Respiration and The Airway With Supraglottic Airway Devices

Laryngeal Masks Comparison Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384056
• Other study ID #: AR-1974
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 1, 2019
• Est. primary completion date: October 1, 2019
• 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 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.

Related Conditions & MeSH terms

• Laryngeal Masks Comparison

Intervention

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

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	airway seal pressure	pressure at which leak starts to occur	one year
Primary	fitting of the device against larynx	detected by the flexible fiberoptic	one year
Secondary	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