Mechanical VentilationTRANSPULMONARYNCT04381286
Transpulmonary Driving Pressure in ARDS COVID19 Patients
An observational study of Mechanical Ventilation and SARS-CoV-2, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed an acute respiratory distress syndrome (ARDS) according to BERLIN criteria. Gattinoni et al. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation, SARS-CoV-2, COVID-19
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 31 Dec 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with SARS-CoV-2 and mechanical ventilation requirement
Who may be able to join
- Major patients (18-90 years old)
- Hospitalized following SARS-CoV-2
- Mechanical ventilatory support
Who cannot join
- Minor patients
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Ramin SEVERIN, MD, 467338256 ext. 33, o-choquet@chu-montpellier.fr
About this study
Official title: Transpulmonary Driving Pressure in ARDS COVID19 Patients / TRANSPULMONARY-COVID19
A majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed an acute respiratory distress syndrome (ARDS) according to BERLIN criteria. Gattinoni et al. recently described that the ARDS related to SARS-CoV-2 was not a "Typical" ARDS. Patients affected by this infection present indeed a major hypoxemia, which was surprisingly associated in early phase with a high compliance of respiratory system, more than 50 ml/cm H2O in most cases. The cornerstone of current treatment in case of ARDS is the use of "lung protective" ventilation, including limited tidal volumes (VT), low end-inspiratory plateau pressures while maintaining sufficiently-high positive end-expiratory pressures (PEEP). However, high levels of PEEP in patients may have detrimental effects on hemodynamic status and fluid retention, particularly when the respiratory system compliance is normal. High PEEP may also lead to overdistension and an increase of alveolar dead space. The airway pressures commonly monitored does not reliably reflect the impact of pressures on the lung parenchyma. Elastance of chest wall may indeed largely influence values of airways pressions. In contrast, transpulmonary pressure obtained using esophageal pressure (Pes) directly reflect lung overdistension risk and lung properties. In order to better understand this new kind of ARDS characterized by modest recruitable profile and to better personalize mechanical ventilation setting and therapy it is obvious to precise transpulmonary pressure.
- Conditions
- Mechanical Ventilation, SARS-CoV-2, COVID-19
- Keywords
- elastance, Acute respiratory distress syndrome, Esophageal pressure, Pleural pressure
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical Ventilation
Duration of mechanical Ventilation
Measured: 1 day
Secondary outcomes (5)
Number of Participants with during of Acute respiratory distress syndrom (SDRA)
Number of Participants with during of Acute respiratory distress syndrom (SDRA)
Measured: 1 day
Length of stay in intensive care unit
Length of stay in intensive care unit
Measured: 1 day
Mortality
Mortality
Measured: 1 day
number of patients with pulmonary complications
number of patients with pulmonary complications
Measured: 1 day
Number of Participants with pulmonary stress and strain
Number of Participants with pulmonary stress and strain
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramin Séverin, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381286
- Sponsor's protocol ID
- RECHMPL20_0194
- Acronym
- TRANSPULMONARY
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Driving Pressure in ARDS COVID19 Patients / TRANSPULMONARY-COVID19
- ClinicalTrials.gov ID
- NCT04381286
- Acronym / sponsor ID
- TRANSPULMONARY / RECHMPL20_0194
- Conditions
- Mechanical Ventilation, SARS-CoV-2, COVID-19
- Keywords
- elastance, Acute respiratory distress syndrome, Esophageal pressure, Pleural pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 May 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.
A majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed an acute respiratory distress syndrome (ARDS) according to BERLIN criteria. Gattinoni et al. recently described that the ARDS related to SARS-CoV-2 was not a "Typical" ARDS. Patients affected by this infection present indeed a major hypoxemia, which was surprisingly associated in early phase with a high compliance of respiratory system, more than 50 ml/cm H2O in most cases. The cornerstone of current treatment in case of ARDS is the use of "lung protective" ventilation, including limited tidal volumes (VT), low end-inspiratory plateau pressures while maintaining sufficiently-high positive end-expiratory pressures (PEEP). However, high levels of PEEP in patients may have detrimental effects on hemodynamic status and fluid retention, particularly when the respiratory system compliance is normal. High PEEP may also lead to overdistension and an increase of alveolar dead space. The airway pressures commonly monitored does not reliably reflect the impact of pressures on the lung parenchyma. Elastance of chest wall may indeed largely influence values of airways pressions. In contrast, transpulmonary pressure obtained using esophageal pressure (Pes) directly reflect lung overdistension risk and lung properties. In order to better understand this new kind of ARDS characterized by modest recruitable profile and to better personalize mechanical ventilation setting and therapy it is obvious to precise transpulmonary pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with SARS-CoV-2 and mechanical ventilation requirement
Key inclusion criteria (3 listed)
- Major patients (18-90 years old)
- Hospitalized following SARS-CoV-2
- Mechanical ventilatory support
Key exclusion criteria (1 listed)
- Minor patients
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
Duration of mechanical Ventilation
Time frame: 1 day
Duration of mechanical Ventilation
5 secondary outcomes
Number of Participants with during of Acute respiratory distress syndrom (SDRA)
Time frame: 1 day
Length of stay in intensive care unit
Time frame: 1 day
Mortality
Time frame: 1 day
number of patients with pulmonary complications
Time frame: 1 day
Number of Participants with pulmonary stress and strain
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Ramin Séverin, MD principal investigator
University Hospital, Montpellier
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 Mechanical Ventilation and SARS-CoV-2, run by University Hospital, Montpellier 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 1 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 12 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramin Séverin, MD (46733825 ext. 33, s-ramin@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical Ventilation (time frame: 1 day). 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 12 May 2020.