BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy

Completed

• Conditions: Ventilation
• Interventions: Procedure: pressure controlled ventilation; Procedure: volume controlled ventilation

• Registration Number: NCT03610126
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Study Start: 2018-08-26
• Status Verified: 2022-05
• Primary Completion: 2022-05-08
• Study Completion: 2022-05-08
• Last Update Submitted: 2022-05-08
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pressure controlled ventilation	pressure controlled ventilation	after induction of anesthesia and insertion of BASKA laryngeal mask airway and mechanical ventilation of patients will be maintained with pressure controlled ventilation mode
volume controlled ventilation	volume controlled ventilation	after induction of anesthesia and insertion of BASKA laryngeal mask airway mechanical ventilation of patients will be maintained with volume controlled ventilation mode

Primary Outcome Measures

Name	Time	Method
oropharyngeal leak pressure	Intra-operative	the oropharyngeal leak airway pressure will be used as a primary outcome to compare the efficacy of BASKA mask in volume controlled and pressure controlled ventilation in laparoscopic cholecystectomy and measuring leak pressure.

Secondary Outcome Measures

Name	Time	Method
End tidal carbon dioxide	Intraoperative	End tidal carbon dioxide measurement to determine efficacy of ventilation

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Assiut Governorate, Egypt