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

Ambulatory Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816969
• Other study ID #: N 1- 2018/Ms
• Status: Completed
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: January 18, 2019

Study information

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

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 18, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla Mohamed	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal leak pressure	The Oropharyngeal leak pressure after insertion and fixation of the device	10 Minutes after initial assessment
Secondary	Insertion time	time of insertion	10 Minutes
Secondary	Complications associated	Hypoxemia (SpO2 <90%), intra and postoperative	24 hours