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

Comparison of Efficacy of BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy Comparative Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Ventilation
• Intervention / Treatment: Procedure: volume controlled ventilation; Procedure: pressure controlled ventilation

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 Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Egypt
  • Assiut Governorate
    • Assiut, Assiut Governorate, Egypt, Egypt,71571
      • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: volume controlled ventilation; the patients will be ventilated by volume controlled ventilation after insertion of the BASKA laryngeal mask airway; Other Names: volume controlled
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	Procedure: pressure controlled ventilation; the patients will be ventilated by pressure controlled ventilation after insertion of the BASKA laryngeal mask airway; Other Names: pressure controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oropharyngeal leak pressure	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.	Intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End tidal carbon dioxide	End tidal carbon dioxide measurement to determine efficacy of ventilation	Intraoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdel-Ghaffar, MD, Assiut University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2018
• Primary Completion (Actual): May 8, 2022
• Study Completion (Actual): May 8, 2022

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: BASKA mask; controlled ventilation
• Other Study ID Numbers: IRB: 17300212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No