Study Stopped
The study was stopped due to a very low rate of children with COVID-19 pneumonia that required endotracheal intubation, resulting in no eligible subjects to enroll.
Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2020
CompletedFirst Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFebruary 15, 2023
February 1, 2023
2.5 years
August 18, 2020
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Transpulmonary pressure
Numerical data
Through study complication, usually 2 weeks
Study Arms (1)
Intubated pediatric patients with COVID-19 respiratory failure
EXPERIMENTALInterventions
Transpulmonary pressure measurements
Eligibility Criteria
You may qualify if:
- Patients 0-17 years of age, 10 kg or greater, with suspected or confirmed Covid-19 respiratory failure requiring endotracheal intubation and mechanical ventilation admitted to Mayo Clinic Hospital, St. Mary's Campus Pediatric Intensive Care Unit.
You may not qualify if:
- Patients \<10 kg
- Patients with pre-existing chronic mechanical ventilation (chronic respiratory failure)
- Patients with known esophageal disease (strictures, known esophageal anatomic abnormalities)
- Patients with severe coagulopathy (for which placement of esophageal balloon or other gastric tube via nose or mouth is contraindicated)
- Patients who are pregnant (as determined by standard pregnancy testing criteria for Pediatric ICU admission).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen J Gleich, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 19, 2020
Study Start
May 21, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share