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Completed

NCT Number: NCT04449042

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

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Key information

Conditions

Airway Management COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Children's Hospital Colorado
  • Children's Hospital of Philadelphia
  • Istituto Giannina Gaslini
  • Perth Children's Hospital of Western Austrailia
  • The Hospital for Sick Children

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2020
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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