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

NCT ID: NCT04449042

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14835 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-10-31

Brief Summary

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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

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Conditions

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Airway Management COVID19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID19 positive

a recently performed test which is positive for coronavirus infection

airway management during sedation or general anesthesia

Intervention Type PROCEDURE

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

airway management during sedation or general anesthesia

Intervention Type PROCEDURE

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

airway management during sedation or general anesthesia

Intervention Type PROCEDURE

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

airway management during sedation or general anesthesia

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Children's Hospital Colorado

OTHER

Sponsor Role collaborator

Istituto Giannina Gaslini

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Perth Children's Hospital of Western Austrailia

UNKNOWN

Sponsor Role collaborator

Lurie Children's Hospital of Chicago

UNKNOWN

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mary Lyn Stein

Assistant in Perioperative Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John E Fiadjoe, MD

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

Melissa Brooks Peterson, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Children's Hospital

Locations

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Boston Children's Hopsital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00035427

Identifier Type: -

Identifier Source: org_study_id