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NCT06637540: RD_CPB
Clinical Validation of a Novel Handsfree Doppler Ultrasound Device, RescueDoppler, in Adult Cardiac Surgery Patients
NA trial testing RescueDoppler in Cardio-pulmonary Bypass in 42 participants. Completed in 1 November 2024.
1 November 2024
Quick facts
| Lead sponsor | St. Olavs Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 42 |
| Start date | 28 January 2024 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2024 |
| Sites | 3 locations across Norway |
Drugs / interventions tested
- RescueDoppler
- RescueDoppler
Conditions studied
- Cardio-pulmonary Bypass — all drugs for Cardio-pulmonary Bypass →
- AORTIC VALVE DISEASES — all drugs for AORTIC VALVE DISEASES →
- Coronary Arterial Disease (CAD) — all drugs for Coronary Arterial Disease (CAD) →
- Aortic Aneurysm of the Proximal Arch — all drugs for Aortic Aneurysm of the Proximal Arch →
Sponsor
St. Olavs Hospital
Who can join
Adults 18 to 80, any sex, with Cardio-pulmonary Bypass or AORTIC VALVE DISEASES. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this study is to evaluate a new device called RescueDoppler (RD), which measures continuous blood flow in the common carotid artery. The device is handsfree and operator- independent. The research will involve adult participants who are undergoing cardiac surgery at St. Olavs Hospital in Trondheim, Norway. The aim of the first part of the study is to evaluate the RescueDoppler system in comparison to conventional Doppler ultrasound, which is commonly used to assess blood flow in carotid artery. The researchers will measure blood flow in the left common carotid artery in three different reversible situations: * when the participant is resting, * when there is increased blood flow (passive leg raise) and * when there is decreased blood flow ( breathing against a resistance). We will initially conduct the investigation using the conventional Doppler. Subsequently, we will repeat the interventions with the RD patch positioned over the left common carotid artery. The RD patch will stay positioned over the left carotid artery after the completion of the comparison phase. In the subsequent phase, the focus will shift to transitions between normal blood flow and low or absent blood flow and the RescueDopplers ability to detect. During cardiac surgery, participants will experience fluctuations in blood pressure, pulse, and circulation. By measuring blood flow with the RescueDoppler during these variations, researchers will evaluate the device´s capability to monitor different blood flow patterns. Overall, the study aims to provide valuable insights into the effectiveness of the RescueDoppler in a clinical setting where changes in blood flow are expected.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06637540
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RescueDoppler
Trials testing the same drug.
- NCT06599073 — RescueDoppler- a Disruptive Ultrasound Solution for Improved Outcome After Cardiac Arrest. · NA · completed
Other St. Olavs Hospital trials
Trials by the same sponsor.
- NCT07331766 — Collaboratory Treatment Pathway for Chronic Pain Patients. · NA · enrolling by invitation
- NCT07305025 — Pelvic Pain Electro-Acupuncture · NA · not yet recruiting
- NCT07245264 — Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH) · Phase 2, PHASE3 · recruiting
- NCT07180433 — Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer · NA · not yet recruiting
- NCT06854861 — Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes · Phase 1, PHASE2 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06637540 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Olavs Hospital
- Last refreshed: 4 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06637540.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing