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

NCT03610126 | Completed DMC

• 1 other identifier: IRB: 17300212
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilation

Keywords

BASKA mask; controlled ventilation

Outcome Measures

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.

  Intra-operative

Secondary Outcomes (1)

• End tidal carbon dioxide

  Intraoperative

Study Arms (2)

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

volume controlled ventilation PROCEDURE

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

Also known as: volume controlled

volume controlled ventilation

pressure controlled ventilation PROCEDURE

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

Also known as: pressure controlled

pressure controlled ventilation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Assiut Governorate, Egypt,71571, Egypt

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assiut university hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 1, 2018
• Study Start: August 26, 2018
• Primary Completion: May 8, 2022
• Study Completion: May 8, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

EG (1)