- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Milan, Italien, 20136
- Rekrytering
- Istituto Neurologico Besta
-
Kontakt:
- Paolo Cortellazzi, MD
- Telefonnummer: 2420 +39022304
- E-post: paolo.cortellazzi@istituto-besta.it
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Underutredare:
- Alberto Sommariva, MD
-
Milano, Italien, 20136
- Rekrytering
- Istituto Neurologico Besta
-
Kontakt:
- Massimo Lamperti, MD
- Telefonnummer: 2420 +39022394
- E-post: paolo.cortellazzi@istituto-besta.it
-
Huvudutredare:
- Paolo Cortellazzi, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- any patient undergoing GA
Exclusion Criteria:
- patients with predicted difficult intubation undergoing awake intubation
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
patients undergoing general anesthesia
every elective patient undergoing general anesthesia for neurosurgical procedures with endotracheal intubation
|
intubation using Glidescope videolaryngoscope
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient
Tidsram: from induction of GA to successful intubation
|
from Glidescope blade insertion to succefull introduction of the tracheal tube and tube secured in the trachea with ETCO2 confirmation of tracheal ventilation
|
from induction of GA to successful intubation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Features useful to define a Glidescope intubation successful
Tidsram: successfull intubation
|
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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Paolo Cortellazzi, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- INCCB 2012-02
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