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NCT03479047: CODEX
Diaphragmatic Ultrasound Associated With RSBI Predict Weaning Issue: the Rapid Shallow Diaphragmatic Index (RSDI)
NA trial testing assess diaphragmatic displacement (DD) using ultrasonography in Mechanical Ventilation in 100 participants. Completed in 16 January 2019.
16 January 2019
Quick facts
| Lead sponsor | Centre Hospitalier Régional d'Orléans |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 100 |
| Start date | 23 March 2018 |
| Primary completion | 16 January 2019 |
| Estimated completion | 16 January 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- assess diaphragmatic displacement (DD) using ultrasonography
Conditions studied
- Mechanical Ventilation — all drugs for Mechanical Ventilation →
- Mechanical Ventilator Weaning — all drugs for Mechanical Ventilator Weaning →
- Extubation — all drugs for Extubation →
- Diaphragm Ultrasound — all drugs for Diaphragm Ultrasound →
Sponsor
Centre Hospitalier Régional d'Orléans
Who can join
18 and older, any sex, with Mechanical Ventilation or Mechanical Ventilator Weaning. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Rapid Shallow Breathing Index (RSBI) is the ratio between respiratory rate (RR) and tidal volume (VT). It is routinely used to predict mechanical ventilation weaning outcome in ICU patients. However RSBI doesn't reflect the muscular contribution of diaphragm or accessory muscles in generating tidal volume. Actually, diaphragmatic dysfunction can even delay weaning process, because accessory muscles are more fatigable than the diaphragm. Hence, the investigators hypothesized that diaphragmatic displacement (DD) could be associated with RSBI in a new index named Rapid Shallow Diaphragmatic Index (RSDI) such as: RSDI = RSBI/DD. The aim of this study is to compare the ability of the RSDI versus the traditional RSBI to predict weaning success in ready-to-wean patients.
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 NCT03479047
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Centre Hospitalier Régional d'Orléans 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 NCT03479047 (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 Centre Hospitalier Régional d'Orléans
- Last refreshed: 6 May 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/NCT03479047.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing