Informations générales (source: ClinicalTrials.gov)

NCT02548091 Statut inconnu
Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension (OPR_VNI)
Interventional
  • Oedème
  • Hypertension artérielle
  • Hypertension pulmonaire
  • Oedème pulmonaire
N/A
Centre Chirurgical Marie Lannelongue (Voir sur ClinicalTrials)
février 2016
mars 2018
29 juin 2024
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.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CENTRE IMAGERIE MARIE LANNELONGUE En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
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



- 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