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

Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

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.

Study Overview

• Status: Terminated
• Conditions: COPD Exacerbation; Hypoxemia; Hyperoxia; Oxygen Toxicity; Hypoxic Respiratory Failure
• Intervention / Treatment: Device: FreeO2; Other: manual titration

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Institut Universitaire De Cardiologie Et De Pneumologie De Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated Oxygen titration; In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device	Device: FreeO2; an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
Other: Manual Oxygen titration; In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff	Other: manual titration; a manual adjustment of oxygen during patient hospitalisation by hospital staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Duration of the hospital length of stay	From hospital admission until hospital discharge (around one week expected)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU transfer	The rate of ICU admission during hospital stay	During hospital stay : from hospital admission until hospital discharge (around one week expected)
Oxygen administration duration	The number of days patient receive oxygen supplementation	During hospital stay : from hospital admission until hospital discharge (around one week expected)
Non invasive or invasive mechanic ventilation rate use	The rate of NIV use during length of stay in hospital	During hospital stay: from hospital admission until hospital discharge (around one week expected)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial or Capillary blood gaz evolution	Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg)	During hospital stay - From hospital admission until hospital discharge (around one week expected)
Hospital Readmission rate after hospital discharge	Rate of hospital readmission after initial hospital discharge	Until day 90 after study inclusion

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Hyperoxia
• Other Study ID Numbers: 21641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No