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

• ClinicalTrials.gov Identifier: NCT03816969
• Recruitment Status: Completed
• First Posted: January 25, 2019
• Last Update Posted: July 26, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Abdalla, Cairo University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Ambulatory Surgery	Device: Self-pressurized air-Q with blocker; Device: Air-Q ILA blocker	Not Applicable

Detailed Description:

The Air-Q family has introduced many improved designs, among which the Air- Q blocker intubating laryngeal airway (Air-Q ILA blocker) in 2011. It has all the previously mentioned advantages, and in addition, a new, built-in, soft guide channel that accepts regular Nasal Gastric (NG) tubes to suction or optional Blocker Tubes for accessing the posterior pharynx and managing the esophagus. investigators can suction the pharynx or suction, vent and block the upper esophagus. Ever since the idea of SAD has launched and applying an optimum intra-cuff pressure that maintains enough sealing and at the same time not injurious to the oropharyngeal mucosa concerns anesthesiologists 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 Therefore, in 2013 another improvised design of the Air-Q family has evolved, a Self-pressurized Air Q (air-Q SP) with blocker) . 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. 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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Double (Participant, Investigator)
• Masking Description: 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.
• Primary Purpose: Supportive Care
• Official Title: A Prospective Randomized Comparative Study Between the Self-pressurized Air-Q With Blocker and Air-Q Blocker in Low Risk Female Patients Undergoing Ambulatory Surgery
• Actual Study Start Date: January 5, 2018
• Actual Primary Completion Date: January 10, 2019
• Actual Study Completion Date: January 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Self-pressurized air-Q with blocker; 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; 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
Active Comparator: Air-Q ILA blocker; It has a drain tube through which a suction tube is passed	Device: Air-Q ILA blocker; 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

Outcome Measures

Primary Outcome Measures :

1. Oropharyngeal leak pressure [ Time Frame: 10 Minutes after initial assessment ]
   The Oropharyngeal leak pressure after insertion and fixation of the device

Secondary Outcome Measures :

1. Insertion time [ Time Frame: 10 Minutes ]
   time of insertion
2. Complications associated [ Time Frame: 24 hours ]
   Hypoxemia (SpO2 <90%), intra and postoperative

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Egypt

Ahmed Abdalla Mohamed

Cairo, Egypt, 11451

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Ahmed Abdalla Mohamed, M.D; Cairo University

More Information

• Responsible Party: Ahmed Abdalla, Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University, Cairo University
• ClinicalTrials.gov Identifier: NCT03816969
• Other Study ID Numbers: N 1- 2018/Ms
• First Posted: January 25, 2019
• Last Update Posted: July 26, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Till Press

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmed Abdalla, Cairo University:

Self-pressurized Air Q