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Search / Trial NCT06945029

A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population

Launched by CAIRO UNIVERSITY · Apr 24, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two medical devices, the Laryseal Pro and the Ambu Aura Gain, to see which one works better for helping doctors place a breathing tube in children during surgery. This process is important for ensuring that children can safely receive anesthesia for procedures that last more than one hour. Researchers will compare how long it takes to successfully place the breathing tube using each device.

To participate in this study, children must be between 4 and 8 years old and generally healthy, without any major head or neck issues or conditions that might make breathing difficult. The study is currently looking for volunteers, and parents can expect their child to be carefully monitored throughout the process. If a child has certain medical conditions or allergies, they may not be eligible to join the trial. Overall, this research aims to find the best method for ensuring safe breathing during surgeries for young patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age starting from 4 years to 8 years.
  • Both genders.
  • ASA physical status class I-ll.
  • Apparently anatomically normal with normal percentile growth chart, not suspected to have difficult airway.
  • Scheduled for day case surgeries more than one hour under general anesthesia.
  • Exclusion Criteria:
  • Parents refusal.
  • Abnormality in head and neck or craniofacial anomalies as Piere Robbin syndrome, facial trauma, head and neck tumours, swellings and hemangiomas.
  • Patients at risk of regurgitation and pulmonary aspiration such as patients with hiatus hernia, GERD or DM.
  • Abnormal or contraindicated cervical spine flexion/extension/rotation.
  • Allergy to any EAD components.
  • Any active respiratory or cardiac disease and metabolic disorders.

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Cairo, Giza, Egypt

Patients applied

0 patients applied

Trial Officials

Jehan A El-kholy, Professor

Study Chair

Cairo University

Maha M.I Youssef, Assistant Professor

Study Director

Cairo University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported