The PAWS-COVID-19 (Pediatric AirWay complicationS COVID-19) Registry

Study Overview
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Brief Summary
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The COVID-19 pandemic has disrupted anesthesia care all over the world. There remains very little data on current practice patterns and patient outcomes, particularly in anesthetized children. This is a prospective observational, multi-center study to investigate airway management related outcomes in children undergoing anesthesia during this pandemic. The investigators will compare the incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management. PAWS COVID-19 Registry https://is.gd/PEDICOVID19 Registration link https://is.gd/researchrequest

Official Title
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Pediatric Airway Management Complications During the COVID-19 Pandemic. An International, Multicenter, Observational Registry: The PAWS-COVID-19 (Pediatric AirWay complicationS COVID-19) Registry

Conditions
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Airway Management, COVID19

Intervention / Treatment
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* Procedure: airway management during sedation or general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing an inpatient or outpatient procedure under general anesthesia with or without regional analgesia Undergoing a diagnostic procedure under sedation or general anesthesia Undergoing an urgent or emergent procedure performed during and outside of the regular operating room schedule hours. Exclusion Criteria: Age > 18 years. Children admitted to the operating room already intubated Children who require tracheal intubation for life-threatening conditions in the emergency department, intensive care, or hospital ward.

Ages Eligible for Study
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Maximum Age: 18 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 |
| --- | --- |
| COVID19 positive<br>a recently performed test which is positive for coronavirus infection | Procedure: airway management during sedation or general anesthesia<br>* airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure<br>|
| COVID19 negative<br>a recently performed test which is negative for coronavirus infection | Procedure: airway management during sedation or general anesthesia<br>* airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure<br>|
| COVID19 presumed positive<br>patients who do not have testing or who have negative testing but whose symptoms, history, physical exam, laboratory and imaging findings are consistent with infection with COVID19 and are treated as positive | Procedure: airway management during sedation or general anesthesia<br>* airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure<br>|
| COVID19 presumed negative<br>patients who do not have testing, but based on symptoms, history, physical exam, laboratory and imaging findings are deemed to be low risk for COVID19 infection and are treated as negative | Procedure: airway management during sedation or general anesthesia<br>* airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway complications | incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management | throughout duration of anesthetic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway device | type of device inserted for airway control | throughout duration of anesthetic | 
| PPE | the type of PPE used by anesthetists and assistants during airway management | throughout duration of anesthetic | 
| First pass success | compare the first attempt success rate of tracheal intubation in patients with the disease to those without the disease | during induction and intubation | 
| induction techniques | variability in practice for induction of anesthesia | during induction of anesthesia | 
| failed intubation | determine the Incidence of failed intubation | during induction of anesthesia | 
| complication risk factors | determine risk factors related to complications (PPE type, Location, Age, Baseline Saturation, Induction technique, clinician type) | during anesthetic management | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19 pediatric, intubation, anesthesia