Back to resultsAutomated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop (FreeO2 HypHop)
Primary Purpose
Oxygen Toxicity, COPD Exacerbation, Hyperoxia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FreeO2
manual titration
Sponsored by
About this trial
This is an interventional treatment trial for Oxygen Toxicity
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
Sites / Locations
- Institut Universitaire de Cardiologie et de Pneumologie de QuébecRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Automated Oxygen titration
Manual Oxygen titration
Arm Description
In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff
Outcomes
Primary Outcome Measures
Hospital length of stay
Duration of the hospital length of stay
Secondary Outcome Measures
ICU transfer
The rate of ICU admission during hospital stay
Oxygen administration duration
The number of days patient receive oxygen supplementation
Non invasive or invasive mechanic ventilation rate use
The rate of NIV use during length of stay in hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03835741
Brief Title
Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
Acronym
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Toxicity, COPD Exacerbation, Hyperoxia, Hypoxemia, Hypoxic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Automated Oxygen titration
Arm Type
Experimental
Arm Description
In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
Arm Title
Manual Oxygen titration
Arm Type
Other
Arm Description
In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff
Intervention Type
Device
Intervention Name(s)
FreeO2
Intervention Description
an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
Intervention Type
Other
Intervention Name(s)
manual titration
Intervention Description
a manual adjustment of oxygen during patient hospitalisation by hospital staff
Primary Outcome Measure Information:
Title
Hospital length of stay
Description
Duration of the hospital length of stay
Time Frame
From hospital admission until hospital discharge (around one week expected)
Secondary Outcome Measure Information:
Title
ICU transfer
Description
The rate of ICU admission during hospital stay
Time Frame
During hospital stay : from hospital admission until hospital discharge (around one week expected)
Title
Oxygen administration duration
Description
The number of days patient receive oxygen supplementation
Time Frame
During hospital stay : from hospital admission until hospital discharge (around one week expected)
Title
Non invasive or invasive mechanic ventilation rate use
Description
The rate of NIV use during length of stay in hospital
Time Frame
During hospital stay: from hospital admission until hospital discharge (around one week expected)
Other Pre-specified Outcome Measures:
Title
Arterial or Capillary blood gaz evolution
Description
Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg)
Time Frame
During hospital stay - From hospital admission until hospital discharge (around one week expected)
Title
Hospital Readmission rate after hospital discharge
Description
Rate of hospital readmission after initial hospital discharge
Time Frame
Until day 90 after study inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Lellouche
Phone
4186568711
Ext
3572
Email
francois.lellouche@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Alexandre Bouchard
Phone
4186568711
Ext
2712
Email
pierre-alexandre.bouchard@criucpq.ulaval.ca
Facility Information:
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Lellouche
Email
francois.lellouche@criucpq.ulaval.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
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