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

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

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

Study Overview

• Status: Completed
• Conditions: Airway Management; COVID19
• Intervention / Treatment: Procedure: airway management during sedation or general anesthesia

• Study Type: Observational
• Enrollment (Actual): 14835

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all children (from birth to 18yrs) receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure. Each institution will collect de-identified data on all children under anesthetic care for a two week period. In addition, data collection for all children who are positive or presumed positive for COVID19 receiving anesthetic care will be collected outside of the two week period until study completion.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: The Hospital for Sick Children; Children's Hospital of Philadelphia; Children's Hospital Colorado; Istituto Giannina Gaslini; Lurie Children's Hospital of Chicago; Perth Children's Hospital of Western Austrailia
• Investigators: Study Chair: John E Fiadjoe, MD, Children's Hospital of Philadelphia; Principal Investigator: Melissa Brooks Peterson, MD, Colorado Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: anesthesia; intubation; COVID19 pediatric
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: IRB-P00035427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No