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NCT03539185
Airtraq Versus Fiberoptic for Awake Tracheal Intubation
NA trial testing Videolaryngoscope Airtraq in Intubation;Difficult in 78 participants. Completed in 18 May 2020.
18 May 2020
Quick facts
| Lead sponsor | University Hospital, Caen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 78 |
| Start date | 1 June 2018 |
| Primary completion | 18 May 2020 |
| Estimated completion | 18 May 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Videolaryngoscope Airtraq
- Fiberoptic bronchoscope
Conditions studied
- Intubation;Difficult — all drugs for Intubation;Difficult →
- Awake Intubation — all drugs for Awake Intubation →
- Airway Complication of Anesthesia — all drugs for Airway Complication of Anesthesia →
Sponsor
University Hospital, Caen
Who can join
18 and older, any sex, with Intubation;Difficult or Awake Intubation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The airway management is a vital act in anesthesia. The gold standard technique for planned very difficult intubation is nasotracheal fiberoptic intubation. The success rate with this procedure is 98.8%. However, learning this technique is difficult and it's considered uncomfortable by patients and practitioners. The Airtraq® videolaryngoscope is commonly used for difficult orotracheal intubation. Cases of awake intubation by Airtraq® have been described. Furthermore, the French Society of Anesthesia-Resuscitation, in its last formalized expert recommendations (2017) on difficult intubation, proposes the use of video laryngoscopes as an alternative to the fiberoptic bronchoscope. We propose a non-inferiority study evaluating the use of Airtraq® for the realization of a awake intubation compared to the gold standard (fiberoptic bronchoscope). This prospective randomized study should include 78 patients in two groups. The purpose of this study is to improve the comfort of patient and practitioner during an awake tracheal intubation, to facilitate the learning of the technique.
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 NCT03539185
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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 NCT03539185 (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 University Hospital, Caen
- Last refreshed: 19 October 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/NCT03539185.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing