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

Completed

• Conditions: COVID19; Airway Management
• Interventions: Procedure: airway management during sedation or general anesthesia

• Registration Number: NCT04449042
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-26
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14835

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID19 negative	airway management during sedation or general anesthesia	a recently performed test which is negative for coronavirus infection
COVID19 positive	airway management during sedation or general anesthesia	a recently performed test which is positive for coronavirus infection
COVID19 presumed positive	airway management during sedation or general anesthesia	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
COVID19 presumed negative	airway management during sedation or general anesthesia	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

Primary Outcome Measures

Name	Time	Method
airway complications	throughout duration of anesthetic	incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Boston Children's Hopsital; 🇺🇸 Boston, Massachusetts, United States