Plain English Summary
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,
Continuous remote monitoring to detect critical early warning scores in patients after abdominal surgery: a prospective observational study
Critical modified early warning score (MEWS) is detected with continuously remote monitoring of vital signs in patients after abdominal surgery.
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; firstname.lastname@example.org)
Prospective explorative observational feasibility study
Primary study design
Secondary study design
Patient information sheet
No participant information sheet available
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.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Adult patients who underwent major abdominal surgery with an increased preoperative risk for postoperative pulmonary complications
Target number of participants
Participant exclusion criteria
1. Withdrawal of informed consent
2. Cancelled surgery
3. Total monitoring time < 8 hours
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
VU University Medical Center Amsterdam
Vrije Universiteit Amsterdam
VU University Amsterdam, VU University, VU
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Continuous remote monitoring was feasible in 97 out of 100 eligible patients (97%, 95% CI: 91 to 99%). Thirty-nine patients (40%, 95% CI: 30 to 51%) developed one or more postoperative pulmonary complications.
Critical remote MEWS was detected in 11.6% (0.8-20.8) of the monitoring time in patients with a postoperative pulmonary complication compared to 0.44% (0.1-2.7) in patients without a postoperative pulmonary complication (P<0.001).