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

15 maart 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Ierland
      • Galway, Ierland
        • Galway University Hospitals

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar tot 85 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Baska mask
In this arm the Baska mask will be used as the airway management device
Apparaat: supraglottic airway placement and use
Actieve vergelijker: single use laryngeal mask airway device (LMA)
in this arm a single use LMA device will be used for airway management.
Apparaat: supraglottic airway placement and use

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of successful placement of the supraglottic device on first attempt
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall rate of successful placement of the supraglottic device
Tijdsspanne: 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
Tijdsspanne: Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
Number of optimization maneuvers during device placement
Tijdsspanne: Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
user rated Device difficulty score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

John Laffey

Onderzoekers

  • Hoofdonderzoeker: Patrick Neligan, FFARCSI, Galway University Hospitals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2012

Primaire voltooiing (Werkelijk)

1 januari 2013

Studie voltooiing (Werkelijk)

1 januari 2013

Studieregistratiedata

Eerst ingediend

17 december 2012

Eerst ingediend dat voldeed aan de QC-criteria

17 december 2012

Eerst geplaatst (Schatting)

20 december 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

19 maart 2013

Laatste update ingediend die voldeed aan QC-criteria

15 maart 2013

Laatst geverifieerd

1 maart 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • C.A.724

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