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

Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610126
• Other study ID #: IRB: 17300212
• Status: Completed
• Start date: August 26, 2018
• Est. completion date: May 8, 2022

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 8, 2022
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ventilation

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End tidal carbon dioxide	End tidal carbon dioxide measurement to determine efficacy of ventilation	Intraoperative