Laryngeal Mask Airway Versus Air Q Laryngeal Airway

Laryngeal Mask Airway Versus Air Q Laryngeal Airway in Dacryocystorhinostomy

Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices that can be used to maintain and protect airways from aspiration of secretions and blood during DCR surgery. The present study was designed to compare standard LMA versus air Q as regards the sealing effect and aspiration of blood in DCR surgery.

Study Overview

• Status: Completed
• Conditions: Airway Devices
• Intervention / Treatment: Device: LMA group; Device: AirQ group

Detailed Description

72 patients were divided into two groups, 36 patients each, named LMA group, and air Q group according to supraglottic devices used. The following parameters were recorded in both studied groups, continuous Electrocardiography (ECG), heart rate (HR), means arterial pressure (MAP), arterial oxygen saturation (SpO2), end tidal carbon di-oxide (PCO2)..Oro pharyngeal leak pressure in (cmH2O), exhaled tidal volume in (ml), leak volume in (ml), leak fraction in (%) number of shifting from LMA to air Q or ETT and shifting from air Q to LMA or ETT was recorded with absence or presence of surgical blood on The undersurface of the device used.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufiya
    • Shibīn Al Kawm, Menoufiya, Egypt, 1234
      • Ashraf Eskandr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both sex
• Age: 18-60 years
• ASA I-II
• Patients scheduled for dacryocystorhinostomy surgery

Exclusion Criteria:

• Any pathology of the neck, upper respiratory tract, upper alimentary tract
• Patients with a history of gastric regurgitation, heartburn
• Morbid obese,
• Patients with esophageal reflux (hiatus hernia)
• Anticipating difficult airway management
• Patients with coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: LMA; 36 patients were ventilated with LMA during dacryocystorhinostomy surgery	Device: LMA group; patients were ventilated with LMA
ACTIVE_COMPARATOR: AirQ; 36 patients each were ventilated with air Q airway during dacryocystorhinostomy surgery	Device: AirQ group; patients were ventilated with AirQ airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oro pharyngeal leak pressure in (cmH2O)	By setting the pop-off valve to limit peak airway pressure to 40 cm H2O and allowing airway pressure to increase at a fresh gas flow of 3 L/min until audible noise was heard over the mouth and no further increase in airway pressure is observed.	Just after insertion of supraglottic airway devices

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak fraction in (%)	Leak fraction in (%)( Leak was calculated by subtracting the expiratory volume from the inspiratory volume and expressed as a fraction of the inspiratory volume). were evaluated just before surgery	Just after insertion of supraglottic airway devices

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: LMA; AirQ; dacrocystorhinostomy surgery
• Other Study ID Numbers: LMA versus Air Q

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No