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NCT03861026
Cerebral Oximetry to Reduce Organ Dysfunction After Non-cardiac Surgery
NA trial testing Bilateral NIRS (Masimo, O3TM Regional Oximetry) in Cerebral Desaturation in 101 participants. Completed in 30 June 2023.
30 January 2023
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 101 |
| Start date | 5 October 2018 |
| Primary completion | 30 January 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Bilateral NIRS (Masimo, O3TM Regional Oximetry)
Conditions studied
- Cerebral Desaturation — all drugs for Cerebral Desaturation →
- Surgery — all drugs for Surgery →
Sponsor
University Health Network, Toronto
Who can join
60 and older, any sex, with Cerebral Desaturation or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. A decrease in brain oxygen is a sign that all other vital organs such as kidneys, heart, liver, and intestines have reduced blood supply and are starved from oxygen. This happens in 1 out of 5 patients undergoing major complex surgeries. Brain oxygen saturation monitor at this time is not used routinely during surgery, primarily due to the added cost, as well as, insufficient evidence that restoring the brain oxygen saturation to baseline would result in better outcomes. Patients will be randomly assigned to either study or control groups. In the study group, a special algorithm will be used to restore brain oxygen saturation. In the control group, the brain oxygen saturation will be monitored continuously, but the monitor screen will be electronically blinded, and standard clinical care applied. The objective of this study is to see if restoring the brain oxygen saturation to baseline results in less complication rates after surgery. The objective of this study is to reduce the incidence of postoperative morbidity due to end organ dysfunction after major non-cardiac surgery in elderly patients. The primary aim is to determine if restoration of rSO2 to baseline levels results in reduced incidence of major organ morbidity and mortality (MOMM). A secondary aim is to determine a cost-effectiveness of this monitoring modality.
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 NCT03861026
- Europe PMC full search
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Related trials
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Currently open trials in the same condition.
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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 NCT03861026 (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 University Health Network, Toronto
- Last refreshed: 11 December 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/NCT03861026.
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