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OpenTrials
Completed

NCT Number: NCT06834516

ClearSight Baby Cuff

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.

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Key information

Conditions

Blood Pressure

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, location AMC

Amsterdam, Netherlands, 1105AZ

About this study

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Age < 2 years
  • Availability of a standard blood pressure measurement as part of standard of care

Exclusion criteria

  • Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
  • Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
  • Known sensitivities to system materials
  • Broken or open skin located at the site of the finger cuff
  • Proven left-right difference in blood pressure
  • Cardiac problems that can cause a difference in blood pressure between the two arms, including aortic coarctation
  • Extreme contraction of the smooth muscles in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease

Treatment and study plan

ClearSight baby cuff

Device

Noninvasive device for continuous blood pressure monitoring

Primary outcomes

  1. Proper cuff fit

    Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure

    The cuff fits properly on the participant's finger in at least 90% of total number of participants. Proper Fit is defined as complete overlap of the hook and loop areas attached to the cuff and the securement flap.

  2. Cuff remains properly fitted for the duration of the study measurement

    Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure

    The cuff remains properly fitted for the duration of the study measurement for at least 90% of total number of participants.

  3. Measurement with monitor started without errors

    Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure

    A measurement can be started without the monitor producing errors and a blood pressure waveform is measured in at least 60% of the attempts, unless the monitor is warning for vaso-constriction.

  4. Measurement stability within 10 mins

    Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure

    The automatic physiological calibration (Physiocal) stabilizes to intervals ≥ 30 beats within 10 minutes in at least 60% of the attempts, indicating measurement stability unless the monitor is warning for vaso-constriction.

  5. Early feasibility accuracy

    Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure

    For systolic blood pressure and diastolic blood pressure the mean value of the errors of all individual paired determinations of the ClearSight versus reference blood pressure shall be within or equal to ±5 mmHg, with a standard deviation, no greater than 8 mmHg.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Early Feasibility Data Collection Using ClearSight on Children Less Than Two Years Old

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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