Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562, Egypt
NCT Number: NCT03384056
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.
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Notify Me18 year–55 year
Female
Observational
Cairo, 11562, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
used in adult low risk females undergoing elective gynecological operations
used in adult low risk females undergoing elective gynecological operations.
Time frame: one year
pressure at which leak starts to occur
Time frame: one year
detected by the flexible fiberoptic
Time frame: one year
is defined as time in seconds from the chosen device touching the teeth to the first recorded near rectangular capnogram curve in the presence of satisfactory bilateral chest expansion.
Reham Ali Abdelhaleem Abdelrahman
Other
Comparison of Air-Q Self Pressurized Airway Device With Blocker With Proseal Laryngeal Mask Airway in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations
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