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Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study (WARD)

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ClinicalTrials.gov Identifier: NCT03102619
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Technical University of Denmark
Information provided by (Responsible Party):
Camilla Lundgreen Duus, Bispebjerg Hospital

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.


Condition or disease
Abdominal Cancer Postoperative Complications Respiratory Complication Circulatory; Complications

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017



Primary Outcome Measures :
  1. 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


  2. 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

  3. 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

  4. 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 %



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing major abdominal cancer surgery with a curative intention at either Bispebjerg Hospital or Rigshospitalet.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102619


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Rigshospitalet, Denmark
Technical University of Denmark
Investigators
Study Chair: Christian S Meyhoff, MD, PhD Bispebjerg Hospital
Study Chair: Eske K Aasvang, MD, DMSci Rigshospitalet, Denmark
Study Chair: Helge B Dissing, PhD Technical University of Denmark
Principal Investigator: Camilla L Duus, MB Bispebjerg Hospital

Responsible Party: Camilla Lundgreen Duus, Research Assistant, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03102619     History of Changes
Other Study ID Numbers: Bispebjerg Hospital
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Camilla Lundgreen Duus, Bispebjerg Hospital:
Wireless monitoring
Postoperative complications
Vital parameters
Continuous monitoring

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes