VentilationNCT05388266
Effect of Paratracheal Pressure on Mask Ventilation
A study testing Mask ventilation in people with Ventilation, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
This study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ventilation
- What is being tested?
- Mask ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jul 2022to 20 Oct 2022
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery
Who cannot join
- Structural abnormalities or diseases in the face, neck, upper airway, or esophagus
- Increased risk of aspiration (pregnancy)
- Carotid artery stenosis, cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: Effect of Paratracheal Pressure on Mask Ventilation in Anesthetized Obese Patients
This study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure.
- Conditions
- Ventilation
- Being tested
- Mask ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mask ventilationOther
Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.
| Study group | Role | What they receive |
|---|---|---|
| Paratracheal pressure | Experimental | After the induction of anesthesia, paratracheal pressure is applied during mask ventilation. Receives: Other: Mask ventilation |
| No pressure | Active comparator | After the induction of anesthesia, no pressure is applied during mask ventilation. Receives: Other: Mask ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory tidal volume
Volume controlled mechanical ventilation is delivered during mask ventilation. Expiratory tidal volumes on the monitor screen are recorded during mask ventilation
Measured: For 2 min of mask ventilation after the induction of anesthesia
Secondary outcomes (3)
Peak inspiratory pressure
Peak inspiratory pressure on the screen is recorded during mask ventilation.
Measured: For 2 min of mask ventilation after the induction of anesthesia
Inadequate tidal volume
Incidence of tidal volume less than 150 mL is recorded.
Measured: For 2 min of mask ventilation after the induction of anesthesia
Incidence of hypoxia
Occurrence of hypoxia (SpO2 <90%) is recorded.
Measured: For 2 min of mask ventilation after the induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start4 Jul 2022
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VentilationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388266
- Sponsor's protocol ID
- 05112022
- Status last verified
- Oct 2022
- First submitted
- 12 May 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seol T, Kim H, Chang JE, Kang Y, Hwang JY. Effect of paratracheal pressure on the effectiveness of mask ventilation in obese anesthetized patients: a randomized, cross-over study. J Clin Monit Comput. 2024 Feb;38(1):31-36. doi: 10.1007/s10877-023-01048-8. Epub 2023 Jul 7.
PubMed 37418060
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paratracheal Pressure on Mask Ventilation in Anesthetized Obese Patients
- ClinicalTrials.gov ID
- NCT05388266
- Acronym / sponsor ID
- 05112022
- Conditions
- Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 24 May 2022 (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.
This study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paratracheal pressure | Experimental | Other: Mask ventilationAfter the induction of anesthesia, paratracheal pressure is applied during mask ventilation. |
| No pressure | Active comparator | Other: Mask ventilationAfter the induction of anesthesia, no pressure is applied during mask ventilation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery
Key exclusion criteria (3 listed)
- Structural abnormalities or diseases in the face, neck, upper airway, or esophagus
- Increased risk of aspiration (pregnancy)
- Carotid artery stenosis, cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mask ventilationMask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner. | Other | No pressure, Paratracheal pressure |
Primary outcome
Expiratory tidal volume
Time frame: For 2 min of mask ventilation after the induction of anesthesia
Volume controlled mechanical ventilation is delivered during mask ventilation. Expiratory tidal volumes on the monitor screen are recorded during mask ventilation
3 secondary outcomes
Peak inspiratory pressure
Time frame: For 2 min of mask ventilation after the induction of anesthesia
Inadequate tidal volume
Time frame: For 2 min of mask ventilation after the induction of anesthesia
Incidence of hypoxia
Time frame: For 2 min of mask ventilation after the induction of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 37418060Seol T, Kim H, Chang JE, Kang Y, Hwang JY. Effect of paratracheal pressure on the effectiveness of mask ventilation in obese anesthetized patients: a randomized, cross-over study. J Clin Monit Comput. 2024 Feb;38(1):31-36. doi: 10.1007/s10877-023-01048-8. Epub 2023 Jul 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask ventilation in people with Ventilation, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 1 Nov 2022. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory tidal volume (time frame: For 2 min of mask ventilation after the induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388266, which also lists 1 linked publication.
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 1 Nov 2022.