COVID-19PHYSIO-COVIDNCT04347928
Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19
An observational study of COVID-19 and ARDS, run by University Hospital, Lille at 1 site in France.
Trial summary
In the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to COVID-19. From these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2020to 6 Nov 2020
- 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: patient hospitalized in ICU mechanically ventilated for less than 72 hours
Who may be able to join
- hospitalized in intensive care for a SARS-CoV2 infection
- requiring invasive ventilation,
- intubated for less than 72 hours with PaO2/FiO2 ratio < 200 mmHg
Who cannot join
- Patient mechanically ventilated for 72 hours or more
- Patient with documented respiratory co-infection
- Patient with a contraindication to pulmonary artery catheter insertion: High risk of bleeding, pre-existing high degree of atrioventricular heart block , Pace Maker
- Patient with spontaneous ventilation
- Patient with severe ARDS with static compliance of the respiratory system < 20 mL/cmH2O
- Patient with severe ARDS with indication of prone positioning at inclusion.
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- Patient with a cardiac condition that renders the measurement of pulmonary artery occlusion pressure uninterpretable as a surrogate for left ventricle end diastolic pressure (severe mitral insufficiency, severe mitral stricture, severe aortic insufficiency).
- Patient with intracardiac shunt
- Patient with ECMO
- Minors and pregnant women.
- Person not affiliated to or not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
In the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to COVID-19. From these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. It therefore seems essential to rigorously study these modifications, as they have been studied in the past for ARDS.
The aim of this non-interventional study is to describe precisely the respiratory and hemodynamic changes induced by COVID-19 in mechanically ventilated patients
.
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
intrapulmonary shunt ratio
Measured: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Secondary outcomes (3)
Evolution of respiratory variables
Evaluation of PaO2 variation between in a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)
Measured: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Evolution of respiratory variables
Evaluation of PaCO2 variation between in a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)
Measured: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Evolution of hemodynamic stability variables
Evaluation of cardiac output variation between a high level of PEEP (15cmH2O) and a low level of PEEP (5cmH2O)
Measured: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start20 Apr 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault Duburcq, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347928
- Sponsor's protocol ID
- 2020_32
- Other IDs
- 2020-A00957-32
- Acronym
- PHYSIO-COVID
- Status last verified
- May 2020
- First submitted
- 8 Apr 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19
- ClinicalTrials.gov ID
- NCT04347928
- Acronym / sponsor ID
- PHYSIO-COVID / 2020_32
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 15 Apr 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.
In the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to COVID-19. From these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. It therefore seems essential to rigorously study these modifications, as they have been studied in the past for ARDS.
The aim of this non-interventional study is to describe precisely the respiratory and hemodynamic changes induced by COVID-19 in mechanically ventilated patients
.
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
- patient hospitalized in ICU mechanically ventilated for less than 72 hours
Key inclusion criteria (3 listed)
- hospitalized in intensive care for a SARS-CoV2 infection
- requiring invasive ventilation,
- intubated for less than 72 hours with PaO2/FiO2 ratio < 200 mmHg
Key exclusion criteria (11 listed)
- Patient mechanically ventilated for 72 hours or more
- Patient with documented respiratory co-infection
- Patient with a contraindication to pulmonary artery catheter insertion: High risk of bleeding, pre-existing high degree of atrioventricular heart block , Pace Maker
- Patient with spontaneous ventilation
- Patient with severe ARDS with static compliance of the respiratory system < 20 mL/cmH2O
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intrapulmonary shunt ratio
Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
3 secondary outcomes
Evolution of respiratory variables
Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Evolution of respiratory variables
Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Evolution of hemodynamic stability variables
Time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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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.
Thibault Duburcq, MD principal investigator
University Hospital, Lille
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 COVID-19 and ARDS, run by University Hospital, Lille at 1 site in France.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 17 Nov 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intrapulmonary shunt ratio (time frame: during ICU stay, in the first 72 hours of mechanical ventilation initiation). 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 17 Nov 2020.