AuraGain Performance in Lateral Position

NCT05106478 | Completed DMC

• 1 other identifier: 17101416
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the clinical performance of AuraGain including insertion time and success rate at first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease of gastric tube insertion, and peri-operative adverse effects in young children in supine, moderate lateral and extreme lateral position.

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure

  Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak Pressure".

  Intraoperative from 1 minute after insertion of the device as a baseline to 60 minutes after insertion of the device

Secondary Outcomes (2)

• Ventilation score (grade 0, 1, 2 or 3),

  Intraoperative from 1 minute after insertion of the device as baseline to 60 minutes after insertion of the device

• Fiberoptic glottic view Score

  Intraoperative from 1 minute after insertion of the device to 60 minutes after insertion of the device.

Study Arms (2)

Moderate lateral Group

Patients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in moderate lateral position.

Device: AuraGain

Extreme lateral Group

Patients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in extreme lateral position.

Device: AuraGain

Interventions

AuraGain DEVICE

Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body.

Extreme lateral Group; Moderate lateral Group

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

\- children scheduled for elective outpatient surgery in which airway management with a® AuraGain would be appropriate.

You may qualify if:

• Weight: 15-30 kg.
• Age: 2-9 years.
• Sex: both males and females.
• ASA physical status: 1-3.
• Operation: elective outpatient surgery in which airway management with a® AuraGain would be appropriate.

You may not qualify if:

• Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
• Potentially difficult airway.
• Patients with history of neck, respiratory, or digestive tract pathology.
• Patients with gastroesophageal reflux, gastrointestinal stenosis, or stricture.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Hala Abdel-Ghaffar

Asyut, Asyut Governorate, 71515, Egypt

Location

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: November 3, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 29, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)