Postoperative continuous telemonitoring at the surgical ward

ISRCTN	ISRCTN75034369
DOI	https://doi.org/10.1186/ISRCTN75034369
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	202000231
Sponsor	University Medical Center Groningen
Funder	Stichting Lijf en Leven

Submission date: 11/07/2023
Registration date: 03/11/2023
Last edited: 31/05/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Telemonitoring, a sub-category of eHealth, may play a role in the early detection of postoperative deterioration, lower workload for nurses and facilitate the migration of care towards home. Wearable sensors are available for the continuous monitoring of vital signs, including skin temperature, heart rate, respiratory rate, blood oxygenation, and activity parameters. It is still unknown, however, how to incorporate continuous telemonitoring in the perioperative trajectory of surgical patients. As a pilot for further trials, the aim of this study is to assess the feasibility and applicability of telemonitoring by continuous monitoring of vital signs and physical activity of patients at the post-anesthesia care unit (PACU) and a surgical ward.

Who can participate?
Patients aged 18 years or older admitted to the surgical ward and planned for surgery with an expected postoperative stay of 48 hours

What does the study involve?
During a period of 3 months patients receive standard care and wear two wearable sensors for continuous monitoring. No medical decisions will be made using the data collected by the telemonitoring devices.

What are the possible benefits and risks of participating?
The burden of this study is low. Patients receive extra monitoring by wearing two sensors during their postoperative hospital stay. Patients are not expected to experience physical, psychological or mental strain due to the monitoring. All measurements are safe and non-invasive.

Where is the study run from?
University Medical Center Groningen (Netherlands)

When is the study starting and how long is it expected to run for?
June 2021 to December 2025

Who is funding the study?
Stichting Lijf & Leven (Netherlands)

Who is the main contact?
1. Rianne van Melzen, r.van.melzen@umcg.nl
2. Marjolein Haveman, m.e.haveman@umcg.nl
3. Prof. Dr. Jean-Paul de Vries

Contact information

Mrs Rianne van Melzen
Scientific

Hanzeplein 1
Groningen
9713 GZ
Netherlands

ORCID ID	0000-0003-0919-6532
Phone	+31 (0)625651391
Email	r.van.melzen@umcg.nl

Dr Marjolein Haveman
Scientific

Hanzeplein 1
Groningen
9713 GZ
Netherlands

ORCID ID	0000-0002-6030-3172
Phone	+31 (0)6 25 64 68 32
Email	m.e.haveman@umcg.nl

Study information

Primary study design	Observational
Study design	Single-center observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Postoperative continuous telemonitoring; an observational study
Study acronym	TRUST
Study objectives	Telemonitoring may play a role in the early detection of postoperative deterioration, lower workload for nurses and facilitate the migration of care towards home. Wearable biosensors are available for continuous monitoring of vital signs, including temperature, heart rate, respiratory rate, blood oxygenation, and activity parameters. It is still unknown, however, how to incorporate continuous telemonitoring in the perioperative trajectory of surgical patients. The aim of this prospective, observational trial is to assess the feasibility and applicability of telemonitoring by continuous monitoring of vital signs and physical activity of patients at the post-anesthesia care unit (PACU) and a surgical ward.
Ethics approval(s)	Approved 11/11/2021, Ethical Committee University Medical Center Groningen (Hanzeplein 1, Groningen, 9713 GZ, Netherlands; +31 (0)6 55 25 76 00; nwmoloket@umcg.nl), ref: 202000231, METc nr. 2021/440
Health condition(s) or problem(s) studied	Patients admitted to the surgical ward after surgery
Intervention	Patients receive standard care, and in addition will be wearing two wearable sensors for continuous monitoring of heart rate, respiratory rate, temperature and oxygen saturation. No medical decisions will be made using data collected by the wearable sensors in this trial. Patients wear the sensors during their postoperative hospital stay for up to 7 days. 1. The VitalPatch enabling (non-invasive) ECG-based measurements of heart rate (variability), respiration rate, oxygen saturation, body temperature, fall detection and physical activity (step count, and type of activity) at a frequency of once per second. 2. The Masimo Radius PPG sensor enabling (non-invasive) saturation-based measurement of heart rate, respiration rate, body temperature, and oxygen saturation at a frequency of once per minute.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	VitalPatch, Masimo Radius PPG sensor
Primary outcome measure(s)	Feasibility for each sensor during the study period (stay at the surgical ward for a maximum of 7 days) assessed by the following measures: 1. Participation rate: number of patients willing to participate/complete the study protocol 2. Acceptability in terms of satisfaction about the logistics and wearing the sensor, measured by experiences of patients collected using a questionnaire before discharge and at the end of the study 3. Practicality by aspects of (tele)monitoring that involve the actual experience: 3.1. Compliance with the amount of days/hours that the sensor is worn 3.2. Time spent by nurses concerning telemonitoring versus vital parameter measurements in current practice, measured through daily evaluation form and by recording the time needed for intermittent measurements of vital signs manually 3.3. Experiences and recommendations of nurses, assessed with evaluation forms and interviews 3.4. Data quality: missing data, artefacts and reasons for data losses
Key secondary outcome measure(s)	Applicability (for each sensor) during the study period (stay at the surgical ward for a maximum of 7 days): 1. Continuous data stream of vital functions: heart rate, saturation, respiration rate, body temperature, daily step count, type of activity and fall detection 2. Measurements of vital signs in usual care from the electronic medical record 3. Comparison of the characteristics and quality from both wearable sensors will take place for the following outcomes: participation rate, acceptability, practicality, data quality and continuous data stream of vital functions 4. The following clinical and surgical data will be obtained via electronic medical records: age, gender, primary diagnosis, comorbidities, surgery date, procedure type, length of hospital stay, reported early warning scores, incidence and moments of postoperative complication (including falling), treatment, and incidence, moment and duration of unplanned readmission within 30 days after surgery.
Completion date	31/12/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Total final enrolment	124
Key inclusion criteria	1. Patients admitted to the surgical ward 2. Planned for surgery 3. 18 years or older 4. Expected postoperative stay of 48 hours
Key exclusion criteria	1. Mentally incapable of participation 2. Unable to wear wearable devices
Date of first enrolment	01/04/2022
Date of final enrolment	01/07/2023

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from R. van Melzen (r.van.melzen@umcg.nl).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/05/2024: The following changes were made to the trial record:
1. The overall end date was changed from 01/06/2024 to 31/12/2025.
2. The intention to publish date was changed from 01/04/2024 to 01/01/2026.
3. The plain English summary was updated to reflect these changes.
27/10/2023: Study's existence confirmed by the Ethical Committee University Medical Center Groningen.