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

Covid19 Clinical Trial

— LungMechCoV-19  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597853
• Other study ID #: 2020-01999
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2021
• Source: University of Zurich
• Contact: Philipp K Buehler, MD
• Phone: +41 43 25 31340
• Email: Philipp.Buehler[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Covid19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Switzerland	Institute of Intensive Care Medicine, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)