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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03002857
Other study ID # LMA-Urological surgery
Secondary ID
Status Completed
Phase N/A
First received December 17, 2016
Last updated May 6, 2017
Start date September 2015
Est. completion date September 2016

Study information

Verified date May 2017
Source Adiyaman University Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The most used airway management strategies are different types of supraglottic airway devices (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery . Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of this study was to evaluate and compare the performance of a new type of SAD the Baska Mask® with I-gel and LMA-C regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures in urological surgery as well.


Description:

The most used airway management strategies are different types of supraglottic airway devices (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery . Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of this study was to evaluate and compare the performance of a new type of SAD the Baska Mask® with I-gel and LMA-C regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures in urological surgery as well.

The main suggestion about the Baska Mask® is that it's the most appropriate airway device with high Paws. In high Paws, higher air leaks may occur from the sides of cuff and this causes hypoventilation. So the main aim of this study is to evaltuate three devices in terms of insertion and ventilation times, the "first attempt" success rates, the additional maneuvering requirements and complications developed after intervention.

The secondary objective of the study was to evaluate all three SADs in terms of airway pressures producing sufficient tidal volume and hemodynamical parameters.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- (ASA) 1-2-3 physical status scheduled for elective surgical procedure for transurethral resection of bladder and ureteroscopy.

Exclusion Criteria:

- Under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) > 30 kg m-2, ASA physical status 4 or over and patients who met the difficult intubation criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
LMA-C
LMA-C will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.
Baska Mask
Baska Mask will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.
I-gel
I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Adiyaman University Research Hospital Turkiye Yuksek Ihtisas Education and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Insertion times It was evaluated that how many secs does it take to insert properly. Perioperative
Primary Ventilation times It was evaluated that how many secs does it take to ventilate the patient. Perioperative
Primary First attemp success rates In how many patients it was inserted at first attempt Perioperative
Primary The additional maneuvering it was evaluated how many maneuvers needed to insert the device. Perioperative
Primary Airway related complications Complications like Bloodstain of the mask, Dysphagia, Tongue injury, Lips injury, Teeth injury, Palate injury, Sore throat, Hoarseness, Desaturation , Laryngospasm, Regurgitation/aspiration were evaluated. Perioperative
Secondary Airway PAP and Plateau pressures Both pressures were evaluated following device insertion and then in every 10 mins. Perioperative
Secondary Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg Preoperative and following device insertion all haemodynamic parameters were evaluated in every 10 mins. Perioperative
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