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Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension (OPR_VNI)

Primary Purpose

Reperfusion Pulmonary Edema

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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)

About this trial

This is an interventional prevention trial for Reperfusion Pulmonary Edema focused on measuring non invasive ventilation, reperfusion pulmonary edema, chronic thrombolic pulmonary hypertension, pulmonary artery angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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
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

Sites / Locations

Centre Chirurgical Marie LannelongueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Preventive non invasive ventilation

Non invasive ventilation on demand

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Lung Injury Score.

Secondary Outcome Measures

Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).

The concentration will be given in pg/mL

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

Computed tomography (CT) score

Doppler pulsatility of the portal vein and its pulsatility ratio

Pulmonary Vascular Index (PVI) measures

PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO

Full Information

NCT ID

NCT02548091

First Posted

September 3, 2015

Last Updated

October 12, 2017

Sponsor

Centre Chirurgical Marie Lannelongue

1. Study Identification

Unique Protocol Identification Number

NCT02548091

Brief Title

Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension

Acronym

OPR_VNI

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2016 (Actual)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Chirurgical Marie Lannelongue

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 factor against the development and severity of reperfusion pulmonary edema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Reperfusion Pulmonary Edema

Keywords

non invasive ventilation, reperfusion pulmonary edema, chronic thrombolic pulmonary hypertension, pulmonary artery angioplasty

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preventive non invasive ventilation

Arm Type

Active Comparator

Arm Description

Arm Title

Non invasive ventilation on demand

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Non invasive ventilation

Intervention Type

Procedure

Intervention Name(s)

monitoring system Pulse-Induced Contour Cardiac Output (Picco)

Intervention Type

Procedure

Intervention Name(s)

Computed tomography (CT)

Primary Outcome Measure Information:

Title

Lung Injury Score.

Time Frame

Daily during hospitalization in the PACU on day 1 to 7.

Secondary Outcome Measure Information:

Title

Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).

Description

The concentration will be given in pg/mL

Time Frame

2 years

Title

Extravascular Lung Water (EVLW) measures.

Description

EVLW is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO). The unit of EVLW is mL/Kg

Time Frame

2 years

Title

Computed tomography (CT) score

Time Frame

2 years

Title

Doppler pulsatility of the portal vein and its pulsatility ratio

Time Frame

2 years

Title

Pulmonary Vascular Index (PVI) measures

Description

PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 Exclusion criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

PATRASCU ALINA, MD

Phone

01 40 94 25 97

a.patrascu@ccml.fr

Facility Information:

Facility Name

Centre Chirurgical Marie Lannelongue

City

Le Plessis Robinson

ZIP/Postal Code

92350

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension

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