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

NCT05819164 | Completed

• 1 other identifier: 2023-4002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation; Pneumonia; Hypoxemia; Respiratory Disease

Keywords

oxygen, oximeter

Outcome Measures

Primary Outcomes (1)

• Oxygen flow

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

  assessed up to 10 minutes

Secondary Outcomes (4)

• 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 Arms (5)

88% SpO2 target

EXPERIMENTAL

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

Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter

90% SpO2 target

EXPERIMENTAL

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

Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter

92% SpO2 target

EXPERIMENTAL

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

Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter

94% SpO2 target

EXPERIMENTAL

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

Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter

96% SpO2 target

EXPERIMENTAL

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

Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter

Interventions

Nellcor oximeter DEVICE

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

88% SpO2 target; 90% SpO2 target; 92% SpO2 target; 94% SpO2 target; 96% SpO2 target

Nonin oximeter DEVICE

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

88% SpO2 target; 90% SpO2 target; 92% SpO2 target; 94% SpO2 target; 96% SpO2 target

Masimo oximeter DEVICE

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

88% SpO2 target; 90% SpO2 target; 92% SpO2 target; 94% SpO2 target; 96% SpO2 target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Pneumonia; Hypoxia; Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 19, 2023
• Study Start: May 25, 2023
• Primary Completion: December 5, 2024
• Study Completion: September 25, 2025
• Last Updated: March 9, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)