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Clinical Trials/NCT04597853
NCT04597853
Unknown
Not Applicable

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

University of Zurich1 site in 1 country25 target enrollmentMarch 1, 2021
ConditionsCovid19ARDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
University of Zurich
Enrollment
25
Locations
1
Primary Endpoint
PEEP and time dependent change in dead space
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
March 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

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

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

Study Sites (1)

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