Respiration and The Airway With Supraglottic Airway Devices
Condition: Laryngeal Masks Comparison
Study type: Observational

Summary: 
      The investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of
      the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway
      (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological
      operations. The investigators aim at assessment of fitting of both devices against the
      glottic region that detected by the flexible fiberoptic bronchoscope( Pentex Corporation,
      Medical Division, Singapore)and assessment of any associated postoperative complications.

      Hypothesis:

      The investigators hypothesize that the self-pressurized air-Q with blocker has a greater seal
      pressure compared to Proseal, easier and faster in insertion with less morbidity and
      complications during and after its insertion.
    

Detailed description: 
      The study will be carried on adult female patients to reduce variability in size of the
      chosen device to enable the investigators to analyze the performance parameters of the two
      devices with greater authority. The study will be done on anesthetized paralyzed adult female
      patients undergoing elective gynecological operations that require neuromuscular block but
      not necessarily tracheal intubation. The investigators will recruit 150 adult female(18-55
      years old, ASAI&II) patients to a prospective randomized comparative controlled two-arm
      parallel clinical trial. Patients with history of upper respiratory tract infections,
      obstructive sleep apnea, potentially full stomach (trauma, morbid obesity BMI> 35, pregnancy,
      history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus
      hernia), and those of coagulation disorders will be excluded from the study. All patients
      will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty
      of intubation and patients with airway scores ≥ 5 will be excluded from the study. The
      patients will be randomly allocated into two groups(the SP-Blocker group & the P-LMA group;
      each group is 75 patients) using computer generated program . An online randomization program
      (http://www.randomizer.org) will be used to generate random list and to allocate patients
      into the study groups. Random allocation numbers will be concealed in opaque closed envelops.
      The patient and investigator assessing study outcomes will all be blinded to the study groups
      allocation.
    

Intervention name(s): Self Pressurized Airway Device with Blocker; Proseal Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): used in adult low risk females undergoing elective gynecological operations; used in adult low risk females undergoing elective gynecological operations.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult female patients undergoing elective gynecological operations.