- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01790646
Learning and Performance of Glidescope® Videolaryngoscope Intubation
Learning and Performance of Glidescope® Videolaryngoscope Intubation in Anesthesiologists Trained in Direct Laryngoscopy: a "in Vivo" Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Glidescope® Videolaryngoscope is an angulated rigid optical device introduced in clinical practice in 2004 to facilitate endotracheal intubation.
Since its introduction potential benefits of this instrument might lie with use in patients with clinical features indicating difficult laryngoscopy or it being used as a rescue method following failed direct laryngoscopy. In a few centers was proposed and used routinely.
The performance of Glidescope® was studied in easy and difficult scenarios, in vivo and on manikins and compared with the reference standard McIntosh direct laryngoscopy. In patients with predicted or simulated difficult intubation, despite glottis visualization was improved with Glidescope®, the introduction of the tube in trachea was difficult the same as with McIntosh laryngoscopy. Training of operators before to entertain the trials varied from 20 to 50 Glidescope successful intubations. In an observational study Aziz et al. demonstrated in the two Institutions involved that the GlideScope® was used more frequently at the Institution were the failure rate was significantly lower. At this , 51 providers performed mean 21.7 GlideScope® intubations while at the other 91 providers performed 9.9 intubations.
These data highlight the important issue of how many Glidescope® intubations a provider should complete to reach a definitive clinical competence in this practice. Until now there is only one study performed on mankin comparing Glidescope® with AirTraq® and McIntosh laryngoscopes in novices . The authors concluded that despite a steep learning curve after 5 intubation difficulties in instrumentation and longer times to intubate persisted with Glidescope® in comparison with the other two devices. Outcome measures were: duration of intubation attempt, modified Cormack grades, dental trauma and difficulty of use.
In vivo both timely insertion of laryngoscope blade and introduction of the tube, no need of help or of external laryngeal displacement should be included to ascertain expertise with this new technology in patients with different grades of difficulty predicted.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Milan, Italia, 20136
- Reclutamento
- Istituto Neurologico Besta
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Contatto:
- Paolo Cortellazzi, MD
- Numero di telefono: 2420 +39022304
- Email: paolo.cortellazzi@istituto-besta.it
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Sub-investigatore:
- Alberto Sommariva, MD
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Milano, Italia, 20136
- Reclutamento
- Istituto Neurologico Besta
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Contatto:
- Massimo Lamperti, MD
- Numero di telefono: 2420 +39022394
- Email: paolo.cortellazzi@istituto-besta.it
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Investigatore principale:
- Paolo Cortellazzi, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- any patient undergoing GA
Exclusion Criteria:
- patients with predicted difficult intubation undergoing awake intubation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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patients undergoing general anesthesia
every elective patient undergoing general anesthesia for neurosurgical procedures with endotracheal intubation
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intubation using Glidescope videolaryngoscope
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient
Lasso di tempo: from induction of GA to successful intubation
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from Glidescope blade insertion to succefull introduction of the tracheal tube and tube secured in the trachea with ETCO2 confirmation of tracheal ventilation
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from induction of GA to successful intubation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Features useful to define a Glidescope intubation successful
Lasso di tempo: successfull intubation
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the following criteria have to be satisfied: one introduction of the laryngoscope, one introduction of the tube, Cormack-leane 1, no external laryngeal displacement, time to intubation <43 seconds, no need for help of an external operator, no complications
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successfull intubation
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Paolo Cortellazzi, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- INCCB 2012-02
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su intubation
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The University of Texas Health Science Center,...KARL STORZ Endoscopy-America, Inc.CompletatoIntubazione, endotrachealeStati Uniti
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Samsun UniversityNon ancora reclutamentoAnestesia | Gestione delle vie aeree | Intubazione tracheale | Videolaringoscopia | Interventi chirurgici elettiviTurchia (Türkiye)