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Search / Trial NCT05748782

BASKA Mask in Otologic Surgery in Lateral Position

Launched by ASSIUT UNIVERSITY · Feb 19, 2023

Trial Information

Current as of July 21, 2025

Unknown status

Keywords

ClinConnect Summary

This clinical trial is studying the use of a device called the BASKA mask for helping patients breathe during ear surgeries when they are positioned on their sides. The goal is to see if the BASKA mask works as well and is as safe as a more traditional method called endotracheal intubation. Researchers will measure different things during the surgery, such as how well patients can breathe and any possible complications that may arise.

To participate in this study, you need to be between 18 and 60 years old and have a surgery planned where general anesthesia will be used in the lateral position. However, if you have certain health issues, like severe heart or lung problems, or if you have a history of difficulties with breathing tubes, you may not be eligible. If you join the trial, you can expect to be closely monitored for your breathing and any side effects during the surgery. This research aims to improve airway management in surgeries, which is important for your safety and comfort.

Gender

ALL

Eligibility criteria

  • 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),

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Asyut, Assiut Governorate, Egypt

Patients applied

0 patients applied

Trial Officials

Hala S Abdel-Ghaffar, MD

Principal Investigator

Assiut University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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