Assessment of Lung Mechanics in COVID-19 Acute Respiratory Distress Syndrome (LungMechCoV-19)

May 5, 2021 updated by: University of Zurich

Assessment of Lung Mechanics in SARS-CoV-2/ COVID-19 Acute Respiratory Distress Syndrome: A Holistic, Longitudinal Analysis of the Lung-heart-ventilator Interaction

This study is meant to assess the lung mechanics in SARS-CoV-2 induced acute respiratory failure. A precise characterisation of lung mechanics and heart-lung-interactions might allow a better understanding of SARS-CoV-2 induced acute respiratory failure and thus lead to better mechanical ventilation strategies.

This monocentric, observational study of critically ill COVID-19 patients in the ICU, will employ impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry as well as classic mechanical ventilation parameters to characterise the mechanical characteristics of the lung as well as the heart-lung interactions in SARS-CoV-2 induced acute respiratory failure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • Institute of Intensive Care Medicine, University Hospital Zurich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The project population targeted with this research, consists of a critically ill COVID-19 diagnosed population being admitted to the Institute of Intensive Care of the University Hospital Zurich and treated with mechanical ventilation.

Description

Inclusion Criteria:

  • SARS-CoV-2 infection
  • Moderate to Severe ARDS after Berlin Classification at PEEP 5
  • Admission to the Institute of Intensive Care of the University Hospital Zurich
  • Invasive Mechanical Ventilation
  • Signed Study Informed Consent or emergency procedure according to article 30 HFG

Exclusion Criteria:

  • Pregnant or breast feeding patients
  • Age <18 years
  • Presumed rejection of the study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time dependent compliance change
Time Frame: Mixed Model Assessment of compliance over time until extubation (measurements every 2 days up to 90 days)
Compliance change over the length of mechanical ventilation
Mixed Model Assessment of compliance over time until extubation (measurements every 2 days up to 90 days)
PEEP and time dependent change in dead space
Time Frame: Mixed Model Assessment of Dead Space over time until extubation (measurements every 2 days up to 90 days)
Change in Dead Space over the length of mechanical ventilation
Mixed Model Assessment of Dead Space over time until extubation (measurements every 2 days up to 90 days)
PEEP and time dependent change in shunt fraction
Time Frame: Mixed Model Assessment of shunt fraction over time until extubation (measurements every 2 days up to 90 days)
Change in shunt fraction over the length of mechanical ventilation
Mixed Model Assessment of shunt fraction over time until extubation (measurements every 2 days up to 90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Philipp K Buehler, MD, Institute of Intensive Care Medicine, University Hospital Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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