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

NCT04449042 | Completed

• 1 other identifier: IRB-P00035427
• Study Type: observational
• Target: 14,835
• Locations: 1 country
• Sites: 1

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

Conditions

Airway Management; COVID19

Keywords

COVID19 pediatric; intubation; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• airway device

  throughout duration of anesthetic

• PPE

  throughout duration of anesthetic

• First pass success

  during induction and intubation

• induction techniques

  during induction of anesthesia

• failed intubation

  during induction of anesthesia

Study Arms (4)

COVID19 positive

a recently performed test which is positive for coronavirus infection

Procedure: airway management during sedation or general anesthesia

COVID19 negative

a recently performed test which is negative for coronavirus infection

Procedure: airway management during sedation or general anesthesia

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

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

Interventions

airway management during sedation or general anesthesia PROCEDURE

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

COVID19 negative; COVID19 positive; COVID19 presumed negative; COVID19 presumed positive

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• John E Fiadjoe, MD

  Children's Hospital of Philadelphia

  STUDY CHAIR

• Melissa Brooks Peterson, MD

  Colorado Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Perioperative Anesthesia

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 26, 2020
• Study Start: April 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

US (1)