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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04597853
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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.


Condition or disease Intervention/treatment
Covid19 ARDS Diagnostic Test: Assessment of lung mechanics and heart-lung interactions

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Lung Mechanics in SARS-CoV-2/ COVID-19 Acute Respiratory Distress Syndrome: A Holistic, Longitudinal Analysis of the Lung-heart-ventilator Interaction
Estimated Study Start Date : October 20, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021



Intervention Details:
  • Diagnostic Test: Assessment of lung mechanics and heart-lung interactions
    Impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry and classic mechanical ventilation parameters


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597853


Contacts
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Contact: Philipp K Buehler, MD +41 43 25 31340 Philipp.Buehler@usz.ch

Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04597853    
Other Study ID Numbers: 2020-01999
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
lung mechanics
heart-lung interaction
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury