Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers

Blood Pressure Clinical Trial

Official title:

Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04876664
• Other study ID #: 210080046
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: April 2021
• Source: GE Healthcare
• Contact: Juha Pärkkä
• Phone: +35840-7530525
• Email: juha.parkka[@]vtt.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: September 1, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• measuring blood pressure with noninvasive blood pressure device
To measure blood pressure in different circumstances with noninvasive blood pressure device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection of NIBP measurement	To collect data recorded by devices for cNIBP evaluation purposes.	through study completion, average of one day
Secondary	Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues	The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues.	through study completion, an average of one day