Ventilation With Supraglottic Airway Devices

Laryngeal Masks Comparison Clinical Trial

Official title:

Evaluation of Performance of Air-Q Self Pressurized Airway Device With Blocker and Proseal Laryngeal Mask Airway at Different Head and Neck Positions in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421261
• Other study ID #: KR-1990
• Status: Completed
• Start date: June 4, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Adult female patients ASA I&II.

• age: 18-55 years old.

• BMI< 35.

• undergoing elective surgeries.

Exclusion Criteria:

• Patients with history of upper respiratory tract infections and obstructive sleep apnea.

• Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation &heart burn, those with esophageal reflux or hiatus hernia.

• Patients with coagulation disorders.

• Patients with El-Ganzouri airway score = 5 will.

Related Conditions & MeSH terms

• Laryngeal Masks Comparison

Intervention

Device:
• Air-Q Self Pressurized Airway Device with Blocker
used in low risk adult females undergoing elective surgeries
• Proseal Laryngeal Mask Airway
used in low risk adult female patients undergoing elective surgeries

Locations

Country	Name	City	State
Egypt	Department of anesthesia, Surgical ICU and Pain Management	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Reham Ali Abdelhaleem Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oropharyngeal leak pressure	pressure at which air leak starts to occur	1 year