Gastric InsufflationNCT04964882
Gastric Insufflation During Positive Pressure Ventilation
A study testing ultrasound examination of air insufflation in the upper esophageal region and stomach in people with Gastric Insufflation, run by SMG-SNU Boramae Medical Center.
Trial summary
Effect of peak inspiratory pressure on the gastric insufflation is evaluated using ultrasonography during face mask ventilation in obese adults. Effect of facial mask holding techniques on the gastric insufflation is also evaluated. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Insufflation
- What is being tested?
- ultrasound examination of air insufflation in the upper esophageal region and stomach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2021to 5 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with body mass index ≥ 30 kg/m2 who are scheduled for general anesthesia
Who cannot join
- Risk of delayed gastric emptying or gastroesophageal reflux (gastroesophageal reflux disease, achalasia, history of stomach surgery, gastrointestinal obstruction, uncontrolled DM)
- Pregnancy
- Known or predicted difficult airway
About this study
Official title: Effect of the Peak Inspiratory Pressure and Facial Mask Holding Techniques on the Gastric Insufflation During Positive Pressure Ventilation With Facemask in Obese Adults
Effect of peak inspiratory pressure on the gastric insufflation is evaluated using ultrasonography during face mask ventilation in obese adults. Effect of facial mask holding techniques on the gastric insufflation is also evaluated.
- Conditions
- Gastric Insufflation
- Being tested
- ultrasound examination of air insufflation in the upper esophageal region and stomach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examination of air insufflation in the upper esophageal region and stomachDiagnostic test
Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation
| Study group | Role | What they receive |
|---|---|---|
| C-E Mask ventilation under PIP 10 cmH2O | Experimental | Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O. Receives: Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach |
| C-E Mask ventilation under PIP 15 cmH2O | Experimental | Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O. Receives: Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach |
| C-E Mask ventilation under PIP 20 cmH2O | Experimental | Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O. Receives: Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach |
| V-E Mask ventilation under PIP 10 cmH2O | Experimental | Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O. Receives: Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach |
| V-E Mask ventilation under PIP 15 cmH2O | Experimental | Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O. Receives: Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach |
| V-E Mask ventilation under PIP 20 cmH2O | Experimental | Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O. Receives: Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of gastric insufflation in the epigastric region
Under ultrasound, air signal is assessed in the epigastric region
Measured: During anesthesia induction
Secondary outcomes (3)
Cross-sectional area of the antral cross-sectional area
During ultrasound examination, anterior-posterior diameter and cranio-caudal diameter of the antrum are measured. Cross-sectional area of the gastric antrum is calculated as follows; (AP × CC × π)/4 (AP=antero-posterior diameter and CC=cranio-caudal diameter).
Measured: During anesthesia induction
Presence of gastric insufflation in the upper esophageal region
Under ultrasound, air signal is assessed in the upper esophageal region.
Measured: During anesthesia induction
Expiratory tidal volume
Expiratory tidal volumes displayed on the monitor of the anesthesia machine are recorded.
Measured: During anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start20 Jul 2021 (estimated)
- Primary completion5 Mar 2022 (estimated)
- Study completion5 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric InsufflationStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
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
- NCT04964882
- Sponsor's protocol ID
- 31-2021
- Status last verified
- Jul 2021
- First submitted
- 31 Mar 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Peak Inspiratory Pressure and Facial Mask Holding Techniques on the Gastric Insufflation During Positive Pressure Ventilation With Facemask in Obese Adults
- ClinicalTrials.gov ID
- NCT04964882
- Acronym / sponsor ID
- 31-2021
- Conditions
- Gastric Insufflation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 20 Jul 2021 (estimated)
- Primary completion
- 5 Mar 2022 (estimated)
- Study completion
- 5 Mar 2022 (estimated)
- First posted
- 16 Jul 2021 (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.
Effect of peak inspiratory pressure on the gastric insufflation is evaluated using ultrasonography during face mask ventilation in obese adults. Effect of facial mask holding techniques on the gastric insufflation is also evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C-E Mask ventilation under PIP 10 cmH2O | Experimental | Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomachTwo-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O. |
| C-E Mask ventilation under PIP 15 cmH2O | Experimental | Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomachTwo-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O. |
| C-E Mask ventilation under PIP 20 cmH2O | Experimental | Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomachTwo-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O. |
| V-E Mask ventilation under PIP 10 cmH2O | Experimental | Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomachTwo-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O. |
| V-E Mask ventilation under PIP 15 cmH2O | Experimental | Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomachTwo-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O. |
| V-E Mask ventilation under PIP 20 cmH2O | Experimental | Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomachTwo-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with body mass index ≥ 30 kg/m2 who are scheduled for general anesthesia
Key exclusion criteria (3 listed)
- Risk of delayed gastric emptying or gastroesophageal reflux (gastroesophageal reflux disease, achalasia, history of stomach surgery, gastrointestinal obstruction, uncontrolled DM)
- Pregnancy
- Known or predicted difficult airway
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 |
|---|---|---|
| ultrasound examination of air insufflation in the upper esophageal region and stomachPresence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation | Diagnostic test | C-E Mask ventilation under PIP 10 cmH2O, C-E Mask ventilation under PIP 15 cmH2O, C-E Mask ventilation under PIP 20 cmH2O, V-E Mask ventilation under PIP 10 cmH2O, V-E Mask ventilation under PIP 15 cmH2O, V-E Mask ventilation under PIP 20 cmH2O |
Primary outcome
Presence of gastric insufflation in the epigastric region
Time frame: During anesthesia induction
Under ultrasound, air signal is assessed in the epigastric region
3 secondary outcomes
Cross-sectional area of the antral cross-sectional area
Time frame: During anesthesia induction
Presence of gastric insufflation in the upper esophageal region
Time frame: During anesthesia induction
Expiratory tidal volume
Time frame: During anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound examination of air insufflation in the upper esophageal region and stomach in people with Gastric Insufflation, run by SMG-SNU Boramae Medical Center.
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: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Presence of gastric insufflation in the epigastric region (time frame: During anesthesia induction). 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 16 Jul 2021.