The Difference of Oropharyngeal Leak Pressure and Sealing Pressure Between New Supraglottic Airway Devices

Oropharyngeal Leak Pressure Clinical Trial

— SGA  

Official title:

The Difference of Oropharyngeal Leak Pressure and Sealing Pressure Between New Supraglottic Airway Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649346
• Other study ID #: 201907019RINC
• Status: Recruiting
• Start date: March 25, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: Liu Chih Min
• Phone: 02-23123456
• Email: liu.chihmin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The difference of oropharyngeal leak pressure and sealing pressure between new supraglottic airway devices.

Description:

In this clinical study, investigators want to discuss the issue that oropharyngeal leak pressure and sealing condition with different SGA including air-Q、i-gel、LMA-supreme、AMBU auragain 、ProSeal LMA and other new SGAs.

In the perioperative period, investigators documented respiratory function data including oropharyngeal leak pressure and peak airway pressure in these randomly selected SGA. Oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and noting the airway pressure at which the dial on a calibrated aneroid manometer reached equilibrium.

investigators wanted to compared the respiratory function between air-Q、i-gel、LMA-supreme、AMBU auragain、ProSeal LMA and other new SGAs during surgery and postoperative care unit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria:

1. 20-80 years old.

2. ASA physical status I or II .

3. Without major organ dysfunction like heart, liver, brain, lung, kidney function failure.

Exclusion criteria:

1. BMI> 35 kg/m2.

2. Risk of aspiration(NPO clear water> 2 hours, solid foods > 8 hours).

3. Difficult airway like head and neck tumor or airway tumor.

4. Limited mouth opening (<2cm).

5. major organ dysfunction including heart, liver, brain, lung, kidney function failure.

6. Major surgery including open heart surgery, laparotomy general surgery, open chest surgery.

Related Conditions & MeSH terms

• Oropharyngeal Leak Pressure

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal leak pressures	oropharyngeal leak pressure units ( cmH2O )	10 minutes
Secondary	1. The participant's head and neck position 2. The number of attempts required for SGA insertion 3. Ease of gastric tube placement 4. The ventilation score	The participant's head and neck position (neutral/extension/flexion/rotation); The number of attempts required for SGA insertion (1/2/3/tracheal intubation); Ease of gastric tube placement (success/failure/Leak); The ventilation score was scored from 0 to 3 based on three criteria: (1) No leakage with an airway pressure of > 15 cm H2O (2) Bilateral chest excursions with a peak inspiratory pressure of > 20 cm H2O (3) A Square Wave Capnography with each item scoring 0 or 1 point. Thus, if all three criteria were satisfied, the ventilation score was 3.	180 minutes