COPD Exacerbation Clinical Trial
— FreeO2 HypHopOfficial title:
Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
NCT number | NCT03835741 |
Other study ID # | 21641 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 17, 2018 |
Est. completion date | June 2026 |
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.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Institut Universitaire de Cardiologie et de Pneumologie de Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Arterial or Capillary blood gaz evolution | Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg) | During hospital stay - From hospital admission until hospital discharge (around one week expected) | |
Other | Hospital Readmission rate after hospital discharge | Rate of hospital readmission after initial hospital discharge | Until day 90 after study inclusion | |
Primary | Hospital length of stay | Duration of the hospital length of stay | From hospital admission until hospital discharge (around one week expected) | |
Secondary | ICU transfer | The rate of ICU admission during hospital stay | During hospital stay : from hospital admission until hospital discharge (around one week expected) | |
Secondary | Oxygen administration duration | The number of days patient receive oxygen supplementation | During hospital stay : from hospital admission until hospital discharge (around one week expected) | |
Secondary | Non invasive or invasive mechanic ventilation rate use | The rate of NIV use during length of stay in hospital | During hospital stay: from hospital admission until hospital discharge (around one week expected) |
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