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

Reperfusion Pulmonary Edema Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02548091
• Other study ID #: 2015-A00399-40
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: October 12, 2017
• Start date: February 1, 2016
• Est. completion date: March 2018

Study information

• Verified date: February 2017
• Source: Centre Chirurgical Marie Lannelongue
• Contact: PATRASCU ALINA, MD
• Phone: 01 40 94 25 97
• Email: a.patrascu[@]ccml.fr
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: March 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Edema
• Reperfusion Pulmonary Edema

Intervention

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

• monitoring system Pulse-Induced Contour Cardiac Output (Picco)

• Computed tomography (CT)

Locations

Country	Name	City	State
France	Centre Chirurgical Marie Lannelongue	Le Plessis Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Injury Score.		Daily during hospitalization in the PACU on day 1 to 7.
Secondary	Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).	The concentration will be given in pg/mL	2 years
Secondary	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
Secondary	Computed tomography (CT) score		2 years
Secondary	Doppler pulsatility of the portal vein and its pulsatility ratio		2 years
Secondary	Pulmonary Vascular Index (PVI) measures	PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO	2 years