VentilationNCT03996161
Effect of Semi-sitting Position on Mask Ventilation
A study testing patient position in people with Ventilation, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ventilation
- What is being tested?
- patient position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2020to 8 Jun 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients undergoing general anesthesia
Who cannot join
- diseases or structural abnormalities in the upper airway
- those who were at risk of aspiration
- cardiovascular or respiratory diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Semi-sitting Position on Mask Ventilation in Anesthetized and Paralyzed Patients
We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients
- Conditions
- Ventilation
- Being tested
- patient position
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient positionOther
After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Active comparator | After the induction of anesthesia, mask ventilation is performed in the supine position. Receives: Other: patient position |
| Semi-sitting position | Experimental | After the induction of anesthesia, mask ventilation is performed in the semi-sitting position. Receives: Other: patient position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory tidal volume
Expiratory tidal volume is assessed during mask ventilation in the supine and semi-sitting positions.
Measured: 1 minute after the induction of anesthesia
Secondary outcomes (3)
Minute ventilation during mask ventilation in the supine and semi-sitting positions
Minute ventilation is assessed during mask ventilation
Measured: 1 minute after anesthesia induction
The incidence of inadequate mask ventilation or dead space ventilation.
The incidence of inadequate mask ventilation or dead space ventilation is recorded.
Measured: during mask ventilation
Peak inspiratory pressure
Peak inspiratory pressure is recorded.
Measured: during mask ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start9 Mar 2020
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 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
- NCT03996161
- Sponsor's protocol ID
- 2019-1231
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang JE, Seol T, Hwang JY. Body position and the effectiveness of mask ventilation in anaesthetised paralysed obese patients: A randomised cross-over study. Eur J Anaesthesiol. 2021 Aug 1;38(8):825-830. doi: 10.1097/EJA.0000000000001473.
PubMed 33600105
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semi-sitting Position on Mask Ventilation in Anesthetized and Paralyzed Patients
- ClinicalTrials.gov ID
- NCT03996161
- Acronym / sponsor ID
- 2019-1231
- Conditions
- Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 24 Jun 2019 (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.
We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine position | Active comparator | Other: patient positionAfter the induction of anesthesia, mask ventilation is performed in the supine position. |
| Semi-sitting position | Experimental | Other: patient positionAfter the induction of anesthesia, mask ventilation is performed in the semi-sitting position. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese patients undergoing general anesthesia
Key exclusion criteria (4 listed)
- diseases or structural abnormalities in the upper airway
- those who were at risk of aspiration
- cardiovascular or respiratory diseases
- pregnancy
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 |
|---|---|---|
| patient positionAfter the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order. | Other | Semi-sitting position, Supine position |
Primary outcome
Expiratory tidal volume
Time frame: 1 minute after the induction of anesthesia
Expiratory tidal volume is assessed during mask ventilation in the supine and semi-sitting positions.
3 secondary outcomes
Minute ventilation during mask ventilation in the supine and semi-sitting positions
Time frame: 1 minute after anesthesia induction
The incidence of inadequate mask ventilation or dead space ventilation.
Time frame: during mask ventilation
Peak inspiratory pressure
Time frame: during mask ventilation
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 11 Jun 2020.
- Derived from this study: PubMed 33600105Chang JE, Seol T, Hwang JY. Body position and the effectiveness of mask ventilation in anaesthetised paralysed obese patients: A randomised cross-over study. Eur J Anaesthesiol. 2021 Aug 1;38(8):825-830. doi: 10.1097/EJA.0000000000001473.
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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 patient position 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 4 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 11 Jun 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 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: 1 minute 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 NCT03996161, 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 11 Jun 2020.