How Differences in Oximeter Performance May Affect Clinical Decision

NCT04474574 | Completed

• 1 other identifier: 2020-01813
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In clinical practice discrepancies between overnight SpO2 recordings performed by 2 devices used simultaneously are regularly observed. However, this has not been systematically studied or quantified. It is therefore important to determine if these discrepancies are anecdotic, or frequent, and to what extent this may affect decisions in clinical practice such as implementing (or withdrawing) oxygen in subjects under noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP), or adjusting NIV settings.

Conditions

Sleep Apnea; Alveolar Hypoventilation; Nocturnal Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Degree of agreement

  The primary endpoint is the degree of agreement between 3 different devices used simultaneously for overnight SpO2 recording for 3 commonly used threshold values defining nocturnal hypoxemia: 5% of time with an SpO2 \< 88%, 10% of time with an SpO2 \< 90% or 20% of time with an SpO2 \< 90%.

  3 months

Secondary Outcomes (4)

• Bland and Altman analysis of agreement

  3 months

• Degree of agreement with threshold values

  3 months

• Minimal SpO2 value

  3 months

• Mean pulse rate

  3 months

Interventions

Simultaneous recording of nocturnal SpO2 DEVICE

The intervention will consist in performing a simultaneous recording of nocturnal SpO2 and pulse rate for at least 4 hours with 3 different devices.

Eligibility Criteria

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

Study Population

Participants will be recruited among 1) hospitalized patients with NIV treatment; 2) ambulatory patients followed for NIV therapy at the outpatient unit of the Division of Pulmonology; 3) patients undergoing an elective polysomnography (sleep study) for adjustment or titration of a positive pressure device (NIV or CPAP) at the Sleep Laboratory of the Division of Pulmonology.

You may qualify if:

• \> 18 years old
• Awake room air SpO2 between 90 and 94%
• NIV or CPAP therapy
• Ambulatory or hospitalized patient in a clinically stable respiratory condition without any vasopressor treatment.

You may not qualify if:

• Hospitalization in an acute care setting (e.g. emergency room, Intensive Care Unit, Intermediate Care Unit)
• Any vasopressor treatment
• Peripheral vascular pathologies that can affect digital perfusion (e.g. history of ischemia, Raynaud's phenomenon, any type of vasculitis).
• Mechanical obstacles that may limit quality of signal (e.g. nail polish, bandage, splint, plaster).
• Patient already treated by long term nocturnal oxygen therapy (LTOT)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

Related Publications (1)

• Karege G, Egger B, Lawi D, Bergeron A, Janssens JP. How Using Different Oximeters May Affect Clinical Decision-Making: A Method Comparison Study in Patients Receiving CPAP or Noninvasive Ventilation. Chest. 2026 Jan;169(1):244-256. doi: 10.1016/j.chest.2025.08.018. Epub 2025 Sep 9.

  PMID: 40930342 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hypoventilation

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 17, 2020
• Study Start: July 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CH (1)