NCT04053179

Brief Summary

The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

February 5, 2020

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 6, 2019

Last Update Submit

February 3, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (5)

  • Concordance of blood pressure value measured by 2 different devices after surgery

    Comparison between blood pressure measured by conventional medical monitoring device and by connected patch

    36 hours maximum after the surgery

  • Concordance of heart rate value measured by 2 different devices after surgery

    Comparison between heart rate measured by conventional medical monitoring device and by connected patch

    36 hours maximum after the surgery

  • Concordance of respiratory rate value measured by 2 different devices after surgery

    Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch

    36 hours maximum after the surgery

  • Concordance of arterial oxygen saturation value measured by 2 different devices after surgery

    Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch

    36 hours maximum after the surgery

  • Concordance of temperature value measured by 2 different devices after surgery

    Comparison between temperature measured by conventional medical monitoring device and by connected patch

    36 hours maximum after the surgery

Secondary Outcomes (10)

  • Concordance of blood pressure value measured by 2 different devices during surgery

    During surgery

  • Concordance of heart rate value measured by 2 different devices during surgery

    During surgery

  • Concordance of respiratory rate value measured by 2 different devices during surgery

    During surgery

  • Concordance of arterial oxygen saturation value measured by 2 different devices during surgery

    During surgery

  • Concordance of temperature value measured by 2 different devices during surgery

    During surgery

  • +5 more secondary outcomes

Study Arms (1)

Connected patch validation

EXPERIMENTAL
Device: Patch validation

Interventions

Patch validationDEVICE

Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature

Connected patch validation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient over 18 and under 85 years of age
  • patient requiring general anesthesia for extra-thoracic surgery
  • the patient's position during the operation is in supine position only
  • patient affiliated to or benefiting from social security, excluding State Medical Assistance
  • patient with written consent

You may not qualify if:

  • pregnant or breastfeeding patients
  • patients known to have severe skin reactions to adhésives
  • patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
  • patients deprived of their liberty or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

Study Officials

  • Morgan Le Guen

    Hôpital Foch

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 12, 2019

Study Start

January 1, 2020

Primary Completion

September 4, 2020

Study Completion

September 4, 2020

Last Updated

February 5, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)