NCT02651558

Brief Summary

Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

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

December 17, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

December 17, 2015

Last Update Submit

April 10, 2018

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter

    The signals recorded by the optical blood pressure device will be retrospectively analysed (offline analysis) in order to test the hypothesis that blood pressure values as derived by the new device is comparable to blood pressure values as measured by an arterial catheter within the limits of agreement in mmHg stated by ISO 81060-2 2013.

    24 months

Study Arms (3)

OBPM 2015-MD-0022 - CHEST

EXPERIMENTAL

Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the chest

Device: Experimental: OBPM 2015-MD-0022 - CHEST

OBPM 2015-MD-0022 - CHEST & FINGER

EXPERIMENTAL

Cohort of 10 patients undergoing general anesthesia, monitored by optical signals at the chest and at the fingertip

Device: Experimental: OBPM 2015-MD-0022 - CHEST & FINGER

OBPM 2015-MD-0022 - FINGER

EXPERIMENTAL

Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the fingertip

Device: Experimental: OBPM 2015-MD-0022 - FINGER

Interventions

Experimental: OBPM 2015-MD-0022 - CHESTDEVICE

At the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.

OBPM 2015-MD-0022 - CHEST
Experimental: OBPM 2015-MD-0022 - CHEST & FINGERDEVICE

At the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) 3. continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.

OBPM 2015-MD-0022 - CHEST & FINGER
Experimental: OBPM 2015-MD-0022 - FINGERDEVICE

At the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.

OBPM 2015-MD-0022 - FINGER

Eligibility Criteria

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

You may qualify if:

  • patient requiring the placement of an arterial catheter for general anesthesia
  • minimum of 18 years
  • written consent

You may not qualify if:

  • minor patient or incapable of discernment
  • patient with AIMD
  • thoracic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, Switzerland

Location

Related Publications (1)

  • Ghamri Y, Proenca M, Hofmann G, Renevey P, Bonnier G, Braun F, Axis A, Lemay M, Schoettker P. Automated Pulse Oximeter Waveform Analysis to Track Changes in Blood Pressure During Anesthesia Induction: A Proof-of-Concept Study. Anesth Analg. 2020 May;130(5):1222-1233. doi: 10.1213/ANE.0000000000004678.

    PMID: 32287129DERIVED

Study Officials

  • Patrick Schoettker

    CHUV

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 17, 2015

First Posted

January 11, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations

CH(1)