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Completed

NCT Number: NCT03816969

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

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 10 Minutes after initial assessment

    The Oropharyngeal leak pressure after insertion and fixation of the device

Secondary outcomes

  1. Insertion time

    Time frame: 10 Minutes

    time of insertion

  2. Complications associated

    Time frame: 24 hours

    Hypoxemia (SpO2 <90%), intra and postoperative

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2019
Registry last updated
Jul 26, 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.

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