Informations générales (source: ClinicalTrials.gov)

NCT03221101 En recrutement
Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial (NIVOLD)
Interventional
  • Hypercapnie
  • Bronchopneumopathies obstructives
  • Insuffisance respiratoire
  • Broncho-pneumopathie chronique obstructive
N/A
University Hospital, Rouen (Voir sur ClinicalTrials)
décembre 2011
décembre 2025
29 juin 2024
Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH Dieppe - Dieppe - France Pierre Louis Declercq, MD En recrutement Contact (sur clinicalTrials)
CHU de Rouen - 76000 - Rouen - France Bouchra Lamia, MD, MPH, PhD En recrutement Contact (sur clinicalTrials)
Le Havre, Jacques Monod Hospital - 76290 - Montivilliers - France Clement Medrinal En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH Elbeuf - Elbeuf - France Mahdi Ould, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- COPD patients who survived after an acute episode of hypercapnic respiratory failure

- patients weaned from ventilation ( non invasive ventilation or mechanical
ventilation) prescribed for acute episode since at least five days with following
arterial blood gas : pH > 7.35 and PCO2 > = 45 mmHg


- severe obstructive sleep apnea ( DI > 30/h)

- Non COPD cause of respiratory failure

- Serious comorbidity

- Adverse psychological status