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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04021407
Other study ID # LMA versus Air Q
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date June 1, 2019

Study information

Verified date July 2019
Source Menoufia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
LMA group
patients were ventilated with LMA
AirQ group
patients were ventilated with AirQ airway

Locations

Country Name City State
Egypt Ashraf Eskandr Shibin Al Kawm Menoufiya

Sponsors (1)

Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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