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NCT03889847
Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.
NA trial testing Fibreoptic intubation with silicone double lumen tube in Intubation;Difficult in 46 participants. Completed in 20 December 2019.
19 December 2019
Quick facts
| Lead sponsor | Ajou University School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 46 |
| Start date | 25 April 2019 |
| Primary completion | 19 December 2019 |
| Estimated completion | 20 December 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Fibreoptic intubation with silicone double lumen tube
- Fibreoptic intubation with PVC double lumen tube
Conditions studied
- Intubation;Difficult — all drugs for Intubation;Difficult →
Sponsor
Ajou University School of Medicine
Who can join
Adults 19 to 75, any sex, with Intubation;Difficult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB easier than the Shilly tube. In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparison of fiberoptic bronchoscopic intubation using silicone and polyvinyl chloride double-lumen tubes.
Kang S, Chae YJ, Kim DH, Kim TG, et al · · 2023 · cited 4× · PMID 36577506 · DOI 10.4097/kja.22649
Verify or expand the search:
- PubMed search for NCT03889847
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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 NCT03889847 (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 Ajou University School of Medicine
- Last refreshed: 20 January 2021
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/NCT03889847.
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