
| School-aged and adolescents | School aged children and adolescents of 6 to17 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered. |
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| 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.
| follow-up up to day 5 postoperative |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients undergoing general anesthesia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorinde Polderman, MD, PhD | Contact | +31205669111 | j.a.polderman@amsterdamumc.nl | |
| David van Meenen, MD, PhD | Contact | +31205669111 | d.m.vanmeenen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marcus Schultz, Prof | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perth Children's Hospital | Not yet recruiting | Perth | Australia |
Authors of the publication will be team members of the steering committee who contributed to the design, conduct or analysis of the study and who approved of the final version of the manuscript, plus the BIG APPLE investigators. All participating investigators will be collaborator of this group and will be included on all publications from the BIG APPLE database. Local PIs agree not to individually publish or present the results they obtain from the participation in this multicenter study before the publication of the main results of the study. According to FAIR data principles, the pooled dataset will be available for all members of the BIG APPLE collaboration on request for secondary analyses after judgement and approval of scientific quality and validity by the Steering Committee.
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| 15 minutes after incision |
| postoperative end-expiratory pressure (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 |
| Inspiratory fraction of oxygen (FiO2) | measured inspiratory O2 fraction | 15 minutes after incision |
| I:E ratio | I:E ratio or inspiratory time, measured in sec | 15 minutes after incision |
| Saturation (SpO2) | measured SpO2 | 15 mintues after incision |
| end-tidal carbondioxide (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 neonatal intensive care unit (NICU) | planned and unplanned admission to PICU or NICU | follow-up up to day 5 postoperative |
| IRCCS Istituto Giannina Gaslini | Not yet recruiting | Genoa | Italy |
|
| Amsterdam University Medical Centers | Recruiting | Amsterdam | Please Select | 1105AZ | Netherlands |
|
| Universitatsspital Bern | Not yet recruiting | Bern | Switzerland |
|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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