Condition category
Surgery
Date applied
07/05/2019
Date assigned
01/10/2019
Last edited
01/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.vumc.nl

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

Publication citations

Additional files

Editorial Notes

28/05/2019: Trial’s existence confirmed by Vrije Universiteit Amsterdam (VUmc).