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Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure

Primary Purpose

COVID 19

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transpulmonary pressure measurements
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID 19

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intubated pediatric patients with COVID-19 respiratory failure

    Arm Description

    Outcomes

    Primary Outcome Measures

    Transpulmonary pressure
    Numerical data

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2020
    Last Updated
    February 13, 2023
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04519411
    Brief Title
    Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
    Official Title
    Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why 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.
    Study Start Date
    May 21, 2020 (Actual)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID 19

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intubated pediatric patients with COVID-19 respiratory failure
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Transpulmonary pressure measurements
    Intervention Description
    Transpulmonary pressure measurements
    Primary Outcome Measure Information:
    Title
    Transpulmonary pressure
    Description
    Numerical data
    Time Frame
    Through study complication, usually 2 weeks

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen J Gleich, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure

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