Reperfusion Pulmonary EdemaOPR_VNINCT02548091
Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
A study testing Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10), Non invasive ventilation and monitoring system Pulse-Induced Contour Cardiac Output (Picco) in people with Reperfusion Pulmonary Edema, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reperfusion Pulmonary Edema
- What is being tested?
- Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10), Non invasive ventilation and monitoring system Pulse-Induced Contour Cardiac Output (Picco)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2016to Mar 2018
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- First and /or second procedure of pulmonary artery angioplasty
- Mean pulmonary arterial pressure ≥ 40 mmHg and/or pulmonary vascular resistance ≥ 8 WU (Wood unit)
- Patient who signed informed consent
- Patients affiliated to a social security program
Who cannot join
- severe neurological disease: Coma Glasgow Scale < 8, severe cognitive decline, postural instability, loss of autonomy.
- psychiatric disease (illness)
- sepsis, severe sepsis and septic shock, according to definitions and diagnostic criteria for sepsis of 'Surviving Sepsis Campaign 2012'
- severe respiratory failure defined by a total lung capacity (TLC)< 50% of the predicted value and/or expiratory volume in 1 second (FEV) < 30% of predicted value
- obstructive sleep apnea syndrome with Continuous Positive Airway treatment
- preexisting hemorrhagic syndrome or coagulation factors deficiency
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- severe renal insufficiency with glomerular filtration rate < 30 ml/min
- severe hepatic failure with hepatic encephalopathy, hemodynamic disorder, decompensates cirrhosis, metabolic disorder( metabolic acidosis, hypoglycemia) hepatorenal syndrome, coagulation disorder (factor V< 50%,disseminated intravascular coagulation)
- patient refusal of participation in the study program
- subjects not affiliated to social security program
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
About this study
Official title: Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.
- Conditions
- Reperfusion Pulmonary Edema
- Being tested
- Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10), Non invasive ventilation, monitoring system Pulse-Induced Contour Cardiac Output (Picco), Computed tomography (CT)
- Keywords
- non invasive ventilation, reperfusion pulmonary edema, chronic thrombolic pulmonary hypertension, pulmonary artery angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)Other
The same amount of blood sample is collected from both arms of study at the same time of the procedure.
In each patient, in the per procedure period, a total of 50 milliliters of blood sample is drawn from the pulmonary circulation downstream and upstream of obstructive lesion, the trunk of pulmonary artery, the superior vena cava and the femoral arterial line prior to angioplasty and at the end of procedure; in the post interventional care unit 10 milliliters of blood sample will be draw daily from the superior vena cava catheter line and femoral arterial line.
Non invasive ventilationProcedure or surgery
monitoring system Pulse-Induced Contour Cardiac Output (Picco)Procedure or surgery
Computed tomography (CT)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Preventive non invasive ventilation | Active comparator | Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU). Receives: Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10); Procedure: Non invasive ventilation; Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco); Procedure: Computed tomography (CT) |
| Non invasive ventilation on demand | Other | Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200. Receives: Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10); Procedure: Non invasive ventilation; Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco); Procedure: Computed tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Injury Score.
Measured: Daily during hospitalization in the PACU on day 1 to 7.
Secondary outcomes (5)
Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).
The concentration will be given in pg/mL
Measured: 2 years
Extravascular Lung Water (EVLW) measures.
EVLW is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO). The unit of EVLW is mL/Kg
Measured: 2 years
Computed tomography (CT) score
Measured: 2 years
Doppler pulsatility of the portal vein and its pulsatility ratio
Measured: 2 years
Pulmonary Vascular Index (PVI) measures
PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start1 Feb 2016
- Primary completionNov 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reperfusion Pulmonary EdemaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548091
- Sponsor's protocol ID
- 2015-A00399-40
- Acronym
- OPR_VNI
- Status last verified
- Feb 2017
- First submitted
- 3 Sep 2015
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02548091
- Acronym / sponsor ID
- OPR_VNI / 2015-A00399-40
- Conditions
- Reperfusion Pulmonary Edema
- Keywords
- non invasive ventilation, reperfusion pulmonary edema, chronic thrombolic pulmonary hypertension, pulmonary artery angioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 14 Sep 2015 (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.
The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive non invasive ventilation | Active comparator | Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10), Procedure: Non invasive ventilation, Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco), Procedure: Computed tomography (CT)Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU). |
| Non invasive ventilation on demand | Other | Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10), Procedure: Non invasive ventilation, Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco), Procedure: Computed tomography (CT)Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- First and /or second procedure of pulmonary artery angioplasty
- Mean pulmonary arterial pressure ≥ 40 mmHg and/or pulmonary vascular resistance ≥ 8 WU (Wood unit)
- Patient who signed informed consent
- Patients affiliated to a social security program
Key exclusion criteria (10 listed)
- severe neurological disease: Coma Glasgow Scale < 8, severe cognitive decline, postural instability, loss of autonomy.
- psychiatric disease (illness)
- sepsis, severe sepsis and septic shock, according to definitions and diagnostic criteria for sepsis of 'Surviving Sepsis Campaign 2012'
- severe respiratory failure defined by a total lung capacity (TLC)< 50% of the predicted value and/or expiratory volume in 1 second (FEV) < 30% of predicted value
- obstructive sleep apnea syndrome with Continuous Positive Airway treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)The same amount of blood sample is collected from both arms of study at the same time of the procedure. In each patient, in the per procedure period, a total of 50 milliliters of blood sample is drawn from the pulmonary circulation downstream and upstream of obstructive lesion, the trunk of pulmonary artery, the superior vena cava and the femoral arterial line prior to angioplasty and at the end of procedure; in the post interventional care unit 10 milliliters of blood sample will be draw daily from the superior vena cava catheter line and femoral arterial line. | Other | Non invasive ventilation on demand, Preventive non invasive ventilation |
| Non invasive ventilation | Procedure or surgery | Non invasive ventilation on demand, Preventive non invasive ventilation |
| monitoring system Pulse-Induced Contour Cardiac Output (Picco) | Procedure or surgery | Non invasive ventilation on demand, Preventive non invasive ventilation |
| Computed tomography (CT) | Procedure or surgery | Non invasive ventilation on demand, Preventive non invasive ventilation |
Primary outcome
Lung Injury Score.
Time frame: Daily during hospitalization in the PACU on day 1 to 7.
5 secondary outcomes
Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).
Time frame: 2 years
Extravascular Lung Water (EVLW) measures.
Time frame: 2 years
Computed tomography (CT) score
Time frame: 2 years
Doppler pulsatility of the portal vein and its pulsatility ratio
Time frame: 2 years
Pulmonary Vascular Index (PVI) measures
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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?
A study testing Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10), Non invasive ventilation and monitoring system Pulse-Induced Contour Cardiac Output (Picco) in people with Reperfusion Pulmonary Edema, run by Centre Chirurgical Marie Lannelongue 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 5 inclusion and 10 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 13 Oct 2017. 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 PATRASCU ALINA, MD (01 40 94 25 97, a.patrascu@ccml.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Injury Score. (time frame: Daily during hospitalization in the PACU on day 1 to 7.). 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 13 Oct 2017.