Clinical trial NCT03384056: Respiration and The Airway With Supraglottic Airway Devices
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Masks Comparison
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult female patients undergoing elective gynecological operations.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult female patients ASA I\&II
* Age: 18- 55 years old
* BMI \< 35
* Undergoing elective gynecological operations.

Exclusion Criteria:

* Patients with history of upper respiratory tract infections and obstructive sleep apnea.
* Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
* Patients with coagulation disorders.
* Patients with El-Ganzouri airway score ≥ 5 will.

Primary outcomes:
measure: airway seal pressure
timeFrame: one year
measure: fitting of the device against larynx
timeFrame: one year
Secondary outcomes:
measure: insertion time of the device
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia, Surgical ICU, and Pain Management
Study officials:
References: