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Clinical Trials/NCT05819164
NCT05819164
Completed
Not Applicable

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

Laval University1 site in 1 country40 target enrollmentMay 25, 2023

Overview

Phase
Not Applicable
Intervention
Nellcor oximeter
Conditions
COPD Exacerbation
Sponsor
Laval University
Enrollment
40
Locations
1
Primary Endpoint
Oxygen flow
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2023
End Date
September 25, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

François Lellouche

Principal Investigator

Laval University

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)

Arms & Interventions

90% SpO2 target

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

Intervention: Nellcor oximeter

90% SpO2 target

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

Intervention: Masimo oximeter

90% SpO2 target

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

Intervention: Nonin oximeter

88% SpO2 target

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

Intervention: Masimo oximeter

88% SpO2 target

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

Intervention: Nellcor oximeter

88% SpO2 target

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

Intervention: Nonin oximeter

92% SpO2 target

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

Intervention: Masimo oximeter

92% SpO2 target

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

Intervention: Nellcor oximeter

92% SpO2 target

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

Intervention: Nonin oximeter

94% SpO2 target

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

Intervention: Masimo oximeter

94% SpO2 target

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

Intervention: Nellcor oximeter

94% SpO2 target

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

Intervention: Nonin oximeter

96% SpO2 target

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

Intervention: Masimo oximeter

96% SpO2 target

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

Intervention: Nellcor oximeter

96% SpO2 target

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

Intervention: Nonin oximeter

Outcomes

Primary Outcomes

Oxygen flow

Time Frame: 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 Outcomes

  • Partial oxygen weaning(assessed up to 10 minutes - until SpO2 target stability for 2 minutes)
  • Complete oxygen weaning(assessed up to 10 minutes - until SpO2 target stability for 2 minutes)
  • High oxygen flow(assessed up to 10 minutes - until SpO2 target stability for 2 minutes)
  • Oximeter bias comparison(assessed up to 10 minutes - until SpO2 target stability for 2 minutes)

Study Sites (1)

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