Detecting tissue blood flow issues using a CO2 sensor during flap surgery
Detecting Tissue Ischemia in Reconstruction Flaps by a Novel CO2 Biosensor (DIMENSION-study); An Open, Prospective, Intervention Study
NA · Oslo University Hospital · NCT05487820
This study is testing a new device that tracks carbon dioxide levels in tissue after flap surgery to see if it can help doctors quickly spot and fix blood flow problems in patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05487820 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the feasibility and safety of the IscAlert™ device, which continuously monitors carbon dioxide levels in tissue following reconstructive flap surgery. The device is inserted into normal muscle or subcutaneous tissue to detect signs of ischemia, indicated by increased CO2 levels and decreased local temperature. If ischemia is detected, the surgical team can intervene promptly to assess and potentially correct the blood flow issue. A total of 56 patients will be enrolled, and the monitoring will continue for up to 10 days post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for reconstructive flap surgery.
Not a fit: Patients who are involved in other conflicting studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could significantly improve the early detection of ischemia in reconstructive surgeries, potentially reducing complications and improving patient outcomes.
How similar studies have performed: Previous studies using similar biosensing techniques have shown promising results in detecting ischemia, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be scheduled for reconstructive flap surgery * surgery * Patients must be ≥ 18 years * Patients must be able to give written signed informed consent Exclusion Criteria: • Another study interfering with current study
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Magne Røkkum, MD, Ph.D — Oslo University Hospital
- Study coordinator: Magne Røkkum, MD, Ph.D
- Email: magne.rokkum@medisin.uio.no
- Phone: 90839385
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.
Conditions: Ischemia, Blood Circulation Disorder, Biosensing Techniques, Surgery, Biosensor, Reconstructive, Carbon dioxide, Flap