Clinical trial NCT03835741: Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
Official title: Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oxygen Toxicity
COPD Exacerbation
Hyperoxia
Hypoxemia
Hypoxic Respiratory Failure
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospital length of stay
timeFrame: From hospital admission until hospital discharge (around one week expected)
Secondary outcomes:
measure: ICU transfer
timeFrame: During hospital stay : from hospital admission until hospital discharge (around one week expected)
measure: Oxygen administration duration
timeFrame: During hospital stay : from hospital admission until hospital discharge (around one week expected)
measure: Non invasive or invasive mechanic ventilation rate use
timeFrame: During hospital stay: from hospital admission until hospital discharge (around one week expected)
Other outcomes:
measure: Arterial or Capillary blood gaz evolution
timeFrame: During hospital stay - From hospital admission until hospital discharge (around one week expected)
measure: Hospital Readmission rate after hospital discharge
timeFrame: Until day 90 after study inclusion
Locations:
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
References: