Airway ManagementNCT04449042
The PAWS-COVID-19 (Pediatric AirWay complicationS COVID-19) Registry
An observational study of Airway Management and COVID19, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Airway Management, COVID19
- What is being tested?
- airway management during sedation or general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 14,835 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 31 Oct 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hopsital
Boston, Massachusetts, 02115
About this study
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
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
- Being tested
- airway management during sedation or general anesthesia
- Keywords
- COVID19 pediatric, intubation, anesthesia
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway management during sedation or general anesthesiaProcedure or surgery
airway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| COVID19 positive | a recently performed test which is positive for coronavirus infection Receives: Procedure: airway management during sedation or general anesthesia | |
| COVID19 negative | a recently performed test which is negative for coronavirus infection Receives: 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 Receives: 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 Receives: Procedure: airway management during sedation or general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway complications
incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management
Measured: throughout duration of anesthetic
Secondary outcomes (6)
airway device
type of device inserted for airway control
Measured: throughout duration of anesthetic
PPE
the type of PPE used by anesthetists and assistants during airway management
Measured: throughout duration of anesthetic
First pass success
compare the first attempt success rate of tracheal intubation in patients with the disease to those without the disease
Measured: during induction and intubation
induction techniques
variability in practice for induction of anesthesia
Measured: during induction of anesthesia
failed intubation
determine the Incidence of failed intubation
Measured: during induction of anesthesia
complication risk factors
determine risk factors related to complications (PPE type, Location, Age, Baseline Saturation, Induction technique, clinician type)
Measured: during anesthetic management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Apr 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,835 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- 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, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Mary Lyn Stein, Boston Children's Hospital
- Investigators
- John E Fiadjoe, MD, Study chair, Children's Hospital of PhiladelphiaMelissa Brooks Peterson, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449042
- Sponsor's protocol ID
- IRB-P00035427
- Status last verified
- Oct 2021
- First submitted
- 22 Jun 2020
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04449042
- Acronym / sponsor ID
- IRB-P00035427
- Conditions
- Airway Management, COVID19
- Keywords
- COVID19 pediatric, intubation, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,835 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- 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, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID19 positive | – | Procedure: airway management during sedation or general anesthesiaa recently performed test which is positive for coronavirus infection |
| COVID19 negative | – | Procedure: airway management during sedation or general anesthesiaa recently performed test which is negative for coronavirus infection |
| COVID19 presumed positive | – | Procedure: airway management during sedation or general anesthesiapatients 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 |
| COVID19 presumed negative | – | Procedure: airway management during sedation or general anesthesiapatients 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| airway management during sedation or general anesthesiaairway management in children receiving sedation or general anesthesia for an elective, emergency, or urgent diagnostic or surgical procedure | Procedure or surgery | COVID19 negative, COVID19 positive, COVID19 presumed negative, COVID19 presumed positive |
Primary outcome
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
6 secondary outcomes
airway device
Time frame: throughout duration of anesthetic
PPE
Time frame: throughout duration of anesthetic
First pass success
Time frame: during induction and intubation
induction techniques
Time frame: during induction of anesthesia
failed intubation
Time frame: during induction of anesthesia
complication risk factors
Time frame: during anesthetic management
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Fiadjoe, MD study chair
Children's Hospital of Philadelphia
Melissa Brooks Peterson, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and COVID19, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway complications (time frame: throughout duration of anesthetic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.