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

15. mars 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Irland
      • Galway, Irland
        • Galway University Hospitals

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 85 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Baska mask
In this arm the Baska mask will be used as the airway management device
Enhet: supraglottic airway placement and use
Aktiv komparator: single use laryngeal mask airway device (LMA)
in this arm a single use LMA device will be used for airway management.
Enhet: supraglottic airway placement and use

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of successful placement of the supraglottic device on first attempt
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall rate of successful placement of the supraglottic device
Tidsramme: 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
Tidsramme: Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
Number of optimization maneuvers during device placement
Tidsramme: Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
user rated Device difficulty score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

John Laffey

Etterforskere

  • Hovedetterforsker: Patrick Neligan, FFARCSI, Galway University Hospitals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2012

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

17. desember 2012

Først innsendt som oppfylte QC-kriteriene

17. desember 2012

Først lagt ut (Anslag)

20. desember 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. mars 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2013

Sist bekreftet

1. mars 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • C.A.724

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