FreeDom: Innovative Strategy for the Management of COPD Exacerbations

Laval University

Status: Enrolling

Conditions: Oxygen Deficiency; COPD Exacerbation

Treatments: Other: Control; Device: FreeDom

Study type: Interventional

Funder types: Other

Identifiers

NCT03396172

21419

Details and patient eligibility

About

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.

Full description

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 will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation.

The main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

• Refusal to consent to participate in the study,
• Indication for an imminent intubation according to the pulmonologist,
• Sleep Apnea
• NIV used at home
• Lack of FreeO2 system available at the time of randomization
• Non-autonomous and alone at home
• Patient alone at home
• Patients who live more than 50 km from the hospital
• Patient already included in the study within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control

Other group

Description:

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

Treatment:

Other: Control

FreeDom

Active Comparator group

Description:

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,

Treatment:

Device: FreeDom