ThoracicARDS_THONCT04818554
Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery
An observational study of Thoracic and Pulmonary Restrictive Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The improvement in ARDS mortality over the last 20 years seems to be largely explained by the reduction of mechanical ventilation-induced injury (VILI). VILI is essentially related to volotrauma closely associated with "strain" and "stress". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic, Pulmonary Restrictive Disease, ARDS
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with ARDS hospitalized in the DAR ADV intensive care unit after thoracic resection surgery
Who may be able to join
- Patient hospitalized following ARDS after thoracic resection surgery
Who cannot join
- Refusal to participate after receiving the information letter
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
hélène David, PhD, 629834346 ext. 33, h-david@chu-montpellier.fr
About this study
The improvement in ARDS mortality over the last 20 years seems to be largely explained by the reduction of mechanical ventilation-induced injury (VILI). VILI is essentially related to volotrauma closely associated with "strain" and "stress". The pulmonary stress corresponds to the transpulmonary pressure (alveolar pressure - pleural pressure), and the strain to the change in lung volume related to the functional residual capacity (FRC) of the injured lung at PEEP = 0. The volotrauma corresponds therefore to the generalized excess of stress and strain on the injured lung.
The initial therapeutic strategy consists in protective ventilation with a tidal volume of 6 ml/kg of theoretical ideal weight (predicted by height), associated with a high respiratory rate between 25 and 30 cycles per minute to control PaCO2 (< 50 mmHg), apply a high positive expiratory pressure PEEP according to FiO2, maintain a plateau pressure (PP) lower than 30 cmH20, reduce instrumental dead space, use curarization, recruitment maneuvers such as alternate prone, improve ventilation-perfusion adequacy using inhaled NO.
Read more
As a last resort, extracorporeal oxygenation by veno-venous ECMO is a device to supplement respiratory function by improving oxygenation and ensuring decarboxylation. Veno-venous ECMO is indicated in severe ARDS with PaO2/FiO2 < 80 mmHg and/or when mechanical ventilation becomes unsafe due to increased plateau pressure despite optimized ARDS management including high PEEP levels, curarization and prone position.
After lung resection surgery, the incidence of ARDS is 2-8% and its prognosis remains more poor, despite advances in management, with a mortality of up to 60%. Risk factors include intraoperative vascular filling, type of pulmonary resection, and predicted postoperative respiratory function. Early support with VV ECMO is vital in some patients to treat severe hypoxemia, due to variable surgical reduction of lung parenchyma depending on carcinological involvement or initial lung pathology. ). There are very few data concerning these patients with pulmonary resection. The primary objective of this study is to describe the prevalence of ARDS and the risk factors for its occurrence after pulmonary resection surgery. The secondary objective is to compare the ventilation parameters (especially motor pressure) in patients with reduced lung parenchyma in ARDS under VV ECMO with those who did not use VV ECMO assistance.
- Conditions
- Thoracic, Pulmonary Restrictive Disease, ARDS
- Keywords
- Thoracic surgery, ARDS, Pulmonary resection, Ventilation
- Medical subject headings
- Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ARDS
Prevalence of ARDS after pulmonary resection surgery
Measured: 1 day
risk factors for its occurrence after pulmonary resection surgery
risk factors for its occurrence after pulmonary resection surgery
Measured: 1 day
Secondary outcomes (1)
According to the usual clinico-biological data of monitoring in intensive care
According to the usual clinico-biological data of monitoring in intensive care
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 posted26 Mar 2021
- Study start1 Jan 2012
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hélène David, PHD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818554
- Sponsor's protocol ID
- RECHMPL21_0191
- Acronym
- ARDS_THO
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 30 Mar 2021
- 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 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery
- ClinicalTrials.gov ID
- NCT04818554
- Acronym / sponsor ID
- ARDS_THO / RECHMPL21_0191
- Conditions
- Thoracic, Pulmonary Restrictive Disease, ARDS
- Keywords
- Thoracic surgery, ARDS, Pulmonary resection, Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 26 Mar 2021 (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 improvement in ARDS mortality over the last 20 years seems to be largely explained by the reduction of mechanical ventilation-induced injury (VILI). VILI is essentially related to volotrauma closely associated with "strain" and "stress". The pulmonary stress corresponds to the transpulmonary pressure (alveolar pressure - pleural pressure), and the strain to the change in lung volume related to the functional residual capacity (FRC) of the injured lung at PEEP = 0. The volotrauma corresponds therefore to the generalized excess of stress and strain on the injured lung.
The initial therapeutic strategy consists in protective ventilation with a tidal volume of 6 ml/kg of theoretical ideal weight (predicted by height), associated with a high respiratory rate between 25 and 30 cycles per minute to control PaCO2 (< 50 mmHg), apply a high positive expiratory pressure PEEP according to FiO2, maintain a plateau pressure (PP) lower than 30 cmH20, reduce instrumental dead space, use curarization, recruitment maneuvers such as alternate prone, improve ventilation-perfusion adequacy using inhaled NO.
As a last resort, extracorporeal oxygenation by veno-venous ECMO is a device to supplement respiratory function by improving oxygenation and ensuring decarboxylation. Veno-venous ECMO is indicated in severe ARDS with PaO2/FiO2 < 80 mmHg and/or when mechanical ventilation becomes unsafe due to increased plateau pressure despite optimized ARDS management including high PEEP levels, curarization and prone position.
After lung resection surgery, the incidence of ARDS is 2-8% and its prognosis remains more poor, despite advances in management, with a mortality of up to 60%. Risk factors include intraoperative vascular filling, type of pulmonary resection, and predicted postoperative respiratory function. Early support with VV ECMO is vital in some patients to treat severe hypoxemia, due to variable surgical reduction of lung parenchyma depending on carcinological involvement or initial lung pathology. ). There are very few data concerning these patients with pulmonary resection. The primary objective of this study is to describe the prevalence of ARDS and the risk factors for its occurrence after pulmonary resection surgery. The secondary objective is to compare the ventilation parameters (especially motor pressure) in patients with reduced lung parenchyma in ARDS under VV ECMO with those who did not use VV ECMO assistance.
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
- Patient with ARDS hospitalized in the DAR ADV intensive care unit after thoracic resection surgery
Key inclusion criteria (1 listed)
- Patient hospitalized following ARDS after thoracic resection surgery
Key exclusion criteria (1 listed)
- Refusal to participate after receiving the information letter
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
Prevalence of ARDS
Time frame: 1 day
Prevalence of ARDS after pulmonary resection surgery
risk factors for its occurrence after pulmonary resection surgery
Time frame: 1 day
risk factors for its occurrence after pulmonary resection surgery
1 secondary outcome
According to the usual clinico-biological data of monitoring in intensive care
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 30 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Thoracic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
hélène David, PHD study director
UH 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 Thoracic and Pulmonary Restrictive Disease, 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 1 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 30 Mar 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 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 Hélène David, PHD (629834346 ext. 33, h-david@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ARDS (time frame: 1 day). The study lists 2 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 30 Mar 2021.