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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03610126
Enrollment
56
Registered
2018-08-01
Start date
2018-08-26
Completion date
2022-05-08
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation

Keywords

BASKA mask, controlled ventilation

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

Interventions

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

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
oropharyngeal leak pressureIntra-operativethe 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

MeasureTime frameDescription
End tidal carbon dioxideIntraoperativeEnd tidal carbon dioxide measurement to determine efficacy of ventilation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026