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Search / Trial NCT03835741

Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

Launched by LAVAL UNIVERSITY · Feb 7, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The FreeO2 HypHop clinical trial is studying whether a new device, called FreeO2, can automatically adjust the amount of oxygen given to patients experiencing a flare-up of chronic obstructive pulmonary disease (COPD). The goal is to see if using this device can help patients leave the hospital sooner compared to the traditional method of adjusting oxygen levels by hand. This trial is currently looking for participants aged 65 to 74 who have a history of COPD and are experiencing increased breathing difficulties.

To be eligible for the study, participants should have been diagnosed with COPD or suspected COPD, and they need to show signs of a recent worsening in their symptoms, such as more trouble breathing or changes in their sputum (the mucus they cough up). Patients who are interested should know that they will be monitored closely during the trial and will have their oxygen levels adjusted automatically or manually, depending on which group they are placed in. This trial aims to improve care for COPD patients, so if you or someone you know fits the criteria, it might be worth considering participation.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • COPD or suspected COPD ( Age\>40, active or smoking history \> 10pack/years), -
  • Acute exacerbation (increasing dyspnea recently)
  • One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea,
  • Moderate oxygen therapy: Oxygen flow \< 8 lpm (or FiO2 \< 0.60) to maintain a SpO2 \>or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 \> or = 92%)
  • Exclusion Criteria:
  • Patient refusal
  • COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose
  • No SpO2 signal
  • Encephalopathy score \> 2
  • Delirium
  • Other respiratory support needed (intubation or NIV)
  • Patient on withdrawal life support
  • Advance neoplasia (palliative stage) or terminal respiratory distress
  • Unavailability of FreeO2 device at the randomisation
  • Non optimal patient collaboration

About Laval University

Laval University is a prestigious research institution located in Quebec, Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. The university actively engages in clinical trials aimed at exploring new therapeutic interventions and improving patient outcomes. With a strong emphasis on ethical standards and rigorous scientific methodologies, Laval University collaborates with multidisciplinary teams of researchers, healthcare professionals, and industry partners to conduct high-quality clinical research. Its state-of-the-art facilities and dedication to fostering a culture of inquiry position Laval University as a leader in clinical research, contributing significantly to the understanding and treatment of diverse medical conditions.

Locations

Quebec, , Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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