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Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients

15 mars 2013 mis à jour par: John Laffey

The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.

The investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. This trial will compare some performance characteristics of the studied devices, including airway seal pressures, insertion success rates, device use difficulty scores. Additional performance and device safety data will be accumulated.

The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask vs LMA.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Supraglottic airway devices have established place in the airway management in patients undergoing general anesthesia.

The Baska mask is a new supraglottic airway device. It's features include:

  1. Non pressurized cuff designed to reduce the risk of oropharyngeal tissue damage.
  2. Improved cuff seal during the inspiratory phase of positive pressure ventilation
  3. An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
  4. Integrated bite-block to reduce the risk of patients biting and blocking the airway.

This study is randomized, single-blinded, controlled trial. The participants will be allocated to two groups, in which either the Baska mask or the single use LMA will be the primary airway management device.

Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.

Standard anesthetic preassesment and anesthesia will be provided.

Consenting patients will be randomly allocated to either of the 2 study groups.

Protocol for airway size selection and attempts at placement will be followed.

The investigators will monitor a number of parameters, including time and ease of insertion, airway seal pressure, airway leak, complications related to device use and other.

Follow up will be performed.

The investigators have two primary hypotheses:

  1. That the Baska mask is non-inferior to LMA in respect if first placement attempt success rate. A greater than 15% difference in success rate will be considered a clinically important difference and will disprove this hypothesis.
  2. The Baska mask is superior in respect of seal pressure. A 20% higher seal pressure with Baska as compared to the LMA device seal pressure will be considered a clinically important difference.

Interim analysis will be performed once 75 patients are recruited per group. This is reasonable as this figure exceeds that required to prove or disprove the primary hypothesis regarding the seal pressure. The study will only be stopped at this stage if the non-inferiority hypothesis is disproven with P value < 0.01

In addition to the above the investigators will evaluate a number of secondary outcomes.

Type d'étude

Interventionnel

Inscription (Réel)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Irlande
      • Galway, Irlande
        • Galway University Hospitals

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

16 ans à 85 ans (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Female
  • Written informed consent
  • ASA 1-3
  • No relevant allergies
  • Body-mass index (BMI) 35 or less
  • Age 16-85
  • Non-urgent surgery of planned duration under 4 hours

Exclusion Criteria:

  • Inability of patient/parent to understand or consent for the trial
  • Neck pathology
  • Previous or anticipated problems with the upper airway or upper GI tract
  • BMI >35
  • Predicted or previously documented difficult airway
  • Live Pregnancy
  • Increased risk for Gastric Aspiration

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Baska mask
In this arm the Baska mask will be used as the airway management device
Dispositif: supraglottic airway placement and use
Comparateur actif: single use laryngeal mask airway device (LMA)
in this arm a single use LMA device will be used for airway management.
Dispositif: supraglottic airway placement and use

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Rate of successful placement of the supraglottic device on first attempt
Délai: within 30 minutes of commencement of general anesthesia
The hypothesis is that the Baska mask will have first time placement attempt success rate that is no more than 15% less than that of the comparator - a single use LMA device.
within 30 minutes of commencement of general anesthesia
Seal pressure of the supraglottic device
Délai: Within 30 minutes of commencement of general anesthesia
The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure of the Baska mask is 20% higher than that of the comparator single-use LMA device.
Within 30 minutes of commencement of general anesthesia

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall rate of successful placement of the supraglottic device
Délai: Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.
Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.
Number of device placement attempts
Délai: Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
Number of optimization maneuvers during device placement
Délai: Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
user rated Device difficulty score
Délai: within 30 minutes of commencement of general anesthesia
the investigators will use 10 cm visual analogue scale to score the whole experience of using the device until successful ventilation is achieved.
within 30 minutes of commencement of general anesthesia
vitals parameter stability
Délai: in the period immediately before and within the first 35 minutes of general anesthesia
The investigators will record non-invasive arterial oxygen saturation, heart rate and blood pressure preoperatively, after induction of general anesthesia and after placement of the airway device.
in the period immediately before and within the first 35 minutes of general anesthesia
Laryngeal view obtained on fiberoptic assessment
Délai: within 2 hours of commencement of general anesthesia
The investigators will perform this when feasible.
within 2 hours of commencement of general anesthesia
Complication rates
Délai: from the moment general anesthesia commenced up to 3 days postoperatively

Complications specifically monitored will be: blood staining, laryngospasm, lip damage, throat pain, dysphagia, dysphonia, heartburn, nausea and vomiting.

The investigators will record other complications related to the use of the device, including but not limited to: desaturation, need to reposition device or switch to alternative device, teeth damage, regurgitation, aspiration
from the moment general anesthesia commenced up to 3 days postoperatively

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

John Laffey

Les enquêteurs

  • Chercheur principal: Patrick Neligan, FFARCSI, Galway University Hospitals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2012

Achèvement primaire (Réel)

1 janvier 2013

Achèvement de l'étude (Réel)

1 janvier 2013

Dates d'inscription aux études

Première soumission

17 décembre 2012

Première soumission répondant aux critères de contrôle qualité

17 décembre 2012

Première publication (Estimation)

20 décembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 mars 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mars 2013

Dernière vérification

1 mars 2013

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • C.A.724

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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