Skip to main content
OpenTrials
Completed

NCT Number: NCT03384056

Respiration and The Airway With Supraglottic Airway Devices

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self Pressurized Airway Device with Blocker

Device

used in adult low risk females undergoing elective gynecological operations

ProSeal Laryngeal mask airway

Device

used in adult low risk females undergoing elective gynecological operations.

Primary outcomes

  1. airway seal pressure

    Time frame: one year

    pressure at which leak starts to occur

  2. fitting of the device against larynx

    Time frame: one year

    detected by the flexible fiberoptic

Secondary outcomes

  1. insertion time of the device

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Reham Ali Abdelhaleem Abdelrahman

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2017
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.