Recruiting

FreeDom

Sponsor:

Laval University

Code:

NCT03396172

Conditions

Oxygen Deficiency

COPD Exacerbation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Control

FreeDom

Study Details

Brief 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.

Conditions

Oxygen Deficiency

COPD Exacerbation

Study ID

NCT03396172

Start date

May 24, 2018

Status verified date

Jun, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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,

Interventions

Control

The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria

FreeDom

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

Primary outcome measure

  • The number of hospital days during COPD exacerbation at day 30. [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

François Lellouche

418-656-8711francois.lellouche@criucpq.ulaval.ca

Pierre-alexandre Bouchard

418-656-8711pierre-alexandre.bouchard@criucpq.ulaval.ca

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Quebec, Canada, G1V4G5

Contacts

Francois Lellouche

francois.lellouche@criucpq.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Keywords

  • COPD
  • Homecare
  • Oxygen
  • Telemedicine
  • Automated oxygen adjustment
  • Rehabilitation program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2024-06-18.