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

Last updated: June 17, 2024
Sponsor: Laval University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

manual titration

FreeO2

Clinical Study ID

NCT03835741
21641
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 sputumpurulence,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 baselineflow to maintain SpO2 > or = 92%)

Exclusion

Exclusion Criteria:

  • Patient refusal

  • COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiacpulmonary 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

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: manual titration
Phase:
Study Start date:
December 17, 2018
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Quebec, G1V4G5
    Canada

    Active - Recruiting

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