NCT03102619

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

March 24, 2017

Last Update Submit

January 17, 2018

Conditions

Abdominal CancerPostoperative ComplicationsRespiratory ComplicationCirculatory; Complications

Keywords

Wireless monitoringPostoperative complicationsVital parametersContinuous monitoring

Outcome Measures

Primary Outcomes (4)

  • Heart rate resulting in a single parameter score of 3 according to EWS algorithm

    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

    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

    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

    Hypoxemia: arterial oxygen saturation \< 92 %

    The patients are monitored for 4 days

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

  • Camilla L Duus, MB

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 6, 2017

Study Start

March 23, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

DK(2)