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

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04449042
• Collaborator: Children's Hospital of Philadelphia (Other), Children's Hospital Colorado (Other), Istituto Giannina Gaslini (Other), The Hospital for Sick Children (Other), Perth Children's Hospital of Western Austrailia (Other), Lurie Children's Hospital of Chicago (Other)
• Enrollment: 14,835
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 2119.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Airway Management; COVID19	Procedure: airway management during sedation or general anesthesia

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 14835 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Apr 1, 2020
• Actual Primary Completion Date: Oct 31, 2020
• Actual Study Completion Date: Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
COVID19 positive a recently performed test which is positive for coronavirus infection	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
COVID19 negative a recently performed test which is negative for coronavirus infection	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
COVID19 presumed positive 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; airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure
COVID19 presumed negative 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; airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure

Outcome Measures

Primary Outcome Measures

1. 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

1. airway device [throughout duration of anesthetic]

   type of device inserted for airway control

2. PPE [throughout duration of anesthetic]

   the type of PPE used by anesthetists and assistants during airway management

3. 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

4. induction techniques [during induction of anesthesia]

   variability in practice for induction of anesthesia

5. failed intubation [during induction of anesthesia]

   determine the Incidence of failed intubation

6. complication risk factors [during anesthetic management]

   determine risk factors related to complications (PPE type, Location, Age, Baseline Saturation, Induction technique, clinician type)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hopsital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Boston Children's Hospital
• Children's Hospital of Philadelphia
• Children's Hospital Colorado
• Istituto Giannina Gaslini
• The Hospital for Sick Children
• Perth Children's Hospital of Western Austrailia
• Lurie Children's Hospital of Chicago

Investigators

• Study Chair: John E Fiadjoe, MD, Children's Hospital of Philadelphia
• Principal Investigator: Melissa Brooks Peterson, MD, Colorado Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mary Lyn Stein, Assistant in Perioperative Anesthesia, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT04449042
• Other Study ID Numbers: IRB-P00035427
• First Posted: Jun 26, 2020
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mary Lyn Stein, Assistant in Perioperative Anesthesia, Boston Children's Hospital: COVID19 pediatric; intubation; anesthesia
• Additional relevant MeSH terms: COVID-19; Anesthetics

Study Results

No Results Posted as of Oct 22, 2021