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NCT03109678
A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
NA trial testing Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™ in Airway Management in 80 participants. Completed in 7 March 2012.
7 March 2012
Quick facts
| Lead sponsor | Asklepios Kliniken Hamburg GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 80 |
| Start date | 12 July 2011 |
| Primary completion | 7 March 2012 |
| Estimated completion | 7 March 2012 |
Drugs / interventions tested
- Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™
- Crossover Ambu Aura-i™ / LMA ETT™
- Crossover FASTRACH™ / Rüsch Super Safety Silk™
- Crossover FASTRACH™ / LMA ETT™
Conditions studied
- Airway Management — all drugs for Airway Management →
- Laryngeal Mask Airway — all drugs for Laryngeal Mask Airway →
- Fibreoptic Intubation — all drugs for Fibreoptic Intubation →
Sponsor
Asklepios Kliniken Hamburg GmbH — full company profile →
Who can join
Adults 15 to 80, any sex, with Airway Management or Laryngeal Mask Airway. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A comparison of blind intubation with the intubating laryngeal mask FASTRACH™ and the intubating laryngeal mask Ambu Aura-i™ a prospective randomised clinical trial.
Schiewe R, Stoeck M, Gruenewald M, Hoecker J, et al · · 2019 · cited 3× · PMID 30927922 · DOI 10.1186/s12871-019-0718-6
Verify or expand the search:
- PubMed search for NCT03109678
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Airway Management
Currently open trials in the same condition.
- NCT07222007 — Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients · recruiting
- NCT07351227 — Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment · NA · recruiting
- NCT06955884 — Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation · recruiting
- NCT06954857 — The Influence of Standardized Process Management of Laryngeal Mask Airway Placement Based on Pressure Monitoring on the · NA · recruiting
- NCT06990490 — Application of Lateral Position Digestive Endoscopy-Guided Endotracheal Intubation in Anesthesia for Endoscopic Diagnosi · active not recruiting
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 NCT03109678 (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 Asklepios Kliniken Hamburg GmbH
- Last refreshed: 12 April 2017
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/NCT03109678.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing