Clinical trial NCT04449042: The PAWS-COVID-19 (Pediatric AirWay complicationS COVID-19) Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
COVID19
Keywords: COVID19 pediatric
intubation
anesthesia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Children's Hospital Colorado
name: Istituto Giannina Gaslini
name: The Hospital for Sick Children
name: Perth Children's Hospital of Western Austrailia
name: Lurie Children's Hospital of Chicago
First posted: 2020-06-26
Enrollment: 14835
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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.

Primary outcomes:
measure: airway complications
timeFrame: throughout duration of anesthetic
Secondary outcomes:
measure: airway device
timeFrame: throughout duration of anesthetic
measure: PPE
timeFrame: throughout duration of anesthetic
measure: First pass success
timeFrame: during induction and intubation
measure: induction techniques
timeFrame: during induction of anesthesia
measure: failed intubation
timeFrame: during induction of anesthesia
measure: complication risk factors
timeFrame: during anesthetic management
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hopsital
state: Massachusetts
Study officials:
affiliation: Children's Hospital of Philadelphia
name: John E Fiadjoe, MD
role: STUDY_CHAIR
affiliation: Colorado Children's Hospital
name: Melissa Brooks Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References: