Mechanical VentilationNCT05026463
Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation
A study testing Inspiratory support level in people with Mechanical Ventilation, run by Capital Medical University at 2 sites in China.
Trial summary
Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. 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?
- Inspiratory support level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2021to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilated patients within 48 hours after the transition from a controlled mode to PSV
Who cannot join
- History of neuromuscular disease
- History of diaphragm dysfunction and surgery
- History of esophageal, gastric or lung surgery
- Decreased level of consciousness
- Central respiratory drive dysfunction
- Considered withholding of life support
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
De-Jing Song, BS
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Yan-Lin Yang, MD
About this study
Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.
- Conditions
- Mechanical Ventilation
- Being tested
- Inspiratory support level
- Keywords
- mechanical ventilation, pressure support, inspiratory effort, work of breathing, lung injury
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory support levelProcedure or surgery
Inspiratory support is the pressure delivered by the ventilator during pressure support ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory support level with PMI equal to -2 | Experimental | PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion. Receives: Procedure: Inspiratory support level |
| Inspiratory support level with PMI equal to 0 | Experimental | PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion. Receives: Procedure: Inspiratory support level |
| Inspiratory support level with PMI equal to +2 | Experimental | PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion. Receives: Procedure: Inspiratory support level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory effort
Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.
Measured: 30 minutes
Work of breathing
Work of breathing is measured by the Campbell diagram and pressure-time-product using esophageal pressure monitoring.
Measured: 30 minutes
Secondary outcomes (7)
Respiratory system compliance (ml/cmH2O)
Respiratory system compliance is calculated as the ratio between tidal volume and driving pressure.
Measured: 30 minutes
Partial pressure of oxygen in arterial blood (mmHg)
Partial pressure of oxygen in arterial blood is obtained by blood gas analysis.
Measured: Partial pressure of oxygen in arterial blood
Partial pressure of carbon dioxide in arterial blood (mmHg)
Partial pressure of carbon dioxide in arterial blood is obtained by blood gas analysis.
Measured: 30 minutes
Respiratory rate (breaths/min)
Respiratory rate calculation includes ineffective trigger.
Measured: 30 minutes
Tidal volume (ml)
Tidal volume is obtained by intergation of flow-time tracing.
Measured: 30 minutes
Rapid shallow breathing index
Rapid shallow breathing index is calculated as the ratio between respiratory rate and tidal volume.
Measured: 30 minutes
The use of accessory respiratory muscle
The use of accessory respiratory muscle is observed at the bedside.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2021
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
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.
- More trials run by Capital Medical UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026463
- Sponsor's protocol ID
- KY2021-012-01
- Status last verified
- Dec 2021
- First submitted
- 17 Aug 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation
- ClinicalTrials.gov ID
- NCT05026463
- Acronym / sponsor ID
- KY2021-012-01
- Conditions
- Mechanical Ventilation
- Keywords
- mechanical ventilation, pressure support, inspiratory effort, work of breathing, lung injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 30 Aug 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.
Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory support level with PMI equal to -2 | Experimental | Procedure: Inspiratory support levelPMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion. |
| Inspiratory support level with PMI equal to 0 | Experimental | Procedure: Inspiratory support levelPMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion. |
| Inspiratory support level with PMI equal to +2 | Experimental | Procedure: Inspiratory support levelPMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanical ventilated patients within 48 hours after the transition from a controlled mode to PSV
Key exclusion criteria (6 listed)
- History of neuromuscular disease
- History of diaphragm dysfunction and surgery
- History of esophageal, gastric or lung surgery
- Decreased level of consciousness
- Central respiratory drive dysfunction
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 |
|---|---|---|
| Inspiratory support levelInspiratory support is the pressure delivered by the ventilator during pressure support ventilation. | Procedure or surgery | Inspiratory support level with PMI equal to +2, Inspiratory support level with PMI equal to -2, Inspiratory support level with PMI equal to 0 |
Primary outcome
Inspiratory effort
Time frame: 30 minutes
Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.
Work of breathing
Time frame: 30 minutes
Work of breathing is measured by the Campbell diagram and pressure-time-product using esophageal pressure monitoring.
7 secondary outcomes
Respiratory system compliance (ml/cmH2O)
Time frame: 30 minutes
Partial pressure of oxygen in arterial blood (mmHg)
Time frame: Partial pressure of oxygen in arterial blood
Partial pressure of carbon dioxide in arterial blood (mmHg)
Time frame: 30 minutes
Respiratory rate (breaths/min)
Time frame: 30 minutes
Tidal volume (ml)
Time frame: 30 minutes
Rapid shallow breathing index
Time frame: 30 minutes
The use of accessory respiratory muscle
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory support level in people with Mechanical Ventilation, run by Capital Medical University at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD (8610 59978019, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory effort (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 11 Jan 2022.