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

Sponsor

Laval University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05819164

Collaborator

(none)

Enrollment

Arms

19.4

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation Pneumonia Hypoxemia Respiratory Disease	Device: Masimo oximeter Device: Nellcor oximeter Device: Nonin oximeter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Multiple Oxygenation Targets With Different Oximeters in COPD and Non-COPD Patients- Impact on Oxygen Flows

Anticipated Study Start Date :

May 22, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 88% SpO2 target During this periods , oxygen will be administered in manual titration to reach 88% of SpO2.	Device: Masimo oximeter During this period, the Masimo oximeter Radical 7 was used for SpO2 reading Device: Nellcor oximeter During this period, the Nellcor oximeter N-600 was used for SpO2 reading Device: Nonin oximeter During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 90% SpO2 target During this periods , oxygen will be administered in manual titration to reach 90% of SpO2.	Device: Masimo oximeter During this period, the Masimo oximeter Radical 7 was used for SpO2 reading Device: Nellcor oximeter During this period, the Nellcor oximeter N-600 was used for SpO2 reading Device: Nonin oximeter During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 92% SpO2 target During this periods , oxygen will be administered in manual titration to reach 92% of SpO2.	Device: Masimo oximeter During this period, the Masimo oximeter Radical 7 was used for SpO2 reading Device: Nellcor oximeter During this period, the Nellcor oximeter N-600 was used for SpO2 reading Device: Nonin oximeter During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 94% SpO2 target During this periods , oxygen will be administered in manual titration to reach 94% of SpO2.	Device: Masimo oximeter During this period, the Masimo oximeter Radical 7 was used for SpO2 reading Device: Nellcor oximeter During this period, the Nellcor oximeter N-600 was used for SpO2 reading Device: Nonin oximeter During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 96% SpO2 target During this periods , oxygen will be administered in manual titration to reach 96% of SpO2.	Device: Masimo oximeter During this period, the Masimo oximeter Radical 7 was used for SpO2 reading Device: Nellcor oximeter During this period, the Nellcor oximeter N-600 was used for SpO2 reading Device: Nonin oximeter During this period, the Nonin oximeter was used for SpO2 reading

Outcome Measures

Primary Outcome Measures

Oxygen flow [assessed up to 10 minutes]
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 [assessed up to 10 minutes - until SpO2 target stability for 2 minutes]
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 [assessed up to 10 minutes - until SpO2 target stability for 2 minutes]
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 [assessed up to 10 minutes - until SpO2 target stability for 2 minutes]
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 [assessed up to 10 minutes - until SpO2 target stability for 2 minutes]
the mean bias between the result of the different oximeter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Laval University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

François Lellouche, Principal Investigator, Laval University

ClinicalTrials.gov Identifier:

NCT05819164

Other Study ID Numbers:

2023-4002

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 19, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by François Lellouche, Principal Investigator, Laval University

oxygen, oximeter

Additional relevant MeSH terms:

Respiration Disorders

Respiratory Tract Diseases

Hypoxia

Study Results

No Results Posted as of Apr 19, 2023