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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449042
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : June 26, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Mary Lyn Stein, Boston Children’s Hospital

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
Airway Management COVID19 Procedure: airway management during sedation or general anesthesia

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
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 : April 1, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

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




Primary Outcome Measures :
  1. airway complications [ Time Frame: 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 [ Time Frame: throughout duration of anesthetic ]
    type of device inserted for airway control

  2. PPE [ Time Frame: throughout duration of anesthetic ]
    the type of PPE used by anesthetists and assistants during airway management

  3. First pass success [ Time Frame: 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 [ Time Frame: during induction of anesthesia ]
    variability in practice for induction of anesthesia

  5. failed intubation [ Time Frame: during induction of anesthesia ]
    determine the Incidence of failed intubation

  6. complication risk factors [ Time Frame: during anesthetic management ]
    determine risk factors related to complications (PPE type, Location, Age, Baseline Saturation, Induction technique, clinician type)



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449042


Contacts
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Contact: Mary Lyn Stein, MD 617-355-7737 Mary.Stein@childrens.harvard.edu
Contact: Pete Kovatsis, MD 617-355-7737 Pete.Kovatsis@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hopsital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mary Lyn Stein, MD    617-355-7737    Mary.Stein@childrens.harvard.edu   
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
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Study Chair: John E Fiadjoe, MD Children's Hospital of Philadelphia
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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: June 26, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Lyn Stein, Boston Children’s Hospital:
COVID19 pediatric
intubation
anesthesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs