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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05819164
• Other study ID #: 2023-4002
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Laval University
• Contact: Francois Lellouche
• Phone: 418656-8711
• Email: francois.lellouche[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD Exacerbation
• Hypoxemia
• Hypoxia
• Pneumonia
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Device:
• Masimo oximeter
During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
• Nellcor oximeter
During this period, the Nellcor oximeter N-600 was used for SpO2 reading
• Nonin oximeter
During this period, the Nonin oximeter was used for SpO2 reading

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Secondary	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	assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Secondary	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	assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Secondary	Oximeter bias comparison	the mean bias between the result of the different oximeter	assessed up to 10 minutes - until SpO2 target stability for 2 minutes