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CompletedNCT03610126Updated May 10, 2022

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

An observational study in Ventilation, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-05-10.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Ventilation

Keywords

  • BASKA mask
  • controlled ventilation
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  • patients scheduled for elective cholecystectomy laparoscopic surgery.
  • Age: 18-60 years.
  • ASA physical status: I-II.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Procedurevolume controlled ventilation

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

    Also known as: volume controlled

  • Procedurepressure controlled ventilation

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

    Also known as: pressure controlled

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Intra-operative

Secondary outcomes

  1. End tidal carbon dioxide

    End tidal carbon dioxide measurement to determine efficacy of ventilation

    Time frame: Intraoperative

07

Study locations

1 site
  • Assiut university hospitals
    Assiut, Assiut Governorate Egypt,71571, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03610126
Lead sponsor
Assiut University
Responsible party
Hala Saad Abdel-Ghaffar (Principal Investigator, Assiut University) — Principal investigator
First posted
Aug 1, 2018
Start date
Aug 26, 2018
Primary completion
May 8, 2022
Completion
May 8, 2022
Last update
May 10, 2022

Study contacts

Hala S Abdel-Ghaffar, MD
principal investigator · Assiut university hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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