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

Laval University

Status: Terminated

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

Treatments: Device: FreeO2; Other: manual titration

Study type: Interventional

Funder types: Other

Identifiers

NCT03835741

21641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Automated Oxygen titration

Experimental group

Description:

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

Treatment:

Device: FreeO2

Manual Oxygen titration

Other group

Description:

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

Treatment:

Other: manual titration