Monitoring blood pressure continuously during non-cardiac surgery
Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial
This study is testing if using continuous blood pressure monitoring during non-cardiac surgeries can help keep patients' blood pressure stable better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 930 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06753097 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of continuous finger-cuff arterial pressure monitoring compared to traditional intermittent oscillometric monitoring in reducing intraoperative hypotension during elective non-cardiac surgeries. It focuses on low-to-moderate risk patients undergoing procedures that require general anesthesia. The study aims to determine if continuous monitoring can lead to better management of blood pressure throughout the surgical process, potentially improving patient outcomes. Participants will be randomly assigned to one of the two monitoring methods during their surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older scheduled for elective non-cardiac surgery lasting at least 30 minutes, particularly those classified as low to moderate risk.
Not a fit: Patients undergoing emergency surgery or those with contraindications for finger-cuff monitoring will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood pressure management and reduced complications during non-cardiac surgeries.
How similar studies have performed: While continuous monitoring techniques have been explored in other contexts, this specific approach is novel and has not been extensively tested in the setting of non-cardiac surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
We will include three types of patients: 1. Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes 2. Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes 3. Moderate-risk patients (ASA III) having inpatient elective non-cardiac surgery expected to last ≥60 minutes We will only include patients who are 18 years or older; who will have general anesthesia; and in whom intermittent arterial pressure monitoring with upper-arm cuff oscillometry is planned. Patients that meet one or more of the following exclusion criteria cannot participate in the trial: * Emergency surgery * Patients on renal replacement therapy * Contraindications for finger-cuff monitoring (e.g., Raynaud disease)
Where this trial is running
Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Bernd Saugel, MD
- Email: b.saugel@uke.de
- Phone: +49741052415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.