Clinical trial NCT03610126: BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy
Official title: Comparison of Efficacy of BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy Comparative Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation
Keywords: BASKA mask
controlled ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA I\&II in the age range 18-60 years of both sexes and scheduled for elective laparoscopic cholecystectomy surgery

Brief summary: this study will be undertaken to compare the efficacy of BASKA mask in volume controlled and pressure controlled ventilation in laparoscopic cholecystectomy.

Detailed description: Laparoscopic cholecystectomy is one of the most commonly performed surgical procedures and the laryngeal mask airway (LMA) is the most common supraglottic airway device used by the anesthesiologists to manage airway during general anesthesia. Use of LMA has some advantages when compared to endotracheal intubation, such as quick and ease of placement, a lesser requirement for neuromuscular blockade and a lower incidence of postoperative morbidity. However, the use of the LMA in laparoscopy is controversial, based on a concern about increased risk of regurgitation and pulmonary aspiration. The ability of these devices to provide optimal ventilation during laparoscopic procedures has been also questioned. The most important parameter to secure an adequate ventilation and oxygenation for the LMA under pneumoperitoneum condition is its seal pressure of airway The BASKA mask is a novel supraglottic airway device. It has many of the features of other supraglottic airways, These include; A non-inflatable cuff, that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation more efficient

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective cholecystectomy laparoscopic surgery.
* Age: 18-60 years.
* ASA physical status: I-II.

Exclusion Criteria:

* Patient refusal.
* History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
* Patients who have high risk of regurgitation or aspiration based on history of gastro esophageal reflux, hiatus hernia, diabetes and gross obesity.
* Neck pathology.
* Patients who predicted difficult airway (based on a history of difficult airway, mouth opening was less than 2.5 cm, inter-incisor distance \< 20 mm, cervical spine pathology, modified Mallampati class III/IV, or thyromental distance \< 65 mm).
* Preoperative sore throat.

Primary outcomes:
measure: oropharyngeal leak pressure
timeFrame: Intra-operative
Secondary outcomes:
measure: End tidal carbon dioxide
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut Governorate
Study officials:
affiliation: Assiut university hospitals
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: