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

NCT ID: NCT03835741

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2024-07-12

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Automated Oxygen titration

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

Group Type: EXPERIMENTAL

FreeO2

Intervention Type: DEVICE

an automated adjustment of oxygen during patient hospitalisation by FreeO2 device

Manual Oxygen titration

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

Group Type: OTHER

manual titration

Intervention Type: OTHER

a manual adjustment of oxygen during patient hospitalisation by hospital staff

Interventions

FreeO2

an automated adjustment of oxygen during patient hospitalisation by FreeO2 device

Intervention Type: DEVICE

manual titration

a manual adjustment of oxygen during patient hospitalisation by hospital staff

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

François Lellouche

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

21641

Identifier Type: -

Identifier Source: org_study_id