- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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-
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Milan, Italia, 20136
- Rekruttering
- Istituto Neurologico Besta
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Ta kontakt med:
- Paolo Cortellazzi, MD
- Telefonnummer: 2420 +39022304
- E-post: paolo.cortellazzi@istituto-besta.it
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Underetterforsker:
- Alberto Sommariva, MD
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Milano, Italia, 20136
- Rekruttering
- Istituto Neurologico Besta
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Ta kontakt med:
- Massimo Lamperti, MD
- Telefonnummer: 2420 +39022394
- E-post: paolo.cortellazzi@istituto-besta.it
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Hovedetterforsker:
- Paolo Cortellazzi, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- any patient undergoing GA
Exclusion Criteria:
- patients with predicted difficult intubation undergoing awake intubation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
patients undergoing general anesthesia
every elective patient undergoing general anesthesia for neurosurgical procedures with endotracheal intubation
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intubation using Glidescope videolaryngoscope
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Features useful to define a Glidescope intubation successful
Tidsramme: 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
|
successfull intubation
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Paolo Cortellazzi, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- INCCB 2012-02
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