NCT03514173

Brief Summary

The subject of the observation study with accompanying employee survey is the evaluation of a patient remote monitoring system (Vital Sync from Medtronic, hereinafter abbreviated as "Vital Sync") in intensive care medicine. The aim of this research project is to determine whether the use of Vital Sync on an intensive care unit is accepted by medical and nursing staff and can be integrated into everyday work as an additional visualisation and analysis tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

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

March 27, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

March 27, 2018

Last Update Submit

February 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptance of Remote Patient Monitoring Device on Intensive Care Unit

    Acceptance of Remote Patient Monitoring Device (measured by the Likert scale on the question "What was the benefit of the new system for you?" 0=no benefit; 5=very high benefit)

    One year

Secondary Outcomes (10)

  • Structural Data of Intensive Care Unit

    One year

  • Structural Data of Intensive Care Unit

    One year

  • Structural Data of Intensive Care Unit

    One year

  • Structural Data of Intensive Care Unit

    One year

  • Structural Data of Intensive Care Unit

    One year

  • +5 more secondary outcomes

Interventions

Use of remote patient monitoring

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From the Department for Anaesthesiology and operative Intensive Care, Charité - Universitätsmedizin Berlin, Campus Virchow- Klinikum and Campus Charité Mitte, Germany * physicians * specialist nurses * respiratory therapists or respiratory therapists

You may qualify if:

  • From the Department for Anaesthesiology and operative Intensive Care, Charité - Universitätsmedizin Berlin, Campus Virchow- Klinikum and Campus Charité Mitte, Germany
  • physicians
  • specialist nurses
  • respiratory therapists or respiratory therapists

You may not qualify if:

  • Rejection of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin, Klinik für Anästhesiologie m.S. operative Intensivmedizin

Berlin, 10117, Germany

Location

Related Publications (5)

  • Balzer F, Agha-Mir-Salim L, Ziemert N, Schmieding M, Mosch L, Prendke M, Wunderlich MM, Memmert B, Spies C, Poncette AS. Staff perspectives on the influence of patient characteristics on alarm management in the intensive care unit: a cross-sectional survey study. BMC Health Serv Res. 2023 Jul 5;23(1):729. doi: 10.1186/s12913-023-09688-x.

  • Mosch LK, Poncette AS, Spies C, Weber-Carstens S, Schieler M, Krampe H, Balzer F. Creation of an Evidence-Based Implementation Framework for Digital Health Technology in the Intensive Care Unit: Qualitative Study. JMIR Form Res. 2022 Apr 8;6(4):e22866. doi: 10.2196/22866.

  • Poncette AS, Mosch LK, Stablo L, Spies C, Schieler M, Weber-Carstens S, Feufel MA, Balzer F. A Remote Patient-Monitoring System for Intensive Care Medicine: Mixed Methods Human-Centered Design and Usability Evaluation. JMIR Hum Factors. 2022 Mar 11;9(1):e30655. doi: 10.2196/30655.

  • Poncette AS, Mosch L, Spies C, Schmieding M, Schiefenhovel F, Krampe H, Balzer F. Improvements in Patient Monitoring in the Intensive Care Unit: Survey Study. J Med Internet Res. 2020 Jun 19;22(6):e19091. doi: 10.2196/19091.

  • Poncette AS, Spies C, Mosch L, Schieler M, Weber-Carstens S, Krampe H, Balzer F. Clinical Requirements of Future Patient Monitoring in the Intensive Care Unit: Qualitative Study. JMIR Med Inform. 2019 Apr 30;7(2):e13064. doi: 10.2196/13064.

Study Officials

  • Felix Balzer, Prof.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2018

First Posted

May 2, 2018

Study Start

April 4, 2018

Primary Completion

July 28, 2020

Study Completion

December 31, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations