NCT04649346

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

December 2, 2020

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

October 7, 2020

Last Update Submit

November 24, 2020

Conditions

Oropharyngeal Leak Pressure

Keywords

Supraglottic airway (SGA) devices

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressures

    oropharyngeal leak pressure units ( cmH2O )

    10 minutes

Secondary Outcomes (1)

  • 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

Study Arms (2)

SGA type 1

Observe the function of SGA type 1

SGA type 2

Observe the function of SGA type 2

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All general anesthesia patients who use SGA.

You may qualify if:

  • years old.
  • ASA physical status I or II .
  • Without major organ dysfunction like heart, liver, brain, lung, kidney function failure.

You may not qualify if:

  • BMI\> 35 kg/m2.
  • Risk of aspiration(NPO clear water\> 2 hours, solid foods \> 8 hours).
  • Difficult airway like head and neck tumor or airway tumor.
  • Limited mouth opening (\<2cm).
  • major organ dysfunction including heart, liver, brain, lung, kidney function failure.
  • Major surgery including open heart surgery, laparotomy general surgery, open chest surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Liu Chih Min

    visiting staff

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Chih Min

CONTACT

02-23123456liu.chihmin@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

December 2, 2020

Study Start

March 25, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

December 2, 2020

Record last verified: 2020-10

Locations

TW(1)