Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study (WARD)

January 17, 2018 updated by: Camilla Lundgreen Duus, Bispebjerg Hospital

Postoperative observation of patients is based on the Early Warning Score (EWS). By using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. The object of this pilot study is to test the equipment and methods for the next phases. Patients will be monitored for 4 days postoperatively and data is analyzed retrospectively. Vital parameters are monitored with ECG, blood pressure monitor and pulseoximetry.

In the analysis the investigators will compare the results from the continuous monitoring to the measurements made by the nurses and registered in the EWS. The primary outcomes for the pilot study are the frequency of measurements resulting in a single parameter score of 3 according to the EWS algorithm.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing major abdominal cancer surgery with a curative intention at either Bispebjerg Hospital or Rigshospitalet.

Description

Inclusion Criteria:

  • Diagnosis of cancer of either esophagus, stomach, pancreas, liver, colon or rectum.
  • Elective surgery with curative intention at Bispebjerg Hospital or Rigshospitalet in Copenhagen, Denmark.
  • Estimated duration of surgery > 2 hours
  • > 65 years
  • Preoperative ECG showing sinus rhythm
  • No treatment limitations
  • Fit to receive optimized care according to the regimens on the given wards

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate resulting in a single parameter score of 3 according to EWS algorithm
Time Frame: The patients are monitored for 4 days

All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used:

Bradycardia: pulse < 41 bpm Tachycardia: pulse > 130 bpm
The patients are monitored for 4 days
Respiration rate resulting in a single parameter score of 3 according to EWS algorithm
Time Frame: The patients are monitored for 4 days
Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min
The patients are monitored for 4 days
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
Time Frame: The patients are monitored for 4 days
Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg
The patients are monitored for 4 days
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
Time Frame: The patients are monitored for 4 days
Hypoxemia: arterial oxygen saturation < 92 %
The patients are monitored for 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Rigshospitalet, Denmark
Technical University of Denmark

Investigators

  • Study Chair: Christian S Meyhoff, MD, PhD, Bispebjerg Hospital
  • Study Chair: Eske K Aasvang, MD, DMSci, Rigshospitalet, Denmark
  • Study Chair: Helge B Dissing, PhD, Technical University of Denmark
  • Principal Investigator: Camilla L Duus, MB, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bispebjerg Hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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