VentilationNCT02751047
Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children
A study testing manual ventilation in people with Ventilation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation. Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation
- What is being tested?
- manual ventilation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to Jan 2017
- 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 month to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with American Society of Anesthesiologist (ASA) physical status 1, 2
- Children with normal body mass index
Who cannot join
- Difficult airway management
- pulmonary disease
- upper respiratory infection
- risk of pulmonary aspiration
- intestinal obstruction or abdominal distension
- stroke history or moyamoya disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children
The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.
- Conditions
- Ventilation
- Being tested
- manual ventilation, Pressure controlled mechanical 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.
manual ventilationOther
Facemask ventilation is performed by manual bagging with reservoir bag.
Pressure controlled mechanical ventilationOther
Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.
| Study group | Role | What they receive |
|---|---|---|
| Manual ventilation | Placebo comparator | During anesthetic induction, facemask ventilation is performed by manual bagging, after setting adjustable pressure limiting (APL) valve at 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation. Receives: Other: manual ventilation |
| Pressure controlled mechanical ventilation | Active comparator | During anesthetic induction, facemask ventilation is performed with mechanical ventilator by pressure controlled mode, with inspiratory pressure of 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation. Receives: Other: Pressure controlled mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastric insufflation
Measured: During facemask ventilation (90 seconds)
Secondary outcomes (1)
The number of patients with adequate tidal volume
Tidal volume of 6 - 10 ml/kg
Measured: During facemask ventilation (90 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751047
- Sponsor's protocol ID
- H1602-094-741
- Status last verified
- Aug 2018
- First submitted
- 22 Apr 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children
- ClinicalTrials.gov ID
- NCT02751047
- Acronym / sponsor ID
- H1602-094-741
- Conditions
- Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Apr 2016 (estimated)
- 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 investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual ventilation | Placebo comparator | Other: manual ventilationDuring anesthetic induction, facemask ventilation is performed by manual bagging, after setting adjustable pressure limiting (APL) valve at 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation. |
| Pressure controlled mechanical ventilation | Active comparator | Other: Pressure controlled mechanical ventilationDuring anesthetic induction, facemask ventilation is performed with mechanical ventilator by pressure controlled mode, with inspiratory pressure of 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with American Society of Anesthesiologist (ASA) physical status 1, 2
- Children with normal body mass index
Key exclusion criteria (6 listed)
- Difficult airway management
- pulmonary disease
- upper respiratory infection
- risk of pulmonary aspiration
- intestinal obstruction or abdominal distension
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 |
|---|---|---|
| manual ventilationFacemask ventilation is performed by manual bagging with reservoir bag. | Other | Manual ventilation |
| Pressure controlled mechanical ventilationFacemask ventilation is performed with mechanical ventilator by pressure controlled mode. | Other | Pressure controlled mechanical ventilation |
Primary outcome
Incidence of gastric insufflation
Time frame: During facemask ventilation (90 seconds)
1 secondary outcome
The number of patients with adequate tidal volume
Time frame: During facemask ventilation (90 seconds)
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 22 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
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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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual ventilation in people with Ventilation, run by Seoul National University Hospital 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 2 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: finished, as of the sponsor's last update on 22 Aug 2018. 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. 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?
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?
Incidence of gastric insufflation (time frame: During facemask ventilation (90 seconds)). 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 22 Aug 2018.