Ventilator LungNCT03881033
Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography
A study testing Peep 5cmH2O and Peak inspiratory pressure in people with Ventilator Lung and Ultrasound, run by Ajou University School of Medicine.
Trial summary
The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Ventilator Lung, Ultrasound
- What is being tested?
- Peep 5cmH2O and Peak inspiratory pressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 30 Nov 2019
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The ASA class I,II and 1-5 years pediatric patients need general anesthesia
Who cannot join
- Oropharyngeal or facial pathology accompanied
- Obese (BMI > 30 kg/m2)
- GI tract obstruction
About this study
The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.
The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.
- Conditions
- Ventilator Lung, Ultrasound
- Being tested
- Peep 5cmH2O, Peak inspiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peep 5cmH2OOther
Also called Peak inspiratory pressure
Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.
Peak inspiratory pressureOther
Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.
| Study group | Role | What they receive |
|---|---|---|
| P12 | Placebo comparator | Not described Receives: Other: Peak inspiratory pressure |
| P7+5 | Active comparator | Not described Receives: Other: Peep 5cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of atelectasis
After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.
Measured: 1min after ventilator-on
Secondary outcomes (1)
The incidence of gastric insufflation
Measured: During face mask ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator LungStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Yoo, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881033
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-192
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 19 Mar 2019
- 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 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography
- ClinicalTrials.gov ID
- NCT03881033
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-192
- Conditions
- Ventilator Lung, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 19 Mar 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.
The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.
The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P12 | Placebo comparator | Other: Peak inspiratory pressure |
| P7+5 | Active comparator | Other: Peep 5cmH2O |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The ASA class I,II and 1-5 years pediatric patients need general anesthesia
Key exclusion criteria (3 listed)
- Oropharyngeal or facial pathology accompanied
- Obese (BMI > 30 kg/m2)
- GI tract obstruction
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 |
|---|---|---|
| Peep 5cmH2OAlso: Peak inspiratory pressureFace mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O. | Other | P7+5 |
| Peak inspiratory pressureFace mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP. | Other | P12 |
Primary outcome
The degree of atelectasis
Time frame: 1min after ventilator-on
After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.
1 secondary outcome
The incidence of gastric insufflation
Time frame: During face mask ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Related trials for Ventilator Lung
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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 Peep 5cmH2O and Peak inspiratory pressure in people with Ventilator Lung and Ultrasound, run by Ajou University School of Medicine.
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 19 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
The degree of atelectasis (time frame: 1min after ventilator-on). 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 19 Mar 2019.