Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04519411
Collaborator
(none)
10
1
1
31.3
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
Actual Study Start Date
:
May 21, 2020
Anticipated Primary Completion Date
:
Dec 31, 2022
Anticipated Study Completion Date
:
Dec 31, 2022
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intubated pediatric patients with COVID-19 respiratory failure
|
Diagnostic Test: Transpulmonary pressure measurements
Transpulmonary pressure measurements
|
Outcome Measures
Primary Outcome Measures
- Transpulmonary pressure [Through study complication, usually 2 weeks]
Numerical data
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
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).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Stephen J Gleich, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Stephen J. Gleich,
Principal Investigator,
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04519411
Other Study ID Numbers:
- 20-003743
First Posted:
Aug 19, 2020
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: