Self-pressurized Air-Q With Blocker and Air-Q Blocker in Low Risk Female Patients Undergoing Ambulatory Surgery

NCT03816969 | Completed DMC

• 1 other identifier: N 1- 2018/Ms
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study investigators shall compare between the two types of air-Q 's; the Air-Q ILA blocker and the Air-Q SP with blocker , regarding good sealing and oropharyngeal leak pressure

Conditions

Ambulatory Surgery

Keywords

Self-pressurized Air Q

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure

  The Oropharyngeal leak pressure after insertion and fixation of the device

  10 Minutes after initial assessment

Secondary Outcomes (2)

• Insertion time

  10 Minutes

• Complications associated

  24 hours

Study Arms (2)

Self-pressurized air-Q with blocker

ACTIVE COMPARATOR

Self-pressurized air-Q with blocker has a greater seal pressure compared to Air-Q blocker, easier and faster in insertion and has less morbidity and complications while and after insertion

Device: Self-pressurized air-Q with blocker

Air-Q ILA blocker

ACTIVE COMPARATOR

It has a drain tube through which a suction tube is passed

Device: Air-Q ILA blocker

Interventions

Self-pressurized air-Q with blocker DEVICE

It has a drain tube through which a suction tube is passed like the Air-QILA blocker, and Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube , a communication orifice at the junction of the peri-glottic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation

Self-pressurized air-Q with blocker

Air-Q ILA blocker DEVICE

A good seal will provide good ventilation, will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation However, When the cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries

Air-Q ILA blocker

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients between the age group of 18 and 50 years.
• Patients of American Society of Anaesthesiologists (ASA) class I and II.
• Patients with Ganzouri airway score less than 4.

You may not qualify if:

• ASA III - V patients.
• Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.
• Patients with any oropharyngeal pathology.
• Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease, hiatus hernia or previous upper gastrointestinal tract surgery

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Officials

• Ahmed Abdalla Mohamed, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: It has a drain tube through which a suction tube is passed like the Air-QILA blocker, and Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube, a communication orifice at the junction of the peri-glottic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 25, 2019
• Study Start: January 5, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 18, 2019
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

EG (1)