Respiration and The Airway With Supraglottic Airway Devices

NCT ID: NCT03384056

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-11-01

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.

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.

Conditions

Laryngeal Masks Comparison

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Self Pressurized Airway Device with Blocker

Self Pressurized Airway Device with Blocker

Intervention Type: DEVICE

used in adult low risk females undergoing elective gynecological operations

Proseal Laryngeal Mask Airway

Proseal Laryngeal Mask Airway

Intervention Type: DEVICE

used in adult low risk females undergoing elective gynecological operations.

Interventions

Self Pressurized Airway Device with Blocker

used in adult low risk females undergoing elective gynecological operations

Intervention Type: DEVICE

Proseal Laryngeal Mask Airway

used in adult low risk females undergoing elective gynecological operations.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Reham Ali Abdelhaleem Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Reham Ali Abdelhaleem Abdelrahman

Anaesthesia Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AR-1974

Identifier Type: -

Identifier Source: org_study_id