Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Postoperative Complications Clinical Trial

— WARD  

Official title:

Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102619
• Other study ID #: Bispebjerg Hospital
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Cancer
• Circulatory; Complications
• Postoperative Complications
• Respiratory Complication

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