Effect of wearable continuous vital signs measurements on general wards length of stay
| ISRCTN | ISRCTN37125996 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37125996 |
| Secondary identifying numbers | ID1 |
- Submission date
- 13/12/2021
- Registration date
- 24/12/2021
- Last edited
- 19/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Surgical complications are unfortunately still common. For several years now, wearable, wireless devices for continuous measurements of vital signs become available instead of intermittent, manual measurements. This makes it possible to detect clinical deterioration earlier, potentially improving care outcomes. The study aims to determine the effect of continuous monitoring of vital signs in the ward on length of hospital stay in colorectal, pancreatic, and liver surgery.
Who can participate?
Patients undergoing colorectal, pancreatic, or liver resections.
What does the study involve?
Patients wear a wearable sensor for continuously measuring heart rate and respiratory rate after surgery during their hospital stay.
What are the possible benefits and risks of participating?
Possible benefit for patients is that clinical deterioration is earlier detected and treated. There are no risks in participating.
Where is the study run from?
Isala, Zwolle (Netherlands)
When is the study starting and how long is it expected to run for?
February 2020 to July 2022
Who is funding the study?
Isala Innovation & Science Funds (Netherlands)
Who is the main contact?
JPL Leenen, MSc, j.p.l.leenen@isala.nl
Contact information
Scientific
Dr. van Heesweg 2
Zwolle
8025 AB
Netherlands
 ORCID ID |
0000-0001-7269-2892 |
|---|---|
| Phone | +31 384241245 |
| j.p.l.leenen@isala.nl |
Scientific
Dr. van Heesweg 2
Zwolle
8025 AB
Netherlands
| ORCID ID |
0000-0001-8113-4171 |
|---|---|
| Phone | +31 384244349 |
| g.a.patijn@isala.nl |
Study information
| Study design | Prospective single-arm study with historic control group |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40808 PIS v1 01April2021.pdf |
| Scientific title | Effectiveness of wireless wearable continuous vital signs monitoring on wards: a prospective single-arm study with historical control group |
| Study acronym | Ef-CoMoViSi trial |
| Study objectives | Continuous monitoring of vital signs reduces length of stay than intermittent vital signs monitoring on the general ward |
| Ethics approval(s) |
Approved 17/12/2021, METC Isala (Dr. van Heesweg 2, Building M [Mondriaan], room 0.25, Mailbox 10400, Zwolle, 8000 GK, Netherlands; +31 (0)88 624 30 82; metc@isala.nl), ref: 20211114 |
| Health condition(s) or problem(s) studied | Vital signs of surgical patients undergoing colorectal, liver and pancreatic resections |
| Intervention | During the pre-admission consult by telephone, study information is given by the nurse and informed consent was provided by the patient. When patients are admitted and underwent surgery, the wearable sensor (Philips Healthdot) for continuous monitoring of vital signs is attached by the nurse. Vital signs are intermittently measured and monitored according to the Modified Early Warning Score protocol (once daily). Until discharge, the patient wears the sensor and vital sign trends are reviewed six times a day by the nurse and once a day by the physician. When trends deviated, necessary actions were taken. When the patient was discharged, the sensor was detached. After one month, clinical outcomes were registered based upon the patient file. The control group was a historical cohort of patients included through the EMR. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Wearable vital signs monitoring (Philips Healthdot, Philips, Eindhoven, NL) |
| Primary outcome measure | Length of stay (in days) measured using the admission and discharge date in days from the Electronic Medical Record (EMR) at 30 days after discharge. |
| Secondary outcome measures | 1. RRT calls measured using reports in the EMR at 30 days after discharge. 2. House-officer calls measured using reports in the EMR at 30 days after discharge 3. Unplanned ICU admission measured using reports in the EMR at 30 days after discharge 4. ICU length of stay measured using reports in the EMR at 30 days after discharge 5. Mortality measured using reports in the EMR at 30 days after discharge 6. Readmission measured using reports in the EMR at 30 days after discharge 7. Unplanned diagnostics measured using reports in the EMR at 30 days after discharge 8. Discharge destination measured using reports in the EMR at 30 days after discharge 9. Nursing care after admission measured using reports in the EMR at 30 days after discharge 10. Days alive at home (DAH30) measured using reports in the EMR at 30 days after discharge 11. Complication rate according Clavien-Dindo classification using reports in the EMR at 30 days after discharge 12. Failure-to-rescue measured using reports in the EMR at 30 days after discharge |
| Overall study start date | 01/02/2020 |
| Completion date | 01/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1027 |
| Key inclusion criteria | 1. Expected length of stay ≥2 days 2. Admitted to the surgical ward of Isala 3. Admission indication: Colorectal, Liver or Pancreatic resection |
| Key exclusion criteria | Not being able to provide informed consent |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 01/07/2022 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Zwolle
8025 AB
Netherlands
Sponsor information
Hospital/treatment centre
Dr. van Heesweg 2
Zwolle
8025 AB
Netherlands
| Phone | +31 384244349 |
|---|---|
| g.a.patijn@isala.nl | |
| Website | http://isala.nl |
"ROR" |
https://ror.org/046a2wj10 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The anonymized datasets generated during and analysed during the current study will be available upon request from JPL Leenen (j.p.l.leenen@isala.nl) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 01/04/2021 | 21/12/2021 | No | Yes |
| Results article | 17/01/2024 | 19/01/2024 | Yes | No |
Additional files
Editorial Notes
19/01/2024: Publication reference added.
07/11/2023: The intention to publish date was changed from 01/09/2023 to 01/12/2023.
21/12/2021: Trial's existence confirmed by METC Isala.
