BASKA Mask in Otologic Surgery in Lateral Position

NCT05748782 | Unknown DMC

• 1 other identifier: BASKA mask in otologic surgery
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Oropharyngeal leak pressure

  Intraoperative

• Ventilation Score

  Intraoperative

• Fiberoptic Glottic Score

  Intraoperative

Study Arms (2)

BASKA GROUP

the BASKA mask will be inserted, and its size will be chosen according to the manufacturer's weight-based recommendations.

Other: Baska Mask

ETT GROUP

Patients in this group will be anesthetized using an endotracheal tube of appropriate size.

Device: Endotracheal tube

Interventions

Baska Mask OTHER

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.

BASKA GROUP

Endotracheal tube DEVICE

BASKA Mask

Also known as: ETT

ETT GROUP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients 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.

You may qualify if:

• Age group 18 - 60 years old.
• Both genders.
• 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

You may not qualify if:

• Patient refusal,
• History of cardiac or respiratory disease, psychological disorders,
• High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity,
• neck pathology,
• 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),

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Main Assiut University Hospital

Asyut, Assiut Governorate, 71515, Egypt

RECRUITING

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed G Esmael, MBBCH

CONTACT

01143187593; drahmedgamal127@gmail.com

Hala S Abdel-Ghaffar, MD

CONTACT

01003812011; hallasaad@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: July 23, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)