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

• Conditions: Oropharyngeal Leak Pressure

• Registration Number: NCT04649346
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2020-03-25
• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-11-24
• Last Update Submitted: 2020-11-24
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressures	10 minutes	oropharyngeal leak pressure units ( cmH2O )

Secondary Outcome Measures

Name	Time	Method
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	180 minutes	1. The participant's head and neck position (neutral/extension/flexion/rotation); 2. The number of attempts required for SGA insertion (1/2/3/tracheal intubation); 3. Ease of gastric tube placement (success/failure/Leak); 4. 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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan