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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04649346

Acronym

SGA

Enrollment

Registered

2020-12-02

Start date

2020-03-25

Completion date

2021-07-30

Last updated

2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Leak Pressure

Keywords

Supraglottic airway (SGA) devices

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Taiwan

Contacts

Primary ContactLiu Chih Min

liu.chihmin@gmail.com02-23123456

Outcome results