Major Lung ResectionRESECHONCT03032900
Right Ventricular Dysfunction Incidence After Major Lung Resection
An observational study of Major Lung Resection and Right Ventricular Dysfunction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Lung Resection, Right Ventricular Dysfunction
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 2 Jul 2018
- 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: Major lung surgery
Who may be able to join
- Written consent
- Patient older than 18 years
- Major lung surgery (pneumonectomy, lobectomy)
Who cannot join
- Pre-existing pulmonary arteria hypertension
- Post-operative surgical complication on day 1 to 3 (bleeding, revision surgery)
- Technical difficulty preventing adequate echocardiographic assessment
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.
This study aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria.
Read the detailed description
Few clinical trial studied the incidence of right ventricular dysfunction after major lung resection and time frame of occurrence.
In this prospective observational study the right ventricular function will be mesure with echocardiographic criteria. Echocardiographic exam will be standardised and be realised day before surgery (at the same time that inclusion), day 1, day 2 and day 3 after surgery.
In order to assess prognostic value of right dysfunction after lung resection, data as hospitalization stay, complications and survival will be collected at 6 months.
Cardiac cycles will be recorded and be analysed by a single observer blind to the clinical finding and other echocardiographic measurements.
- Keywords
- Major lung resection, Right Ventricular Dysfunction, 2D Strain
- Medical subject headings
- Ventricular Dysfunction, Right
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular dysfunction
Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS > 35mmHg or right ventricular dilatation or right systolic markers abnormalities.
Measured: 5 days
Secondary outcomes (4)
Risk factors
Determining risk factors for developing right ventricular failure after pulmonary resection
Measured: 5 days
Time frame to right ventricular dysfunction
Time frame to right ventricular dysfunction
Measured: 5 days
Assessment of 2D strain for right ventricular dysfunctio
Assessment of 2D strain for right ventricular dysfunction
Measured: 5 days
Estimate impact of right ventricular dysfunction on patient prognosis.
Estimate impact of right ventricular dysfunction on patient prognosis.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Lung ResectionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032900
- Sponsor's protocol ID
- UF9740
- Acronym
- RESECHO
- Status last verified
- Sep 2018
- First submitted
- 16 Jan 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.
- ClinicalTrials.gov ID
- NCT03032900
- Acronym / sponsor ID
- RESECHO / UF9740
- Keywords
- Major lung resection, Right Ventricular Dysfunction, 2D Strain
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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 aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria.
Detailed description
Few clinical trial studied the incidence of right ventricular dysfunction after major lung resection and time frame of occurrence.
In this prospective observational study the right ventricular function will be mesure with echocardiographic criteria. Echocardiographic exam will be standardised and be realised day before surgery (at the same time that inclusion), day 1, day 2 and day 3 after surgery.
In order to assess prognostic value of right dysfunction after lung resection, data as hospitalization stay, complications and survival will be collected at 6 months.
Cardiac cycles will be recorded and be analysed by a single observer blind to the clinical finding and other echocardiographic measurements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major lung surgery
Key inclusion criteria (3 listed)
- Written consent
- Patient older than 18 years
- Major lung surgery (pneumonectomy, lobectomy)
Key exclusion criteria (4 listed)
- Pre-existing pulmonary arteria hypertension
- Post-operative surgical complication on day 1 to 3 (bleeding, revision surgery)
- Technical difficulty preventing adequate echocardiographic assessment
- Patient refusal
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
Right ventricular dysfunction
Time frame: 5 days
Without pre-existing pulmonary arteria hypertension, it will be assess with echocardiography criteria : PAPS > 35mmHg or right ventricular dilatation or right systolic markers abnormalities.
4 secondary outcomes
Risk factors
Time frame: 5 days
Time frame to right ventricular dysfunction
Time frame: 5 days
Assessment of 2D strain for right ventricular dysfunctio
Time frame: 5 days
Estimate impact of right ventricular dysfunction on patient prognosis.
Time frame: 5 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Major Lung Resection and Right Ventricular Dysfunction, 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 4 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: stopped early, as of the sponsor's last update on 14 Sep 2018. 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 was stopped early. Results are not available in the source record.
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?
Right ventricular dysfunction (time frame: 5 days). 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 14 Sep 2018.