Ventilation With Supraglottic Airway Devices

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

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.

Study Overview

• Status: Completed
• Conditions: Laryngeal Masks Comparison
• Intervention / Treatment: Device: Air-Q Self Pressurized Airway Device with Blocker; Device: Proseal Laryngeal Mask Airway

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Department of anesthesia, Surgical ICU and Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adult female patients who will be admitted through outpatient clinic of Kasr alainy hospitals

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Proseal Laryngeal Mask Airway	Device: Proseal Laryngeal Mask Airway; used in low risk adult female patients undergoing elective surgeries
Air-Q Self Pressurized Airway Device with Blocker	Device: Air-Q Self Pressurized Airway Device with Blocker; used in low risk adult females undergoing elective surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oropharyngeal leak pressure	pressure at which air leak starts to occur	1 year

Collaborators and Investigators

• Sponsor: Reham Ali Abdelhaleem Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KR-1990

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No