FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The main objective of the study is to assess the FreeDom innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation. The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ All patients hospitalized for COPD exacerbation for less than 48 hours will be considered.

• known or suspected COPD to entry

• Age \> or = 40 years

• Ex-smoker history (10 pack / year or more)

• Acute Exacerbation: dyspnea of recent onset (less than 15 days)

• The need for oxygen therapy with a moderate rate: \<6L / min to maintain SpO2 \> 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)

Locations
Other Locations
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
RECRUITING
Québec
Contact Information
Primary
François Lellouche
francois.lellouche@criucpq.ulaval.ca
418-656-8711
Backup
Pierre-alexandre Bouchard
pierre-alexandre.bouchard@criucpq.ulaval.ca
418-656-8711
Time Frame
Start Date: 2018-05-24
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Other: Control
The intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
Active_comparator: FreeDom
FreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation):~-initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met.~After hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization,
Sponsors
Leads: Laval University

This content was sourced from clinicaltrials.gov