Clinical trial · Observational
Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
| Circulatory; Complications | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Respiratory Complication | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Heart rate resulting in a single parameter score of 3 according to EWS algorithm
- timeFrame
- The patients are monitored for 4 days
- description
- 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
- measure
- Respiration rate resulting in a single parameter score of 3 according to EWS algorithm
- timeFrame
- The patients are monitored for 4 days
- description
- Bradypnea: \< 9 breaths/min Tachypnea: \> 24 breaths/min
- measure
- Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
- timeFrame
- The patients are monitored for 4 days
- description
- Hypotension: Systolic blood pressure \< 91 mmHg Hypertension: Systolic blood pressure \> 219 mmHg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available