BASKA Mask in Otologic Surgery in Lateral Position

Airway Device Clinical Trial

— BASKAvsETT  

Official title:

Efficiency and Safety of BASKA Mask Ventilation in Comparison With Endotracheal Intubation During Otologic Surgery in the Lateral Head and Neck Position

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748782
• Other study ID #: BASKA mask in otologic surgery
• Status: Recruiting
• Start date: July 23, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Ahmed G Esmael, MBBCH
• Phone: 01143187593
• Email: drahmedgamal127[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the Efficiency and safety of BASKA mask ventilation in comparison with endotracheal intubation during otologic surgery performed with the head and neck in the lateral position. The primary outcome will be the intraoperative peak inspiratory pressure (PIP). Secondary outcomes will be intraoperative lung mechanics, oropharyngeal leak pressure (OLP), ventilation score, fiberoptic glottic view score, and perioperative adverse effects.

Description:

The laryngeal mask airway (LMA) was invented in 1981 by Dr Brain Because of its advantages, LMAs are increasingly used as a substitute for endotracheal tubes in a variety of surgical situations requiring general anesthesia. With the appearance of various new LMAs that address the limitations of the classic model, not only has their use in selective operations increased, but the indications for LMA have also grown LMAs can be inserted into the hypopharynx easily without laryngoscopy and neuromuscular blocking agents, and they can also be removed from the patient's mouth quickly. Decreasing airway irritation during surgery results in fewer hemodynamic changes and airway accidents from anesthesia and enables wakeup with less coughing and bucking, which could result in less ossicular replacement prosthesis displacement . In middle ear/mastoid procedures, because the operation involves the temporal bone, including the surrounding normal nerves and blood vessels, improper manipulation can lead to complications such as facial paralysis; therefore, the operation needs to be performed carefully. Compared to endotracheal intubation, LMAs have little effect on middle ear pressure . These advantages make anesthesiologists prefer LMAs during otologic surgery. In addition, since LMAs can reduce the response to upper airway stimulation, they can be used as an airway device during surgery requiring facial nerve monitoring without the use of muscle relaxants . However, the points of contention and primary disadvantages of the use of LMA are the reduced levels of airway protection, the increased risk of gastric insufflation, the difficulty of insertion, partial upper airway obstruction and the possibility of dislocation during the procedure . To expose the operative field, otologists usually require the patient's head be rotated 60°~90° to the healthy side. Some studies have reported that the head and neck position can affect the sealing and ventilation functions of LMAs and the fiberoptic view . The Baska mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a supraglottic airway device introduced in 2012 with many innovations that might be expected to overcome these derangements . First, its' non-inflatable cuff is continuous with the central channel of the device and automatically inflates during positive pressure ventilation in response to the increased inflation pressure. This inflation produces an oropharyngeal leak pressure higher than that produced by other LMAs, enabling more effective ventilation. Second, it has an esophageal drainage inlet and side channels that comprise an efficient pharyngeal drainage system which facilitates aspiration of gastric contents, thereby reducing the risk of gastric overinflation and pulmonary aspiration. Third, a strong integrated bite-block that acts as a safeguard against obstruction of the Baska mask. In this study, the hypothesis is that these modifications might enable the Baska mask to become a reasonable and safe alternative to the endotracheal intubation in during otologic surgery performed with the head and neck in the lateral position.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age group 18 - 60 years old.

2. Both genders.

3. Undergoing general anesthesia for ear surgeries in the lateral neck position (60-90 degrees) in whom BASKA mask can be a suitable device for airway management

Exclusion Criteria:

1. Patient refusal,

2. History of cardiac or respiratory disease, psychological disorders,

3. High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity,

4. neck pathology,

5. Predicted difficult airway (history of difficult airway, mouth opening <2.5cm, Modified Mallampati class III/IV, thyro-mental distance <6.5cm or cervical spine pathology),

Related Conditions & MeSH terms

• Airway Device

Intervention

Other:
• Baska Mask
The Baska mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a supraglottic airway device introduced in 2012 with many innovations that might be expected to overcome these derangements.

Device:
• Endotracheal tube
BASKA Mask

Locations

Country	Name	City	State
Egypt	Main Assiut University Hospital	Asyut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the intraoperative peak inspiratory pressure (PIP)	the peak inspiratory pressure will be measured from the panel of the ventilator electronic box (Datex-Ohmeda,Inc 3030 Ohmeda Drive PO Box 7550 )	Intraoperative
Secondary	Oropharyngeal leak pressure	The fresh gas flow will be adjusted to 3 l/min, and the electronic APL valve is set automatically at 30 cmH2O, the airway pressure rises until attaining a plateau that is equal to the total leak pressure of the LMA with an upper limit of airway pressures 40 cm H2O. The airway pressure at which an audible leak is detected at the mouth and auscultated by placing the stethoscope over the patient's neck just lateral to the thyroid cartilage will be recorded as the oropharyngeal leak pressure (OLP) .	Intraoperative
Secondary	Ventilation Score	The ventilation score which will be scored from 0 to 3 based on three criteria: no leakage with an airway pressure of 15 cm H2O, bilateral chest excursions with a peak inspiratory pressure of 20 cm of H2O, and a square wave capnography, with each item scoring 0 or 1 point.	Intraoperative
Secondary	Fiberoptic Glottic Score	position of the device concerning the glottis will be investigated by inserting a fiberoptic laryngoscope (11301BNX, diameter 5.5 mm; length 65 cm; Karl Storz, Tuttlingen, Germany) will be inserted through the mask to evaluate the glottic view. Oxygen will be administered through the suction port throughout the procedure. Fiberoptic images will be graded with Brimacombe score that ranges from one to five; (grade1= only larynx seen, grade 2=larynx and epiglottis posterior surface seen, grade 3=larynx and epiglottis tip of anterior surface seen, 50% visual obstruction of epiglottis to larynx and grade 5, i.e. epiglottis down folded and larynx cannot be seen directly.	Intraoperative