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Clinical Trials/NCT03102619
NCT03102619
Completed
Not Applicable

Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Bispebjerg Hospital2 sites in 1 country50 target enrollmentMarch 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Cancer
Sponsor
Bispebjerg Hospital
Enrollment
50
Locations
2
Primary Endpoint
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 23, 2017
End Date
July 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Camilla Lundgreen Duus

Research Assistant

Bispebjerg Hospital

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 %

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

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

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

Study Sites (2)

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