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

Not Applicable

Recruiting

• Conditions: Hypoxemia; Hypoxic Respiratory Failure; Hyperoxia; Oxygen Toxicity; COPD Exacerbation
• Interventions: Device: FreeO2; Other: manual titration

• Registration Number: NCT03835741
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated Oxygen titration	FreeO2	In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
Manual Oxygen titration	manual titration	In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	From hospital admission until hospital discharge (around one week expected)	Duration of the hospital length of stay

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Quebec, Canada