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

NCT ID: NCT05819164

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD Exacerbation Pneumonia Hypoxemia Respiratory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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88% SpO2 target

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

Group Type EXPERIMENTAL

Masimo oximeter

Intervention Type DEVICE

During this period, the Masimo oximeter Radical 7 was used for SpO2 reading

Nellcor oximeter

Intervention Type DEVICE

During this period, the Nellcor oximeter N-600 was used for SpO2 reading

Nonin oximeter

Intervention Type DEVICE

During this period, the Nonin oximeter was used for SpO2 reading

90% SpO2 target

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

Group Type EXPERIMENTAL

Masimo oximeter

Intervention Type DEVICE

During this period, the Masimo oximeter Radical 7 was used for SpO2 reading

Nellcor oximeter

Intervention Type DEVICE

During this period, the Nellcor oximeter N-600 was used for SpO2 reading

Nonin oximeter

Intervention Type DEVICE

During this period, the Nonin oximeter was used for SpO2 reading

92% SpO2 target

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

Group Type EXPERIMENTAL

Masimo oximeter

Intervention Type DEVICE

During this period, the Masimo oximeter Radical 7 was used for SpO2 reading

Nellcor oximeter

Intervention Type DEVICE

During this period, the Nellcor oximeter N-600 was used for SpO2 reading

Nonin oximeter

Intervention Type DEVICE

During this period, the Nonin oximeter was used for SpO2 reading

94% SpO2 target

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

Group Type EXPERIMENTAL

Masimo oximeter

Intervention Type DEVICE

During this period, the Masimo oximeter Radical 7 was used for SpO2 reading

Nellcor oximeter

Intervention Type DEVICE

During this period, the Nellcor oximeter N-600 was used for SpO2 reading

Nonin oximeter

Intervention Type DEVICE

During this period, the Nonin oximeter was used for SpO2 reading

96% SpO2 target

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

Group Type EXPERIMENTAL

Masimo oximeter

Intervention Type DEVICE

During this period, the Masimo oximeter Radical 7 was used for SpO2 reading

Nellcor oximeter

Intervention Type DEVICE

During this period, the Nellcor oximeter N-600 was used for SpO2 reading

Nonin oximeter

Intervention Type DEVICE

During this period, the Nonin oximeter was used for SpO2 reading

Interventions

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Masimo oximeter

During this period, the Masimo oximeter Radical 7 was used for SpO2 reading

Intervention Type DEVICE

Nellcor oximeter

During this period, the Nellcor oximeter N-600 was used for SpO2 reading

Intervention Type DEVICE

Nonin oximeter

During this period, the Nonin oximeter was used for SpO2 reading

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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François Lellouche

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Francois Lellouche

Role: CONTACT

418656-8711 ext. 3572

ierre Alexandre Bouchard

Role: CONTACT

418-656-8711 ext. 2712

Other Identifiers

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2023-4002

Identifier Type: -

Identifier Source: org_study_id

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