ARDS Due to Disease Caused by SARS Co-V-2COMPLI-QUONCT05721768
Altered Respiratory Compliance Under Invasive Mechanical Ventilation in SARS-CoV-2 & Development of Respiratory Sequels
An observational study of ARDS Due to Disease Caused by SARS Co-V-2 and Respiratory Compliance, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The goal is to study the association between the value of the compliance of the respiratory system at the first day of the initiation of invasive mechanical ventilation and the presence of respiratory sequelae at a distance from the COVID-19 infection with the hypothesis that patients who have presented an alteration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS Due to Disease Caused by SARS Co-V-2, Respiratory Compliance, Sequels of COVID
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2023to 1 Jul 2023
- 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: Patients followed in the Outpatient Medicine Unit of the Respiratory Department of the Nancy University Hospital in the framework of the post COVID-19 follow-up, previously hospitalized in intensive care medicine and intensive care unit.
Who may be able to join
- Hospitalized in intensive care medicine between 01/03/2030 and 01/09/2022 (with invasive mechanical ventilation for at least 48 hours for a SARS-CoV-2 infection documented by RT-PCR) who were followed in pulmonary outpatient medicine at least 3 months after their hospitalization in intensive care medicine and before 01/12/2022 and who had respiratory sequelae during this period.
- Hospitalized in intensive care medicine between 01/03/2020 and 01/12/2021 (with invasive mechanical ventilation for at least 48 hours for SARS-CoV-2 infection documented by RT-PCR) who were followed up in pulmonary outpatient medicine but did not have respiratory sequelae between 01/06/2020 and 01/12/2022.
Who cannot join
- Documented underlying respiratory pathology.
- Pneumothorax within the first 10 days.
- Patient requiring extracorporeal circulatory support.
- Refusal to participate
- Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code: Pregnant woman, parturient or breastfeeding mother / Minor (not emancipated) / Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) / Adult unable to express his consent
- Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
- Respiratory system compliance data not available on the computer software
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Valentin Simon
Nancy, 54000
valentin simon, 0686435505, simon1.valentin1@gmail.com
About this study
The goal is to study the association between the value of the compliance of the respiratory system at the first day of the initiation of invasive mechanical ventilation and the presence of respiratory sequelae at a distance from the COVID-19 infection with the hypothesis that patients who have presented an alteration of the compliance of the respiratory system are at greater risk of developing respiratory sequelae.
Studying the altered compliance of the respiratory system in ARDS secondary to COVID-19 and its relationship to the development of respiratory sequelae would help us to improve the management of patients with COVID-19.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of respiratory sequelae
Presence of respiratory sequelae (FVC <80% or DLCO <70% or radiologic sequelae attributable to SARS-CoV-2) at M3 or M6 or M12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start24 Feb 2023
- Primary completion15 Mar 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS Due to Disease Caused by SARS Co-V-2Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon VALENTIN, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721768
- Sponsor's protocol ID
- 2022PI195
- Acronym
- COMPLI-QUO
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Respiratory Compliance Under Invasive Mechanical Ventilation in SARS-CoV-2 & Development of Respiratory Sequels
- ClinicalTrials.gov ID
- NCT05721768
- Acronym / sponsor ID
- COMPLI-QUO / 2022PI195
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 10 Feb 2023 (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.
The goal is to study the association between the value of the compliance of the respiratory system at the first day of the initiation of invasive mechanical ventilation and the presence of respiratory sequelae at a distance from the COVID-19 infection with the hypothesis that patients who have presented an alteration of the compliance of the respiratory system are at greater risk of developing respiratory sequelae.
Studying the altered compliance of the respiratory system in ARDS secondary to COVID-19 and its relationship to the development of respiratory sequelae would help us to improve the management of patients with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in the Outpatient Medicine Unit of the Respiratory Department of the Nancy University Hospital in the framework of the post COVID-19 follow-up, previously hospitalized in intensive care medicine and intensive care unit.
Key inclusion criteria (2 listed)
- Hospitalized in intensive care medicine between 01/03/2030 and 01/09/2022 (with invasive mechanical ventilation for at least 48 hours for a SARS-CoV-2 infection documented by RT-PCR) who were followed in pulmonary outpatient medicine at least 3 months after their hospitalization in intensive care medicine and before 01/12/2022 and who had respiratory sequelae during this period.
- Hospitalized in intensive care medicine between 01/03/2020 and 01/12/2021 (with invasive mechanical ventilation for at least 48 hours for SARS-CoV-2 infection documented by RT-PCR) who were followed up in pulmonary outpatient medicine but did not have respiratory sequelae between 01/06/2020 and 01/12/2022.
Key exclusion criteria (7 listed)
- Documented underlying respiratory pathology.
- Pneumothorax within the first 10 days.
- Patient requiring extracorporeal circulatory support.
- Refusal to participate
- Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code: Pregnant woman, parturient or breastfeeding mother / Minor (not emancipated) / Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) / Adult unable to express his consent
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
Presence of respiratory sequelae
Time frame: 1 year
Presence of respiratory sequelae (FVC <80% or DLCO <70% or radiologic sequelae attributable to SARS-CoV-2) at M3 or M6 or M12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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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.
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 ARDS Due to Disease Caused by SARS Co-V-2 and Respiratory Compliance, run by Central Hospital, Nancy, France 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 2 inclusion and 7 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 28 Feb 2023. 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 simon valentin, MD (+3383153405, simon.valentin@live.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of respiratory sequelae (time frame: 1 year). 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 28 Feb 2023.