Finger Cuff Monitoring for High Blood Pressure

Overseen By Cristina Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Pregnancy, Arterial catheter, Raynaud's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new device, VitaWave finger cuffs, can monitor blood pressure more effectively during surgery. It compares the continuous, noninvasive readings of finger cuffs to the interval-based measurements of traditional arm cuffs. Individuals undergoing elective surgeries who already use arm cuffs for blood pressure checks might be suitable candidates. Participants will either continue with the standard arm cuff or use the new finger cuff device during their surgery. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance surgical care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the VitaWave finger cuffs are safe for continuous blood pressure monitoring?

Research has shown that the VitaWave finger cuffs used for continuous blood pressure monitoring are generally safe. One study successfully recorded good quality blood pressure readings in 94% of patients, indicating that the technology works well for most people.

While specific side effects are not detailed, the cuffs are non-invasive, meaning they do not break the skin or enter the body, reducing the risk of complications. The cuffs resemble other widely used finger cuff devices, suggesting they are likely well-tolerated.

Overall, evidence supports the safety of the VitaWave finger cuffs for continuous blood pressure monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VitaWave Finger Cuffs because they offer a continuous, noninvasive way to monitor blood pressure, unlike traditional methods that require intermittent measurements with a cuff around the arm. This new method allows healthcare providers to see real-time blood pressure data without any discomfort to the patient, providing a more accurate and comprehensive picture of a patient's cardiovascular health. By potentially improving how blood pressure is monitored, this technique could lead to better management and treatment of high blood pressure, ultimately improving patient outcomes.

What evidence suggests that the VitaWave finger cuffs are effective for monitoring high blood pressure?

Research has shown that using VitaWave finger cuffs for continuous blood pressure monitoring is reliable. In this trial, participants in Cohort 2 will receive standard care with the addition of continuous non-invasive blood pressure (cNIBP) monitoring using these cuffs, while Cohort 1 will receive standard care with the study device data blinded to the provider. These cuffs track blood pressure in real-time, which proves especially useful during procedures. Studies indicate that this method can be more effective than traditional arm cuffs, which only measure blood pressure at certain intervals. Because the finger cuffs provide constant monitoring, they better track changes in blood pressure during surgery. Early findings suggest these devices could enhance patient safety by providing healthcare providers with immediate information. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

The Continuity Study is for adults over 18 who are scheduled for elective noncardiac surgery and need their blood pressure monitored. They must be in stable physical condition (ASA ≥2) and able to give consent. Pregnant individuals, those with arterial catheters, significant arm blood pressure differences, hand deformities that affect cuff placement, or conditions like Raynaud's disease cannot participate.

Inclusion Criteria

Signed informed consent

ASA Physical Status ≥ 2

I am 18 years old or older.

Exclusion Criteria

Patient who is known to be pregnant

Patient with existing or planned arterial pressure catheter

Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo elective surgery with either intermittent or continuous blood pressure monitoring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Noninvasive Blood Pressure Measurement using VitaWave Finger Cuffs

Trial Overview This study tests new ways of measuring blood pressure continuously during surgery using VitaWave finger cuffs compared to the standard intermittent method with an arm cuff. It aims to see if continuous monitoring offers better information without invasive procedures.

How Is the Trial Designed?

Group I: Cohort 2 - Standard of Care with cNIBP Monitoring Experimental Treatment 1 Intervention

Study device continuous non-invasive blood pressure data are unblinded to the provider

Group II: Cohort 1 - Standard of Care Experimental Treatment 1 Intervention

Study device data are blinded to the provider

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10210402/

A new continuous noninvasive finger cuff device ... A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07216573?term=NA

Study Details | NCT07216573 | The Continuity Study A before & after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous ...

3. bd.com bd.com/content/dam/bd-assets/na/advanced-patient-monitoring/documents/final-for-distribution/education/bd-155216-v2-0-cnibp-white-paper/bd-155216-v2_us_cnibp_white_paper_100225.pdf

Advantages of Continuous Noninvasive Blood Pressure ... noninvasive finger cuffs (Acumen IQ™ Finger Cuff, ClearSight™. Finger Cuff, VitaWave™ Finger Cuff) that continuously monitor a patient's blood pressure.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217315465

Comparison of continuous non-invasive finger arterial ... For a majority of patients undergoing anaesthesia for general surgery, mean arterial pressure (MAP) is only measured intermittently by arm cuff oscillometry ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10842120/

The Promise and Illusion of Continuous, Cuffless Blood ... Cuffless, wearable BP devices offer the promise of beat-to-beat, continuous, noninvasive measurement of BP during both awake and sleep periods with minimal ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0147956323001115

Feasibility of continuous non-invasive finger blood ... Finger blood pressure signals were obtained in 94% of patients. These patients had a high quality blood pressure waveform for 84% of the measurement time.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2963482/

Non-invasive continuous blood pressure monitoring of ... We thought to evaluate feasibility of continuous non-invasive blood pressure monitoring during procedures of interventional electrophysiology.

8. biopac.com biopac.com/product/noninvasive-blood-pressure-system-for-mri/

Noninvasive Blood Pressure System for MRI The NIBP-B-MRI CareTaker VitalStream system measures relative central arterial pressure to provide continuous, noninvasive “Beat-by-Beat” Blood Pressure ...