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

NCT ID: NCT04649346

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-25

Study Completion Date

2021-07-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Oropharyngeal Leak Pressure

Keywords

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Supraglottic airway (SGA) devices

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SGA type 1

Observe the function of SGA type 1

No interventions assigned to this group

SGA type 2

Observe the function of SGA type 2

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liu Chih Min

Role: PRINCIPAL_INVESTIGATOR

visiting staff

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Liu Chih Min

Role: CONTACT

Phone: 02-23123456

Email: [email protected]

Facility Contacts

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Liu Chih Min

Role: primary

Other Identifiers

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201907019RINC

Identifier Type: -

Identifier Source: org_study_id