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NCT06597214
Intraoperative Warming: Comparison of Two Temperature Management Systems
NA trial testing AVACore Technologies, Inc. warmUP Sleeve in Normothermia in 90 participants. Completed in 15 May 2025.
15 May 2025
Quick facts
| Lead sponsor | Tampa General Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 June 2023 |
| Primary completion | 15 May 2025 |
| Estimated completion | 15 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- AVACore Technologies, Inc. warmUP Sleeve
- Arizant Healthcare Bair Hugger®
Conditions studied
- Normothermia — all drugs for Normothermia →
- Intraoperative Temperature — all drugs for Intraoperative Temperature →
- Anesthesia — all drugs for Anesthesia →
Sponsor
Tampa General Hospital
Who can join
Adults 18 to 80, any sex, with Normothermia or Intraoperative Temperature. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to compare two temperature management systems, the warmUP (WU-20) and the Bair Hugger®, in preventing perioperative hypothermia during surgeries. The study aims to determine whether the warmUP system is as effective as the Bair Hugger® in maintaining core body temperature. The main questions this trial aims to answer are: Does the warmUP system maintain intraoperative body temperatures as effectively as the Bair Hugger® during abdominal surgeries? Does the warmUP system offer additional benefits, such as reduced bacterial dispersion compared to the Bair Hugger®? Participants will: Use either the warmUP or Bair Hugger® system during surgery Undergo abdominal surgeries lasting approximately 2.5 hours Have their core temperatures monitored to assess the effectiveness of the warming device The study will evaluate whether the warmUP system provides equivalent temperature management with a smaller body surface area exposed, potentially offering advantages in surgical infection control.
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 NCT06597214
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other Tampa General Hospital trials
Trials by the same sponsor.
- NCT04217343 — NCAMR-CAMR Allosure Study · unknown
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 NCT06597214 (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 Tampa General Hospital
- Last refreshed: 25 June 2025
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/NCT06597214.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing