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

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ClinicalTrials.gov Identifier: NCT03610126
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University

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

Condition or disease Intervention/treatment
Ventilation Procedure: volume controlled ventilation Procedure: pressure controlled ventilation

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

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Efficacy of BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy Comparative Clinical Trial
Actual Study Start Date : August 26, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : December 15, 2019

Group/Cohort Intervention/treatment
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
the patients will be ventilated by volume controlled ventilation after insertion of the BASKA laryngeal mask airway
Other Name: volume controlled

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. End tidal carbon dioxide [ Time Frame: Intraoperative ]
    End tidal carbon dioxide measurement to determine efficacy of ventilation



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ASA I&II in the age range 20-60 years of both sexes and scheduled for elective laparoscopic cholecystectomy surgery
Criteria

Inclusion Criteria:

  • patients scheduled for elective cholecystectomy laparoscopic surgery.
  • Age: 20-60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610126


Contacts
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Contact: Hala S Abdel-Ghaffar, MD +2 01003812011 hallasaad@yahoo.com
Contact: amani abd elwahab, MD 01004610623 amanihassan1978@yahoo.com

Locations
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Egypt
Assiut university hospitals Recruiting
Assiut, Assiut Governorate, Egypt, Egypt,71571
Contact: Hala S Abdel-Ghaffar, MD    +01003812011    hallasaad@yahoo.com   
Contact: Amani Hassan abdel-wahab, MD    +01004610623    amanihassan1976@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Hala S Abdel-Ghaffar, MD Assiut university hospitals

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Responsible Party: Hala Saad Abdel-Ghaffar, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03610126     History of Changes
Other Study ID Numbers: IRB: 17300212
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hala Saad Abdel-Ghaffar, Assiut University:
BASKA mask
controlled ventilation