Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

NCT ID: NCT03102619

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-23

Study Completion Date

2017-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Cancer Postoperative Complications Respiratory Complication Circulatory; Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Technical University of Denmark

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Camilla Lundgreen Duus

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian S Meyhoff, MD, PhD

Role: STUDY_CHAIR

Bispebjerg Hospital

Eske K Aasvang, MD, DMSci

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Helge B Dissing, PhD

Role: STUDY_CHAIR

Technical University of Denmark

Camilla L Duus, MB

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Bispebjerg Hospital

Identifier Type: -

Identifier Source: org_study_id

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