Mechanical VentilationNCT03241654
Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Ventilation Distribution
An observational study of Mechanical Ventilation, run by Capital Medical University at 1 site in China.
Trial summary
In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region.Decrease of flow trigger sensitivity might improve homogeneous of tidal volume distribution. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- flow trigger
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Feb 2018
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The postoperative patients receiving pressure support ventilation and existing heterogenous ventilation.
Who may be able to join
- The post operative patients who received pressure support ventilation;
- After the clinical PEEP was evaluated 5cmH2O, the tidal volume distribution still existed heterogeneity.
Who cannot join
- Under 18 years;
- History of diaphragm dysfunction and surgery;
- Central respiratory drive dysfunction;
- history of esophageal, gastric or lung surgery;
- The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Aeration and Homogeneity During Pressure Assist Ventilation: A Preliminarily Physiological Study
In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region.Decrease of flow trigger sensitivity might improve homogeneous of tidal volume distribution.
Read the detailed description
In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region. High positive end expiratory pressure (PEEP) has been applied to improve the homogeneous distribution of ventilation by increasing the end expiratory lung ventilation (EELV) and alveolar recruitment. However, for patients who increasing PEEP in some extent still existed poor aeration in the dependent region, further elevating PEEP seems to be unreasonable that perhaps lead to overdistension. Decreasing trigger sensitivity might further evoke inspiratory efforts to improve the ventilation for this type of patients.The Electrical impedance tomography (EIT) was applied in monitoring the regional ventilation distribution at the bedside.
- Conditions
- Mechanical Ventilation
- Being tested
- flow trigger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow triggerProcedure or surgery
The flow trigger will be adjust during the pressure assist ventilation.
| Study group | Role | What they receive |
|---|---|---|
| the lowest trigger sensitivity | The flow trigger of ventilator was set as the lowest level of sensitivity. Receives: Procedure: flow trigger | |
| the highest trigger sensitivity | The flow trigger of ventilator was set as the highest level of sensitivity. Receives: Procedure: flow trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
The homogeneity of distribution of tidal volume
EIT was used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.
Measured: within 20 minutes after changing flow trigger
Secondary outcomes (1)
Changes in global and regional EELV
The change of EELV was measured after changing flow trigger based on the baseline level.
Measured: within 20 minutes after changing flow trigger
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 May 2017
- Primary completion20 Aug 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241654
- Sponsor's protocol ID
- KY-2017-001
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2017
- Last updated
- 12 Feb 2018
- 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 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Aeration and Homogeneity During Pressure Assist Ventilation: A Preliminarily Physiological Study
- ClinicalTrials.gov ID
- NCT03241654
- Acronym / sponsor ID
- KY-2017-001
- Conditions
- Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 20 Aug 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 7 Aug 2017 (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.
In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region.Decrease of flow trigger sensitivity might improve homogeneous of tidal volume distribution.
Detailed description
In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region. High positive end expiratory pressure (PEEP) has been applied to improve the homogeneous distribution of ventilation by increasing the end expiratory lung ventilation (EELV) and alveolar recruitment. However, for patients who increasing PEEP in some extent still existed poor aeration in the dependent region, further elevating PEEP seems to be unreasonable that perhaps lead to overdistension. Decreasing trigger sensitivity might further evoke inspiratory efforts to improve the ventilation for this type of patients.The Electrical impedance tomography (EIT) was applied in monitoring the regional ventilation distribution at the bedside.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the lowest trigger sensitivity | – | Procedure: flow triggerThe flow trigger of ventilator was set as the lowest level of sensitivity. |
| the highest trigger sensitivity | – | Procedure: flow triggerThe flow trigger of ventilator was set as the highest level of sensitivity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The postoperative patients receiving pressure support ventilation and existing heterogenous ventilation.
Key inclusion criteria (2 listed)
- The post operative patients who received pressure support ventilation;
- After the clinical PEEP was evaluated 5cmH2O, the tidal volume distribution still existed heterogeneity.
Key exclusion criteria (5 listed)
- Under 18 years;
- History of diaphragm dysfunction and surgery;
- Central respiratory drive dysfunction;
- history of esophageal, gastric or lung surgery;
- The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).
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 |
|---|---|---|
| flow triggerThe flow trigger will be adjust during the pressure assist ventilation. | Procedure or surgery | the highest trigger sensitivity, the lowest trigger sensitivity |
Primary outcome
The homogeneity of distribution of tidal volume
Time frame: within 20 minutes after changing flow trigger
EIT was used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.
1 secondary outcome
Changes in global and regional EELV
Time frame: within 20 minutes after changing flow trigger
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 12 Feb 2018.
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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.
Jian-Xin Zhou, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Capital Medical University at 1 site in China.
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 5 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 12 Feb 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 China. 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?
The homogeneity of distribution of tidal volume (time frame: within 20 minutes after changing flow trigger). 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 12 Feb 2018.