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NCT03768154: PROSE
Prone Positioning and Spontaneous Breathing
Phase 1 trial testing Supine + spontaneous effort in Critical Illness in 12 participants. Status unknown.
8 May 2020
Quick facts
| Lead sponsor | Osaka University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 March 2019 |
| Primary completion | 8 May 2020 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Supine + spontaneous effort
- Supine + paralysis
- Prone + paralysis
- Prone + spontaneous breathing
Conditions studied
- Critical Illness — all drugs for Critical Illness →
- ARDS — all drugs for ARDS →
Sponsor
Osaka University
Who can join
18 and older, any sex, with Critical Illness or ARDS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Spontaneous breathing during mechanical ventilation has been recommended in patients with ARDS and is currently used. in part because oxygenation is better and there is a lower risk of diaphragm dysfunction due to disuse. The other approach to minimizing lung injury from spontaneous effort is the use of neuromuscular blockade; an early and short term (48 hours) of neuromuscular blockade in patients with severe ARDS has been shown to decrease inflammation and to improve survival. The investigators propose a pilot study to test the feasibility and the physiological effects of allowing spontaneous breathing in the prone position in patients with ARDS.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03768154
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Osaka University trials
Trials by the same sponsor.
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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 NCT03768154 (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 Osaka University
- Last refreshed: 15 May 2020
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/NCT03768154.
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