Oropharyngeal Leak PressureSGANCT04649346
The Difference of Oropharyngeal Leak Pressure and Sealing Pressure Between New Supraglottic Airway Devices
An observational study of Oropharyngeal Leak Pressure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The difference of oropharyngeal leak pressure and sealing pressure between new supraglottic airway devices. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Oropharyngeal Leak Pressure
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Mar 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All general anesthesia patients who use SGA.
Who may be able to join
- 20-80 years old.
- ASA physical status I or II .
- Without major organ dysfunction like heart, liver, brain, lung, kidney function failure.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Liu Chih Min, 02-23123456 ext. 62158, 52224, liu.chihmin@gmail.com
About this study
The difference of oropharyngeal leak pressure and sealing pressure between new supraglottic airway devices.
Read the 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.
- Conditions
- Oropharyngeal Leak Pressure
- Keywords
- Supraglottic airway (SGA) devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SGA type 1 | Observe the function of SGA type 1 | |
| SGA type 2 | Observe the function of SGA type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressures
oropharyngeal leak pressure units ( cmH2O )
Measured: 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
- 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.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start25 Mar 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Leak PressureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Chih Min, Principal investigator, visiting staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649346
- Sponsor's protocol ID
- 201907019RINC
- Acronym
- SGA
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Oropharyngeal Leak Pressure and Sealing Pressure Between New Supraglottic Airway Devices
- ClinicalTrials.gov ID
- NCT04649346
- Acronym / sponsor ID
- SGA / 201907019RINC
- Conditions
- Oropharyngeal Leak Pressure
- Keywords
- Supraglottic airway (SGA) devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGA type 1 | – | –Observe the function of SGA type 1 |
| SGA type 2 | – | –Observe the function of SGA type 2 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All general anesthesia patients who use SGA.
Key inclusion criteria (3 listed)
- 20-80 years old.
- ASA physical status I or II .
- Without major organ dysfunction like heart, liver, brain, lung, kidney function failure.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oropharyngeal leak pressures
Time frame: 10 minutes
oropharyngeal leak pressure units ( cmH2O )
1 secondary outcome
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
Time frame: 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
Related trials for Oropharyngeal Leak Pressure
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Not yet recruitingObservational study
Effects of Video LMA Cuff Pressure in Tympanoplasty.
Oropharyngeal Leak Pressure, Airway Management
Active, not recruiting
Comparison of Oropharyngeal Leak Pressures of SaCo Video Laryngeal Mask Airway (LMA) and ProSeal LMA in Adult Elective Surgery
Oropharengeal Leak Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Chih Min principal investigator
visiting staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Leak Pressure, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Chih Min (02-23123456 ext. 62158, 52224, liu.chihmin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal leak pressures (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.