Respiration and The Airway With Supraglottic Airway Devices

Comparison of Air-Q Self Pressurized Airway Device With Blocker With Proseal Laryngeal Mask Airway in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations

The investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological operations. The investigators aim at assessment of fitting of both devices against the glottic region that detected by the flexible fiberoptic bronchoscope( Pentex Corporation, Medical Division, Singapore)and assessment of any associated postoperative complications.

Hypothesis:

The investigators hypothesize that the self-pressurized air-Q with blocker has a greater seal pressure compared to Proseal, easier and faster in insertion with less morbidity and complications during and after its insertion.

Study Overview

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

Detailed Description

The study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. The study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. The investigators will recruit 150 adult female(18-55 years old, ASAI&II) patients to a prospective randomized comparative controlled two-arm parallel clinical trial. Patients with history of upper respiratory tract infections, obstructive sleep apnea, potentially full stomach (trauma, morbid obesity BMI> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. All patients will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study. The patients will be randomly allocated into two groups(the SP-Blocker group & the P-LMA group; each group is 75 patients) using computer generated program . An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.

• Study Type: Observational
• Enrollment (Actual): 150

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
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

adult female patients undergoing elective gynecological operations.

Description

Inclusion Criteria:

• Adult female patients ASA I&II
• Age: 18- 55 years old
• BMI < 35
• Undergoing elective gynecological operations.

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
Self Pressurized Airway Device with Blocker	Device: Self Pressurized Airway Device with Blocker; used in adult low risk females undergoing elective gynecological operations
Proseal Laryngeal Mask Airway	Device: Proseal Laryngeal Mask Airway; used in adult low risk females undergoing elective gynecological operations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway seal pressure	pressure at which leak starts to occur	one year
fitting of the device against larynx	detected by the flexible fiberoptic	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion time of the device	is defined as time in seconds from the chosen device touching the teeth to the first recorded near rectangular capnogram curve in the presence of satisfactory bilateral chest expansion.	one year

Collaborators and Investigators

• Sponsor: Reham Ali Abdelhaleem Abdelrahman

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (ACTUAL): December 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AR-1974

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes