Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03102619

Acronym

WARD

Enrollment

Registered

2017-04-06

Start date

2017-03-23

Completion date

2017-07-01

Last updated

2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Wireless monitoring, Postoperative complications, Vital parameters, Continuous monitoring

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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 %

Countries

Denmark

Outcome results