NIBP Cuff Comparison Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-25

Study Completion Date

2025-06-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to compare NIBP cuff materials and their effect on the measurement results.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement

NCT03054688

Blood Pressure

COMPLETED NA

Somnotouch-NIBP Compared to Standard Ambulatory 24-hours Blood Pressure Measurement

NCT03975582

Blood Pressure

COMPLETED

Wearable Blood Pressure Monitoring

NCT04218032

Blood Pressure

COMPLETED

Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor

NCT02357511

Blood Pressure

COMPLETED NA

Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices

NCT04835857

Hypertension Healthy

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Non-invasive blood pressure measurement is based on the estimation of blood pressure by using cuffs. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. New NIBP standard ISO 81060-2 AMD2 highlights the impact of cuff materials and construction on NIBP clinical accuracy. This study is designed to gather evidence that different cuffs provide equally comparable NIBP measurement results

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Blood Pressure Measurement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age \>= 18 years to 65 years
2. Are able and willing to comply with the study procedures.
3. Are able and willing to provide written informed consent to participate.
4. A cuff of same size is applicable to both arms (difference between the limbs should be less than 2cm)
5. Blood pressure needs to be measurable from both arms.

Exclusion Criteria

1. Are pregnant.
2. Are breastfeeding.
3. Have participated in the study. No subject may participate more than once.
4. Have an AV fistula.
5. Have acute infection.
6. Have subject reported arrythmias.
7. PI or designee decision due to subject health conditions

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes