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

COVID19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449042
• Other study ID #: IRB-P00035427
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14835
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management
• COVID-19
• COVID19

Intervention

Procedure:
• airway management during sedation or general anesthesia
airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure

Locations

Country	Name	City	State
United States	Boston Children's Hopsital	Boston	Massachusetts

Sponsors (7)

Lead Sponsor	Collaborator
Boston Children's Hospital	Children's Hospital Colorado, Children's Hospital of Philadelphia, Istituto Giannina Gaslini, Lurie Children's Hospital of Chicago, Perth Children's Hospital of Western Austrailia, The Hospital for Sick Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	airway device	type of device inserted for airway control	throughout duration of anesthetic
Secondary	PPE	the type of PPE used by anesthetists and assistants during airway management	throughout duration of anesthetic
Secondary	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
Secondary	induction techniques	variability in practice for induction of anesthesia	during induction of anesthesia
Secondary	failed intubation	determine the Incidence of failed intubation	during induction of anesthesia
Secondary	complication risk factors	determine risk factors related to complications (PPE type, Location, Age, Baseline Saturation, Induction technique, clinician type)	during anesthetic management