Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i

Cairo University (CU) logo

Cairo University (CU)

Status

Invitation-only

Conditions

The Baska Mask

Treatments

Device: airway divice

Study type

Interventional

Funder types

Other

Identifiers

NCT05363566
N-49-2021

Details and patient eligibility

About

The Baska mask (proact Medical Ltd, Northants, UK) is the latest addition to an era of supraglottic airway devices in clinical use. It is made of medical grade silicone; it has many advantages in its constructions over other LMA, a cuff less membranous bowl in which the saliva secretion collected. An inbuilt "tab" that allows to extend its angulation for straightforward negotiation of the oropharyngeal curve during placement

Enrollment

78 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Adult patients from 18 to 60 years of age.
  • American Society of Anesthesiologists (ASA) physical status I and II
  • Both genders
  • Patients scheduled for elective surgeries lasting less than 2 hours under general anesthesia on spontaneous ventilation.
  • El Ganzouri index Score ≥ 4
  • Patients with BMI < 35 kg/m2

Exclusion criteria

  • The patients who will be refusal or inability to give informed consent,
  • ASA class III or IV
  • El Ganzouri index Score < 4,
  • Oropharyngeal pathology making a proper SAD fit unlikely as weak dentation, neck pathology
  • Respiratory illness including upper respiratory infection or pneumonia within the six weeks preceding surgery
  • Risk for gastric aspiration (e.g., hiatus hernia, gastro-oesophageal reflux disease or non-fasting status), expected duration of surgery longer than 2 h
  • Contraindication to SGA use including morbid obesity (body mass index 35 kg m-1, history of obstructive sleep apnea)
  • Any condition for which the primary anesthesia team deemed intubation with a tracheal tube to be necessary.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

78 participants in 3 patient groups

group I
Active Comparator group
Description:
will be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK)
Treatment:
Device: airway divice
group II
Active Comparator group
Description:
will be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK)
Treatment:
Device: airway divice
group III (SP Air-Q) (n = 26)
Active Comparator group
Description:
will be inserted Single use supraglottic airway (self-pressurized Air-Q intubating laryngeal airway (Air-Q SP®)) (Mercury Medical, Clearwater, FL, USA)
Treatment:
Device: airway divice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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