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Clinical Trials/NCT03610126
NCT03610126
Completed
Not Applicable

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

Assiut University1 site in 1 country56 target enrollmentAugust 26, 2018
ConditionsVentilation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilation
Sponsor
Assiut University
Enrollment
56
Locations
1
Primary Endpoint
oropharyngeal leak pressure
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 26, 2018
End Date
May 8, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hala Saad Abdel-Ghaffar

Principal Investigator

Assiut University

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.

Outcomes

Primary Outcomes

oropharyngeal leak pressure

Time Frame: 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 Outcomes

  • End tidal carbon dioxide(Intraoperative)

Study Sites (1)

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