Respiration and The Airway With Supraglottic Airway Devices

NCT03384056 | Completed DMC

• 1 other identifier: AR-1974
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laryngeal Masks Comparison

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• insertion time of the device

  one year

Study Arms (2)

Self Pressurized Airway Device with Blocker

Device: Self Pressurized Airway Device with Blocker

Proseal Laryngeal Mask Airway

Device: Proseal Laryngeal Mask Airway

Interventions

Self Pressurized Airway Device with Blocker DEVICE

used in adult low risk females undergoing elective gynecological operations

Self Pressurized Airway Device with Blocker

Proseal Laryngeal Mask Airway DEVICE

used in adult low risk females undergoing elective gynecological operations.

Proseal Laryngeal Mask Airway

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

adult female patients undergoing elective gynecological operations.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reham Ali Abdelhaleem Abdelrahman: lead

Study Sites (1)

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anaesthesia Lecturer

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 27, 2017
• Study Start: February 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

EG (1)