Status:
COMPLETED
IRAD2 : Patients With Respiratory Failure at Home
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Societe Francophone de Nutrition Enterale et Parenterale
Association ANTADIR ,
Conditions:
Chronic Respiratory Failure
Nutritional Depletion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion. This is a randomized controlled, open clinical trial with two groups. * first...
Detailed Description
Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion State of the art : The IRAD2 trial is evaluating a 3-month home intervention w...
Eligibility Criteria
Inclusion
- well informed and consenting person
- woman is old enough to procreate
- Assisted respiratory treatment at home for 3 months : oxygenotherapy \> 8 hours per day and/or assisted ventilation \> 6 hours per day.
- PaO2 without oxygenotherapy ≤ 8 kPa or 60 mmHg on ambient air at the beginning of assisted respiratory treatment.
- Affection : chronic obstructive bronchopneumopathy, diffuse bronchial dilatation, non neuromuscular restrictive syndrome (pulmonary diffuse infiltration, parietal lesion) obstructive and restrictive syndrome.
- malnourished person, one of following criteria :Body Mass Index ≤ 21kg/m2 or weight loss (10% of the previous weight) or non-fatty mass measured by 50 Hz impedancemetry ≤25th percentiles or ≤ 63% of ideal weight for women, ≤ 67% of ideal weight for men.
Exclusion
- Sleep apnea with daytime drowsiness (drowsiness scale of Epworth \> 9/24)
- Known pathology that reduce the vital prognosis at 6 months (AIDS, cancer...).
- History of hormone dependent cancer ( breast cancer, prostate cancer), pathologic Prostate Specific Antigen.
- Inability to follow a rehabilitation program
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00230984
Start Date
April 1 2003
End Date
June 1 2008
Last Update
July 8 2009
Active Locations (8)
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1
University Hospital Dominique Larrey
Limoges, France, 87042
2
Rehabilitation Department of Cyr Voisin
Loos, France, 59374
3
University Hospital Arnaud de Villeneuve
Montpellier, France, 34295
4
Hospital la Pitiè-Salpétrière
Paris, France, 75000