Precision in Practice: Parameters Research Laboratory’s Expertise in Dual Auscultation

When it comes to blood pressure validation studies, accuracy is not optional—it’s the foundation. At Parameters Research Laboratory (PRL), we specialize in Dual Auscultation, the gold reference method recognized in ISO 81060-2:2018 / AMD 2:2024 Section 5.2.4.1. This method relies on two trained clinicians simultaneously listening to Korotkoff sounds with a double stethoscope to obtain precise systolic and diastolic readings.

Our performance in this highly specialized technique consistently exceeds industry standards, ensuring our partners receive reliable, regulatory-ready data.

Setting the Bar Higher Than the Standard

At PRL, every clinician undergoes rigorous Blood Pressure Auscultator Training before becoming certified. Our requirements surpass the British Hypertension Society (BHS) standards:

• Training volume: Minimum of 50 supervised blood pressure listens across at least five diverse participants.

• Agreement threshold: ±4 mmHg or better from an expert trainer (BHS allows ±5 mmHg).

• Maximum deviation: No single reading may differ from the trainer by more than 10 mmHg (BHS allows 1 in 50 to exceed).

The result? Our clinicians are not only competent—they are consistently precise.

Unmatched Dual Auscultator Agreement

In our pooled data from multiple studies and training sessions, 99.8% of all paired readings were within the ISO-required ±4 mmHg range for both systolic and diastolic pressure.

Breaking it down:

• ≤2 mmHg difference: ~74% of systolic and ~71% of diastolic readings.

• ≤4 mmHg difference: 99.8% for both measures.

This level of agreement means our observers hear—and record—blood pressure the same way, almost every time. Such consistency is critical for device validation and clinical reliability.

Clinicians using a double stethoscope for dual auscultation in an ISO 81060-2-compliant blood pressure validation study at PRL.

Mastering Hemodynamic Stability – Even Under Induced Change

ISO 81060-2 requires that blood pressure remain stable during measurements, excluding data if variability exceeds 12 mmHg systolic or 8 mmHg diastolic between reference readings.

We tested our ability to maintain stability in two states:

• At rest

• During induced blood pressure elevation via isometric exercise

Results from 89 participants showed that average blood pressure variability was nearly identical in both conditions:

• At Rest: 5.4 mmHg systolic / 4.0 mmHg diastolic

• Induced: 5.3 mmHg systolic / 3.7 mmHg diastolic

Even among participants with significant induced changes (≥15 mmHg systolic or ≥10 mmHg diastolic), variability remained minimal—proving our methodology’s reliability in challenging conditions.

Why This Matters for Blood Pressure Device Validation

Dual Auscultation is the foundation for accurate, reproducible reference readings in both cuff-based and cuffless blood pressure device studies. At PRL, our combination of stringent training, exceptional inter-observer agreement, and control over blood pressure stability ensures that every dataset we produce meets and often exceeds international requirements.

In a field where millimeters matter, PRL delivers results you can trust.

About Parameters Research Laboratory

Parameters Research Laboratory is a leading provider of high-quality clinical data for medical device validation, with a specialization in blood pressure measurement. Our team’s expertise ensures that device manufacturers, researchers, and regulators can rely on our data for confident decision-making. Interested in learning more about how PRL can support your medical device development or validation? Contact us today.

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