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
  • Diagnostic Test: Transpulmonary pressure measurements
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

  1. 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:

Study Results

No Results Posted as of Feb 10, 2022