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

NCT ID: NCT04519411

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.

Detailed Description

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Conditions

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COVID 19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intubated pediatric patients with COVID-19 respiratory failure

Group Type EXPERIMENTAL

Transpulmonary pressure measurements

Intervention Type DIAGNOSTIC_TEST

Transpulmonary pressure measurements

Interventions

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Transpulmonary pressure measurements

Transpulmonary pressure measurements

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Stephen J. Gleich

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen J Gleich, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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20-003743

Identifier Type: -

Identifier Source: org_study_id

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