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Comparison of Multiple Oxygenation Targets With Different Oximeters in Chronic Obstructive Pulmonary Disease (COPD) and Non-COPD Patients- Impact on Oxygen Flows

Primary Purpose

COPD Exacerbation, Pneumonia, Hypoxemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Masimo oximeter
Nellcor oximeter
Nonin oximeter
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring oxygen, oximeter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 18 years old On conventional oxygen therapy with SpO2 between 88 and 100% with the usual oximeter and nasal cannula. SpO2 < 92% in ambient air with the usual oximeter Exclusion Criteria: No availability of the SpO2 signal with the usual oximeter False nails or nail polish Severe anemia documented on the last blood count during the current hospitalization (Hb < 80g/L)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    88% SpO2 target

    90% SpO2 target

    92% SpO2 target

    94% SpO2 target

    96% SpO2 target

    Arm Description

    During this periods , oxygen will be administered in manual titration to reach 88% of SpO2.

    During this periods , oxygen will be administered in manual titration to reach 90% of SpO2.

    During this periods , oxygen will be administered in manual titration to reach 92% of SpO2.

    During this periods , oxygen will be administered in manual titration to reach 94% of SpO2.

    During this periods , oxygen will be administered in manual titration to reach 96% of SpO2.

    Outcomes

    Primary Outcome Measures

    Oxygen flow
    the mean oxygen flow to reach the SpO2 target +/- 1% during 2 minutes for each period and each oximeter

    Secondary Outcome Measures

    Partial oxygen weaning
    Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) to reach the SpO2 target for each period and each oximeter
    Complete oxygen weaning
    Rate of complete oxygen weaning (Oxygen flow <=0.1 L/min) to reach the SpO2 target for each period and each oximeter
    High oxygen flow
    Rate of high oxygen flow (Oxygen flow >5.0 L/min) to reach the SpO2 target for each period and each oximeter
    Oximeter bias comparison
    the mean bias between the result of the different oximeter

    Full Information

    First Posted
    April 3, 2023
    Last Updated
    April 14, 2023
    Sponsor
    Laval University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05819164
    Brief Title
    Comparison of Multiple Oxygenation Targets With Different Oximeters in Chronic Obstructive Pulmonary Disease (COPD) and Non-COPD Patients- Impact on Oxygen Flows
    Official Title
    Comparison of Multiple Oxygenation Targets With Different Oximeters in COPD and Non-COPD Patients- Impact on Oxygen Flows
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 22, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (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 oximeter is an instrument for monitoring patients receiving oxygen therapy. It displays pulse oxygen saturation (SpO2), which is a reflection of arterial oxygen saturation (SaO2). An accurate SpO2 value is essential for optimal management of the O2 flow delivered to patients. Several factors can influence this measurement and the choice of ventilatory support: the type of oximeter used, skin pigmentation and the oxygenation goal. The objective of our study is to evaluate the impact of the oxygenation goal and the oximeter used on oxygen flows in patients with COPD (or with hypercapnia, or at risk of hypercapnia) and in patients without COPD (in particular pneumonia, pulmonary fibrosis and other pathologies) Our hypothesis is that the SpO2 target and oximeter used will have an impact on oxygen flows and that these effects will be synergistic in these different populations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COPD Exacerbation, Pneumonia, Hypoxemia, Respiratory Disease
    Keywords
    oxygen, oximeter

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    88% SpO2 target
    Arm Type
    Experimental
    Arm Description
    During this periods , oxygen will be administered in manual titration to reach 88% of SpO2.
    Arm Title
    90% SpO2 target
    Arm Type
    Experimental
    Arm Description
    During this periods , oxygen will be administered in manual titration to reach 90% of SpO2.
    Arm Title
    92% SpO2 target
    Arm Type
    Experimental
    Arm Description
    During this periods , oxygen will be administered in manual titration to reach 92% of SpO2.
    Arm Title
    94% SpO2 target
    Arm Type
    Experimental
    Arm Description
    During this periods , oxygen will be administered in manual titration to reach 94% of SpO2.
    Arm Title
    96% SpO2 target
    Arm Type
    Experimental
    Arm Description
    During this periods , oxygen will be administered in manual titration to reach 96% of SpO2.
    Intervention Type
    Device
    Intervention Name(s)
    Masimo oximeter
    Intervention Description
    During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
    Intervention Type
    Device
    Intervention Name(s)
    Nellcor oximeter
    Intervention Description
    During this period, the Nellcor oximeter N-600 was used for SpO2 reading
    Intervention Type
    Device
    Intervention Name(s)
    Nonin oximeter
    Intervention Description
    During this period, the Nonin oximeter was used for SpO2 reading
    Primary Outcome Measure Information:
    Title
    Oxygen flow
    Description
    the mean oxygen flow to reach the SpO2 target +/- 1% during 2 minutes for each period and each oximeter
    Time Frame
    assessed up to 10 minutes
    Secondary Outcome Measure Information:
    Title
    Partial oxygen weaning
    Description
    Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) to reach the SpO2 target for each period and each oximeter
    Time Frame
    assessed up to 10 minutes - until SpO2 target stability for 2 minutes
    Title
    Complete oxygen weaning
    Description
    Rate of complete oxygen weaning (Oxygen flow <=0.1 L/min) to reach the SpO2 target for each period and each oximeter
    Time Frame
    assessed up to 10 minutes - until SpO2 target stability for 2 minutes
    Title
    High oxygen flow
    Description
    Rate of high oxygen flow (Oxygen flow >5.0 L/min) to reach the SpO2 target for each period and each oximeter
    Time Frame
    assessed up to 10 minutes - until SpO2 target stability for 2 minutes
    Title
    Oximeter bias comparison
    Description
    the mean bias between the result of the different oximeter
    Time Frame
    assessed up to 10 minutes - until SpO2 target stability for 2 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥ 18 years old On conventional oxygen therapy with SpO2 between 88 and 100% with the usual oximeter and nasal cannula. SpO2 < 92% in ambient air with the usual oximeter Exclusion Criteria: No availability of the SpO2 signal with the usual oximeter False nails or nail polish Severe anemia documented on the last blood count during the current hospitalization (Hb < 80g/L)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Francois Lellouche
    Phone
    418656-8711
    Ext
    3572
    Email
    francois.lellouche@criucpq.ulaval.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    ierre Alexandre Bouchard
    Phone
    418-656-8711
    Ext
    2712
    Email
    pierre-alexandre.bouchard@criucpq.ulaval.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Multiple Oxygenation Targets With Different Oximeters in Chronic Obstructive Pulmonary Disease (COPD) and Non-COPD Patients- Impact on Oxygen Flows

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