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Videolaryngoscopes for Double Lumen Tube Intubations in Simulated Easy and Difficult Airway

24 dicembre 2015 aggiornato da: Imam Abdulrahman Bin Faisal University

A Comparison of Three Videolaryngoscopes for Double-lumen Tubes Intubation in Simulated Easy and Difficult Airways

The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. The investigators have considered to assess the efficacy of each device in manikins before considering to evaluate them in patients undergoing thoracic procedures.

Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT intubation participated in this randomised crossover study. Following a brief demonstration and two practice attempts, participants were volunteered to insert a DLT using the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an attempt took longer than 150 seconds, were recorded.

Panoramica dello studio

Descrizione dettagliata

Several regional surveys demonstrated that most thoracic anesthesiologists are using the double-lumen endobronchial tubes (DLT) as the first-choice lung separation technique. DLT, when compared with single lumen tracheal tube, can be more difficult to insert in patients with difficult airways. The videolaryngoscopes (VL) have the potential to facilitate the placement of the DLTs for lung separation in patients with predicted or unanticipated difficult airway.

The use of GlideScope® (Verathon Inc., Bothell, WA, USA), a VL with an angulated blade, has been associated with variable times to DLT intubation according to the prior experience of the operators, despite superior visualization of the glottis The channeled Airtraq® (Prodol Meditec S.A., Vizcaya, Spain) and standard non-channeled blade of the King Vision™ (Ambu, Ballerup, Copenhagen, Denmark), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT. Of note, the longer times to DLT intubation with the use of different VL could be shortened with building up the operator's experience.

To the best of the investigators knowledge, the comparison of the effects of the Macintosh, GlideScope®, Airtraq®, and King Vision™ VL on the time to DLT intubation in simulated easy and difficult airways has not yet been studied.

Two high-fidelity simulators (Airway Management Trainer, model AA-3100, Laerdal, Kent, UK) were prepared to simulate easy and difficult airway situations, as described by Marshall et al. and Wang et al. The "easy" airway was established with the manikin in a neutral position. The "difficult" airway setting was obtained by placing an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA) under the occiput and securing the head position with adhesive tape, object to replicate cervical-collar use. Positioning was confirmed after each attempt to ensure consistency.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • EP
      • Al-Khobar, EP, Arabia Saudita, 31952
        • Dammam University KFHU

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 23 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Staff anesthesiologists
  • Signed consent
  • Limited experience in using videolaryngoscopes for inserting double lumen tubes

Exclusion Criteria:

  • Decline to sign the consent
  • Non receiving the prior training demonstration
  • Non practicing once with each device tested on each simulator scenario

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Macintosh
The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator
Comparatore placebo: GlideScope
The participants intubated the easy airway simulator with a double lumen tube using the GlideScope laryngoscope followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the GlideScope followed with intubating the difficult airway simulator
Comparatore attivo: Airtraq
The participants intubated the easy airway simulator with a double lumen tube using the Airtraq laryngoscope followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the Airtraq followed with intubating the difficult airway simulator
Comparatore attivo: King Vision
The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator
The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to achieve successful double lumen tube intubation
Lasso di tempo: for 6 min after using each device
defined as the time when the investigated laryngoscope passed the central incisors to when the tip of the bronchial lumen passed through the glottis, as confirmed visually by the operator (in the Macintosh group) or by the investigator, thanks to remote screens (in the VLs groups).
for 6 min after using each device

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Best view during laryngoscopy using the classification described by Cormack and Lehane
Lasso di tempo: for 1 min after laryngoscopy
using the classification described by Cormack and Lehane
for 1 min after laryngoscopy
Difficulty of intubation using a Visual Analog Scale (VAS)
Lasso di tempo: for 6 min after using each device
The difficulty of intubation was evaluated using a visual analog scale (VAS) (ranging from 0: extremely easy, to 100: extremely difficult) expressed by the anesthesiologists after the DLT intubation
for 6 min after using each device
Number of first-pass success
Lasso di tempo: for 3 min after using each device
first-pass success calculated as number of first-attempt successes/number of patients with an intubation attempt
for 3 min after using each device
Number of the required optimisation manoeuvers
Lasso di tempo: for 6 min after using each device
When the anaesthesiologists encountered difficulty in visualising vocal cords or placing the tube, they were allowed to use any manoeuver they would normally use to navigate the tube into the trachea including readjustment of the blade or tube or to ask the supervising investigator to help solve the problem, and gave suggestions or instructions
for 6 min after using each device

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mohamed R El Tahan, MD, Anesthesiology Department, Dammam University, Dammam, Saudi Arabia
  • Direttore dello studio: Abdulmohsen A Al Ghamdi, MD, Anesthesiology Department, Dammam University, Dammam, Saudi Arabia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2015

Completamento primario (Effettivo)

1 maggio 2015

Completamento dello studio (Effettivo)

1 giugno 2015

Date di iscrizione allo studio

Primo inviato

22 dicembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

24 dicembre 2015

Primo Inserito (Stima)

28 dicembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 dicembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 dicembre 2015

Ultimo verificato

1 dicembre 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ANESTH-03-15

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

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