BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

NCT03287752 | Completed DMC

• 1 other identifier: 17100178
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel supraglottic airway device. It has many of the features of other supraglottic airways, with a number of innovations. 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.

Conditions

Ventilation

Outcome Measures

Primary Outcomes (1)

• Peak airway pressure

  Peak airway pressure before and after abdominal inflation.

  6 hours including preoperative, intraoperative and 4h after operation

Study Arms (2)

BASKA MASK

Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant.

Device: BASKA MASK

Endotracheal tube

Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT.

Device: Endotracheal tube

Interventions

BASKA MASK DEVICE

Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant

Also known as: BASKA

BASKA MASK

Endotracheal tube DEVICE

Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.

Also known as: ETT

Endotracheal tube

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: females 18-60years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female patients scheduled for elective gynecological laparoscopic surgery.

You may qualify if:

• Sex: Female patients scheduled for elective gynecological laparoscopic surgery.
• Age: 18-60 years.
• BMI\< 30kg/m2.
• ASA physical status: I-II.
• Operation: gynecological laparoscopic surgery under general anesthesia of an anticipated duration\<1h.

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).
• Allergy to any of the anesthetic agents used.
• The possibility of being pregnant.
• Heavy smoker.
• Preoperative sore throat.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

women health hospital, Assiut university

Asyut, Assiut Governorate, 715715, 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 Abdelghaffar, MD

  Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 19, 2017
• Study Start: September 14, 2017
• Primary Completion: December 29, 2019
• Study Completion: December 29, 2019
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)