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

NCT ID: NCT03054688

Last Updated: 2018-06-15

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2018-04-01

Brief Summary

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Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Somnotouch NIBP

Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device

Group Type EXPERIMENTAL

Somnotouch NIBP

Intervention Type DEVICE

Somnotouch NIBP in addition to standard blood pressure measurement

Interventions

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Somnotouch NIBP

Somnotouch NIBP in addition to standard blood pressure measurement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Able to give informed consent

Exclusion Criteria

* Atrial fibrillation
* Medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thilo Burkard, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Philipp Krisai, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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Derendinger FC, Vischer AS, Krisai P, Socrates T, Schumacher C, Mayr M, Burkard T. Ability of a 24-h ambulatory cuffless blood pressure monitoring device to track blood pressure changes in clinical practice. J Hypertens. 2024 Apr 1;42(4):662-671. doi: 10.1097/HJH.0000000000003667. Epub 2024 Jan 23.

Reference Type DERIVED
PMID: 38288945 (View on PubMed)

Krisai P, Vischer AS, Kilian L, Meienberg A, Mayr M, Burkard T. Accuracy of 24-hour ambulatory blood pressure monitoring by a novel cuffless device in clinical practice. Heart. 2019 Mar;105(5):399-405. doi: 10.1136/heartjnl-2018-313592. Epub 2018 Sep 18.

Reference Type DERIVED
PMID: 30228251 (View on PubMed)

Other Identifiers

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03061989

Identifier Type: -

Identifier Source: org_study_id

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