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

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

Study Overview

• Status: Unknown
• Conditions: Oropharyngeal Leak Pressure

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Liu Chih Min; Phone Number: 62158, 52224 02-23123456; Email: liu.chihmin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All general anesthesia patients who use SGA.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
SGA type 1; Observe the function of SGA type 1
SGA type 2; Observe the function of SGA type 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressures	oropharyngeal leak pressure units ( cmH2O )	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Liu Chih Min, visiting staff

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Supraglottic airway (SGA) devices
• Other Study ID Numbers: 201907019RINC