Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers

NCT04876664 | Unknown

• 1 other identifier: 210080046
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to collect data recorded by devices for cNIBP evaluation purposes.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Data collection of NIBP measurement

  To collect data recorded by devices for cNIBP evaluation purposes.

  through study completion, average of one day

Secondary Outcomes (1)

• Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues

  through study completion, an average of one day

Study Arms (1)

Ambulatory monitoring solution

EXPERIMENTAL

this study has only one arm

Device: measuring blood pressure with noninvasive blood pressure device

Interventions

measuring blood pressure with noninvasive blood pressure device DEVICE

To measure blood pressure in different circumstances with noninvasive blood pressure device

Ambulatory monitoring solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female, aged 18 years or older (≥18 years);
• Willing and able to give informed consent for participation in the study;
• Able and willing to comply with all the study requirements.

You may not qualify if:

• Who is pregnant or lactating;
• Who is a smoker;
• Who has consumed alcohol in the last 24 hours;
• Who has been previously diagnosed with Ataxia or balance disorder;
• Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
• Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker;
• Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;

Sponsors & Collaborators

• GE Healthcare: lead

Study Officials

• Juha Pärkkä

  VTT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juha Pärkkä

CONTACT

+35840-7530525; juha.parkka@vtt.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 6, 2021
• Study Start: June 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: September 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-04