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NCT03150953
Evaluation of a Novel Patient Warming System During MRI
NA trial testing MRI-safe bore covering in Anesthesia; Hypothermia in 60 participants. Completed in 30 November 2018.
1 May 2018
Quick facts
| Lead sponsor | Andrew Matisoff |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 26 May 2016 |
| Primary completion | 1 May 2018 |
| Estimated completion | 30 November 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MRI-safe bore covering
Conditions studied
- Anesthesia; Hypothermia — all drugs for Anesthesia; Hypothermia →
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
Sponsor
Andrew Matisoff
Who can join
Under 7, any sex, with Anesthesia; Hypothermia or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. Cardiac MRI scans performed for patients who require general anesthesia can cause a loss of body heat. Several mechanisms exist for reducing hypothermia under anesthesia including forced air warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no MRI-compatible systems which allow patient warming and prevention of hypothermia in anesthetized patient in the MRI-scanner. This study is testing a non-invasive device that warms patients under clinically indicated general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI scanner.
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 NCT03150953
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Related trials
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 NCT03150953 (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 Andrew Matisoff
- Last refreshed: 28 March 2019
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/NCT03150953.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing