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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03102619
Other study ID # Bispebjerg Hospital
Secondary ID
Status Completed
Phase N/A
First received March 24, 2017
Last updated January 17, 2018
Start date March 23, 2017
Est. completion date July 1, 2017

Study information

Verified date January 2018
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen
Denmark Rigshospitalet Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
Bispebjerg Hospital Rigshospitalet, Denmark, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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