NCT02357511

Brief Summary

The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

January 22, 2015

Last Update Submit

July 28, 2015

Conditions

Blood Pressure

Keywords

sensitivityspecificitynovel blood pressure monitorSaturation

Outcome Measures

Primary Outcomes (1)

  • Relationship between invasive and noninvasive blood pressure measurement

    comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement

    2 hours of continuous measurement at PACU

Secondary Outcomes (1)

  • Relationship between study monitor Sp02 measurement and current sp02 measurement

    2 hours of continuous measurement at PACU

Study Arms (1)

Study goup

EXPERIMENTAL

Vital values are being measured for the time of two hours at postoperative setting at postanesthesia care unit. A novel method is compared to golden standard: invasive measurement. Also Saturation measurements are being compared between standard and study monitor.

Device: Study Monitor used

Interventions

Study Monitor usedDEVICE
Study goup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjected to operative treatment with the need for invasive blood pressure measurement
  • spontaneous ventilation
  • able to give informed consent

You may not qualify if:

  • denial by patient
  • pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Arvi Yli-Hankala, Professor

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 6, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

FI(1)