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

NCT04597853 | Unknown

• 1 other identifier: 2020-01999
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; ARDS

Keywords

lung mechanics; heart-lung interaction

Outcome Measures

Primary Outcomes (3)

• Time dependent compliance change

  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

  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

  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)

Interventions

Assessment of lung mechanics and heart-lung interactions DIAGNOSTIC_TEST

Impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry and classic mechanical ventilation parameters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Institute of Intensive Care Medicine, University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philipp K Buehler, MD

  Institute of Intensive Care Medicine, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp K Buehler, MD

CONTACT

+41 43 25 31340; Philipp.Buehler@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 22, 2020
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

CH (1)