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NCT04086056: CraNIRS
CraNIRS Clinical Study
trial testing NIRS monitoring in Craniosynostoses in 40 participants. Completed in 11 October 2023.
11 October 2023
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 20 January 2020 |
| Primary completion | 11 October 2023 |
| Estimated completion | 11 October 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- NIRS monitoring
Conditions studied
- Craniosynostoses — all drugs for Craniosynostoses →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 3 Months to 18 Months, any sex, with Craniosynostoses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems. In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses. In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull. Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.
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 NCT04086056
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NIRS monitoring
Trials testing the same drug.
- NCT04058860 — Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery · NA · completed
- NCT03879330 — NIRS Directed Optimal Cerebral Perfusion Pressure in Aneurysmal Subarachnoid Hemorrhage Patients: A Feasibility Study · unknown
- NCT03814564 — ASSESSment of Perfusion, Oxygen Saturation, Endothelial Function and Coagulation in Circulatory SHOCK · completed
Other recruiting trials for Craniosynostoses
Currently open trials in the same condition.
- NCT06533150 — Functionalized Bioink Delivering Biomolecules for the Treatment of Craniofacial Diseases · active not recruiting
- NCT04159675 — Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts · recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
- NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
- NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
- NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting
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 NCT04086056 (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 Hospices Civils de Lyon
- Last refreshed: 21 February 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/NCT04086056.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing