Covid19LungMechCoV-19NCT04597853
Assessment of Lung Mechanics in COVID-19 Acute Respiratory Distress Syndrome
An observational study of Covid19 and ARDS, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Assessment of lung mechanics and heart-lung interactions
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant or breast feeding patients
- Age <18 years
- Presumed rejection of the study intervention
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Institute of Intensive Care Medicine, University Hospital Zurich
Zurich, 8091
Philipp K Buehler, MD, philipp.buehler@usz.ch
About this study
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
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.
- Being tested
- Assessment of lung mechanics and heart-lung interactions
- Keywords
- lung mechanics, heart-lung interaction
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of lung mechanics and heart-lung interactionsDiagnostic test
Impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry and classic mechanical ventilation parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
Time dependent compliance change
Compliance change over the length of mechanical ventilation
Measured: 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
Measured: 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
Measured: Mixed Model Assessment of shunt fraction over time until extubation (measurements every 2 days up to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp K Buehler, MD, Principal investigator, Institute of Intensive Care Medicine, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597853
- Sponsor's protocol ID
- 2020-01999
- Acronym
- LungMechCoV-19
- Status last verified
- May 2021
- First submitted
- 19 Oct 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04597853
- Acronym / sponsor ID
- LungMechCoV-19 / 2020-01999
- Keywords
- lung mechanics, heart-lung interaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant or breast feeding patients
- Age <18 years
- Presumed rejection of the study intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of lung mechanics and heart-lung interactionsImpedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry and classic mechanical ventilation parameters | Diagnostic test | – |
Primary outcome
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 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp K Buehler, MD principal investigator
Institute of Intensive Care Medicine, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and ARDS, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp K Buehler, MD (+41 43 25 31340, Philipp.Buehler@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time dependent compliance change (time frame: Mixed Model Assessment of compliance over time until extubation (measurements every 2 days up to 90 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.