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

NCT03835741 | Terminated

• 1 other identifier: 21641
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen Toxicity; COPD Exacerbation; Hyperoxia; Hypoxemia; Hypoxic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  Duration of the hospital length of stay

  From hospital admission until hospital discharge (around one week expected)

Secondary Outcomes (3)

• ICU transfer

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

• Oxygen administration duration

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

• Non invasive or invasive mechanic ventilation rate use

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

Other Outcomes (2)

• Arterial or Capillary blood gaz evolution

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

• Hospital Readmission rate after hospital discharge

  Until day 90 after study inclusion

Study Arms (2)

Automated Oxygen titration

EXPERIMENTAL

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

Device: FreeO2

Manual Oxygen titration

OTHER

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

Other: manual titration

Interventions

FreeO2 DEVICE

an automated adjustment of oxygen during patient hospitalisation by FreeO2 device

Automated Oxygen titration

manual titration OTHER

a manual adjustment of oxygen during patient hospitalisation by hospital staff

Manual Oxygen titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Hyperoxia; Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 11, 2019
• Study Start: December 17, 2018
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)