Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

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.

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Key information

Conditions

Abdominal Cancer Circulatory; Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Complication

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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
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
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 %

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

Rigshospitalet, Denmark
Technical University of Denmark

Registry information

Acronym: WARD

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Apr 6, 2017
Registry last updated: Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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