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TerminatedNCT03835741FreeO2 HypHopUpdated Sep 4, 2025

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

An interventional study of FreeO2 and manual titration in Oxygen Toxicity, COPD Exacerbation and Hyperoxia, sponsored by Laval University. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Laval University · Not applicable, Interventional, and Treatment

Why this study was terminated
The clinical implementation of the system used in the study as well as its routine use limited the possibilities of carrying out this project.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.

Read the detailed description

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.

Patients with severe acute exacerbation of COPD requiring hospitalization will be included in this randomized controlled study and will be managed with either manual oxygen titration or automated oxygen titration (FreeO2 arm).

The impact on the hospital length of stay will be evaluated.

02

Conditions studied

  • Oxygen Toxicity
  • COPD Exacerbation
  • Hyperoxia
  • Hypoxemia
  • Hypoxic Respiratory Failure
03

In context

Hyperoxia

115 studies on the registry are indexed under Hyperoxia; 13 are open to participants now.

This study's enrollment of 17 is below the median of 48 across 82 interventional studies indexed under Hyperoxia.

Browse Hyperoxia studies →

Lead sponsor

Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion Criteria:

  • Patient refusal
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Automated Oxygen titration

    In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device

    Device: FreeO2

  • Other
    Manual Oxygen titration

    In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff

    Other: manual titration

Interventions

  • DeviceFreeO2

    an automated adjustment of oxygen during patient hospitalisation by FreeO2 device

  • Othermanual titration

    a manual adjustment of oxygen during patient hospitalisation by hospital staff

06

What researchers measure

Primary outcomes

  1. Hospital length of stay

    Duration of the hospital length of stay

    Time frame: From hospital admission until hospital discharge (around one week expected)

Secondary outcomes

  1. ICU transfer

    The rate of ICU admission during hospital stay

    Time frame: During hospital stay : from hospital admission until hospital discharge (around one week expected)

  2. Oxygen administration duration

    The number of days patient receive oxygen supplementation

    Time frame: During hospital stay : from hospital admission until hospital discharge (around one week expected)

  3. Non invasive or invasive mechanic ventilation rate use

    The rate of NIV use during length of stay in hospital

    Time frame: During hospital stay: from hospital admission until hospital discharge (around one week expected)

Other outcomes

  1. Arterial or Capillary blood gaz evolution

    Evaluation of the rate of respiratory acidosis (pH\<7.35 and PaCO2\>45mmHg)

    Time frame: During hospital stay - From hospital admission until hospital discharge (around one week expected)

  2. Hospital Readmission rate after hospital discharge

    Rate of hospital readmission after initial hospital discharge

    Time frame: Until day 90 after study inclusion

07

Study locations

1 site
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec
    Québec, Quebec G1V4G5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03835741
Lead sponsor
Laval University
Responsible party
François Lellouche (Principal Investigator, Laval University) — Principal investigator
First posted
Feb 11, 2019
Start date
Dec 17, 2018
Primary completion
Jul 12, 2024
Completion
Jul 12, 2024
Last update
Sep 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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