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)

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.

Study Overview

• Status: Unknown
• Conditions: Reperfusion Pulmonary Edema
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Plessis Robinson, France, 92350
    • Recruiting
    • Centre chirurgical Marie Lannelongue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preventive non invasive ventilation; 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).	Other: 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.; Procedure: Non invasive ventilation; Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco); Procedure: Computed tomography (CT)
Other: Non invasive ventilation on demand; 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.	Other: 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.; Procedure: Non invasive ventilation; Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco); Procedure: Computed tomography (CT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung Injury Score.	Daily during hospitalization in the PACU on day 1 to 7.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).	The concentration will be given in pg/mL	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	2 years
Computed tomography (CT) score		2 years
Doppler pulsatility of the portal vein and its pulsatility ratio		2 years
Pulmonary Vascular Index (PVI) measures	PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO	2 years

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: non invasive ventilation; reperfusion pulmonary edema; chronic thrombolic pulmonary hypertension; pulmonary artery angioplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Edema; Pulmonary Edema
• Other Study ID Numbers: 2015-A00399-40