Continuous remote monitoring to detect critical early warning scores in patients after abdominal surgery
| ISRCTN | ISRCTN17454502 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17454502 |
| Secondary identifying numbers | 2015.496 |
- Submission date
- 07/05/2019
- Registration date
- 01/10/2019
- Last edited
- 07/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
To evaluate patients in the postoperative period following abdominal surgery, especially the incidence of hypoxemia (low level of oxygen in the blood), changes in respiratory rate and incidence of critical early warning scores.
Who can participate?
Adult patients who underwent major abdominal surgery with an increased preoperative risk for postoperative pulmonary complications can participate in the study
What does the study involve?
Heart rate, respiratory rate, pulse oximetry data collected from the remote monitoring device. Available heart rate, blood pressure, respiratory rate, temperature, pulse oximetry data measured by the nurses will be retrieved from hospital records. Patient vital parameters, heart rate, pulse oximetry, the respiratory rate will be monitored by a remote wireless monitor, worn on an arm, the size of a small i-pod, that is connected to an adhesive sensor in the patients’ neck and a probe on the index finger. Data is collected through WiFi or Bluetooth to a distant monitor
What are the possible benefits and risks of participating?
If an acute detoriation might occur the remote monitoring data will be made available for the medical team to support medical decision making.
There are no negative effects for patients volunteering in the study.
Where is the study run from?
VU University Medical Center Amsterdam, Netherlands
When is the study starting and how long is it expected to run for?
February 2016 to December 2016
Who is funding the study?
VU University Medical Center Amsterdam, Netherlands
Who is the main contact?
Mr Hugo Touw,
hugo.touw@radboudumc.nl
Contact information
Public
Jozef Israelsstraat 85
Nijmegen
6523 CH
Netherlands
 ORCID ID |
0000-0001-5970-0157 |
|---|---|
| Phone | 0655154508 |
| hugo.touw@radboudumc.nl |
Study information
| Study design | Prospective explorative observational feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Continuous remote monitoring to detect critical early warning scores in patients after abdominal surgery: a prospective observational study |
| Study acronym | PulMONIC |
| Study objectives | Critical modified early warning score (MEWS) is detected with continuously remote monitoring of vital signs in patients after abdominal surgery. |
| Ethics approval(s) | Approved 06/01/2016, Human Subjects Committee of VUmc (Medisch Ethische Toetsingscommissie VU medisch centrum, voorzitter: prof. dr. JA Rauwerda, intern postadres: BS7, kamer H-565; 020-44 45585; metc@vumc.nl) |
| Health condition(s) or problem(s) studied | Postoperative care |
| Intervention | Patients are asked to wear the remote monitoring device for clinical evaluation for the first 3 days after the operation. During the pilot, no alarms will be set on the device. Treatment and monitoring will be according to daily practice. Volunteering in the pilot study will not influence their treatment. There will be a short questionnaire (5 min) after 3 days of wearing the remote monitor. Patients can decide to discontinue wearing the monitor at all times. Heart rate, respiratory rate, pulse oximetry data collected from the remote monitoring device. Available heart rate, blood pressure, respiratory rate, temperature, pulse oximetry data measured by the nurses will be retrieved from hospital records. Patient vital parameters, heart rate, pulse oximetry, the respiratory rate will be monitored by a remote wireless monitor, worn on an arm, the size of a small i-pod, that is connected to an adhesive sensor in the patients’ neck and a probe on the index finger. Data is collected through WiFi or Bluetooth to a distant monitor. Patient records are checked for postoperative complications in 30 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Critical early warning scores measured by continuous remote monitoring of the respiratory rate, SpO2 and pulse rate in four postoperative days. |
| Secondary outcome measures | Postoperative pulmonary complications retrospectively scored using patient records. |
| Overall study start date | 01/05/2015 |
| Completion date | 31/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Adult patients who underwent major abdominal surgery with an increased preoperative risk for postoperative pulmonary complications |
| Key exclusion criteria | 1. Withdrawal of informed consent 2. Cancelled surgery 3. Total monitoring time < 8 hours |
| Date of first enrolment | 01/02/2016 |
| Date of final enrolment | 27/12/2016 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1081 HV
Netherlands
Sponsor information
University/education
Boelelaan 1115
Amsterdam
1081 HV
Netherlands
| Phone | +31204444444 |
|---|---|
| h.touw@vumc.nl | |
| Website | www.vumc.nl |
"ROR" |
https://ror.org/008xxew50 |
Funders
Funder type
Not defined
Private sector organisation / Universities (academic only)
- Alternative name(s)
- VU University Amsterdam, VU University, VU
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/07/2019 |
|---|---|
| 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. 2019 results in thesis https://research.vu.nl/ws/portalfiles/portal/82342764/cover.pdf |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2021 | 07/09/2021 | Yes | No | |
| Thesis results | 04/07/2019 | 07/09/2021 | No | No |
Editorial Notes
07/09/2021: Publication reference added.
06/11/2019: Thesis added to publication and dissemination plan.
28/05/2019: Trial’s existence confirmed by Vrije Universiteit Amsterdam (VUmc).
