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,
hugo.touw@radboudumc.nl
Trial website
Contact information
Type
Public
Primary contact
Mr Hugo Touw
ORCID ID
http://orcid.org/0000-0001-5970-0157
Contact details
Jozef Israelsstraat 85
Nijmegen
6523 CH
Netherlands
0655154508
hugo.touw@radboudumc.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2015.496
Study information
Scientific title
Continuous remote monitoring to detect critical early warning scores in patients after abdominal surgery: a prospective observational study
Acronym
PulMONIC
Study hypothesis
Critical modified early warning score (MEWS) is detected with continuously remote monitoring of vital signs in patients after abdominal surgery.
Ethics approval
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)
Study design
Prospective explorative observational feasibility study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
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
Phase
Drug names
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
01/05/2015
Overall trial end date
31/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients who underwent major abdominal surgery with an increased preoperative risk for postoperative pulmonary complications
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Withdrawal of informed consent
2. Cancelled surgery
3. Total monitoring time < 8 hours
Recruitment start date
01/02/2016
Recruitment end date
27/12/2016
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center Amsterdam
Boelelaan 1115
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Vrije Universiteit Amsterdam (VUmc)
Sponsor details
Boelelaan 1115
Amsterdam
1081 HV
Netherlands
+31204444444
h.touw@vumc.nl
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Vrije Universiteit Amsterdam
Alternative name(s)
VU University Amsterdam, VU University, VU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
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
01/07/2019
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).
Publication list