Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Completed

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

• Registration Number: NCT03102619
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-06
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm	The patients are monitored for 4 days	Hypoxemia: arterial oxygen saturation \< 92 %
Heart rate resulting in a single parameter score of 3 according to EWS algorithm	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
Respiration rate resulting in a single parameter score of 3 according to EWS algorithm	The patients are monitored for 4 days	Bradypnea: \< 9 breaths/min Tachypnea: \> 24 breaths/min
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm	The patients are monitored for 4 days	Hypotension: Systolic blood pressure \< 91 mmHg Hypertension: Systolic blood pressure \> 219 mmHg

Trial Locations

Locations (2)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark