NCT03102619|Completed
Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
WARD
Loading search results
WARD
Sponsor study identifier
observational
50
1 country
2
Study Start
March 23, 2017
Actual (reported)Primary Completion
July 1, 2017
Actual (reported)Study Completion
July 1, 2017
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2017
Actual (reported)March 24, 2017
Actual (reported)April 6, 2017
Actual (reported)July 1, 2017
Actual (reported)July 1, 2017
Actual (reported)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
Patients undergoing major abdominal cancer surgery with a curative intention at either Bispebjerg Hospital or Rigshospitalet.
Rigshospitalet
Copenhagen, 2100, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Christian S Meyhoff, MD, PhD
Bispebjerg Hospital
Eske K Aasvang, MD, DMSci
Copenhagen University Hospital, Rigshospitalet
Helge B Dissing, PhD
Technical University of Denmark
Camilla L Duus, MB
Bispebjerg Hospital
50 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2017
First Posted
April 6, 2017
Study Start
March 23, 2017
Actual (reported)High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy
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
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2017
Actual (reported)Study Completion
July 1, 2017
Actual (reported)Last Updated
January 18, 2018
Record last verified: 2018-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: