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

NCT ID: NCT03610126

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-26
• Study Completion Date: 2022-05-08

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

Conditions

Ventilation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

volume controlled ventilation

Intervention Type: PROCEDURE

the patients will be ventilated by volume controlled ventilation after insertion of the BASKA laryngeal mask airway

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

pressure controlled ventilation

Intervention Type: PROCEDURE

the patients will be ventilated by pressure controlled ventilation after insertion of the BASKA laryngeal mask airway

Interventions

volume controlled ventilation

the patients will be ventilated by volume controlled ventilation after insertion of the BASKA laryngeal mask airway

Intervention Type: PROCEDURE

pressure controlled ventilation

the patients will be ventilated by pressure controlled ventilation after insertion of the BASKA laryngeal mask airway

Intervention Type: PROCEDURE

Other Intervention Names

volume controlled; pressure controlled

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut university hospitals

Locations

Assiut university hospitals

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB: 17300212

Identifier Type: -

Identifier Source: org_study_id