Clinical trial NCT03102619: Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
Official title: Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Cancer
Postoperative Complications
Respiratory Complication
Circulatory; Complications
Keywords: Wireless monitoring
Postoperative complications
Vital parameters
Continuous monitoring
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Technical University of Denmark
First posted: 2017-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing major abdominal cancer surgery with a curative intention at either Bispebjerg Hospital or Rigshospitalet.

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.


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

Primary outcomes:
measure: Heart rate resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
measure: Respiration rate resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
measure: Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
measure: Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
timeFrame: The patients are monitored for 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Christian S Meyhoff, MD, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, MD, DMSci
role: STUDY_CHAIR
affiliation: Technical University of Denmark
name: Helge B Dissing, PhD
role: STUDY_CHAIR
affiliation: Bispebjerg Hospital
name: Camilla L Duus, MB
role: PRINCIPAL_INVESTIGATOR
References: