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NCT03330379: CONTIPRESS
Comparison of Two Strategies for Endotracheal Tube Cuff Underinflation Prevention During Invasive Mechanical Ventilation
NA trial testing Tracoe Smart CuffmanagerTM in Acute Brain Injury in 60 participants. Completed in 31 July 2019.
31 July 2019
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 60 |
| Start date | 1 March 2018 |
| Primary completion | 31 July 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- Tracoe Smart CuffmanagerTM
Conditions studied
- Acute Brain Injury — all drugs for Acute Brain Injury →
- Brain Injuries — all drugs for Brain Injuries →
Sponsor
Nantes University Hospital
Who can join
18 and older, any sex, with Acute Brain Injury or Brain Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study.
Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, et al · · 2020 · cited 13× · PMID 32376293 · DOI 10.1016/j.accpm.2020.04.007
Verify or expand the search:
- PubMed search for NCT03330379
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Nantes University Hospital trials
Trials by the same sponsor.
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- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
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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 NCT03330379 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 4 September 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/NCT03330379.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing