Mechanical VentilationNCT05963737
PMI Guide PS Setting in Pressure Support-ventilated Patients
A study testing PS setting strategy in pressure-support ventilated patients in people with Mechanical Ventilation, run by Capital Medical University at 1 site in China.
Trial summary
Pressure support ventilation (PSV) is an assistant mechanical ventilation mode, that is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- PS setting strategy in pressure-support ventilated patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under PSV
- Predicted ventilated time of more than 48 hours.
Who cannot join
- Age less than 18 years old;
- Known pregnancy;
- BMI>35kg/m2;
- Brain-stem or cervical cord injury;
- Known or clinically suspected elevated intracranial pressure (ICP>18 mmHg);
- Nervus phrenicus or diaphragm injury;
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- Broncho-pleural fistula;
- Chronic obstructive pulmonary disease (COPD);
- Pressure support ventilated time more than 48 hours before randomization.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100071
Jian-Xin Zhou, MD, 8610 59978019, zhoujx.cn@icloud.com
Ran Gao, +8617647611107, 1205961482@qq.com
About this study
Official title: PMI Guide PS Setting in Pressure Support-ventilated Patients - Prospective Multicenter Clinical RCT
Pressure support ventilation (PSV) is an assistant mechanical ventilation mode, that is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Traditional PS setting strategy (VT/PBW 6-8ml/kg and RR 20-30 breaths/min)has risks of excessive or insufficient assistance. Inspiratory muscle pressure index (PMI) is a noninvasive respiratory mechanical indicator and is available at the bedside. PMI was correlated with inspiratory effort and has the potential ability to predict low inspiratory effort and high inspiratory effort. The primary objective of this study is to investigate the clinical validity of a PMI-guided PS setting strategy. Specifically, the investigators aim to evaluate its impact on inspiratory effort as well as its potential for lung and diaphragm protection. Additionally, the investigators seek to assess the effect of this ventilation strategy on mechanical ventilation outcomes while evaluating the feasibility of our trial protocol.
Read the detailed description
Pressure support ventilation (PSV) is an assistant mechanical ventilation mode to provide synchronous inspiratory support for patients with spontaneous breathing and to efficiently reduce the workload imposed on the respiratory muscle. PSV is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Clinicians and respiratory therapists usually adjust ventilator parameters based on tidal volume/predicted body weight (VT/PBW, 6-8ml/kg) and current respiratory rate (RR, 20-30 breaths/min). This strategy has risks of excessive or insufficient assistance because the PS setting cannot be modulated dynamically based on the requirements of ventilated patients.
Inspiratory muscle pressure index (Pmus index, PMI) is defined as the difference between plateau pressure (Pplat) and airway peak pressure (Ppeak) during end-inspiratory occlusion (EIO). PMI is a noninvasive respiratory mechanical indicator and is available at the bedside like airway occlusion pressure (P0.1) because holding operations were integrated into the majority ventilator. Several studies showed PMI was correlated with inspiratory effort. Our previous study showed PMI has the potential ability to predict low inspiratory effort and high inspiratory effort, and the optimal cut-off PMI value was approximately 0 cmH2O and 2 cmH2O.
The primary objective of this study is to investigate the clinical validity of a PMI-guided PS setting strategy. Specifically, the investigators aim to evaluate its impact on inspiratory effort as well as its potential for lung and diaphragm protection. Additionally, the investigators seek to assess the effect of this ventilation strategy on mechanical ventilation outcomes while evaluating the feasibility of our trial protocol.
- Conditions
- Mechanical Ventilation
- Being tested
- PS setting strategy in pressure-support ventilated patients
- Keywords
- pressure support ventilation, inspiratory effort, inspiratory muscle pressure index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS setting strategy in pressure-support ventilated patientsProcedure or surgery
Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | The initial PS level is set up based on VT/PBW (6-8ml/kg) and RR (20-30 breaths/min) when patients are enrolled in the experimental arm. The following steps need to be repeated every 2 hours for 48 hours. Step 1: 3 times short EIOs (2-3s) are performed. At least 1 minute between each occlusion. PMI is calculated as the mean value of 3 measured values. Step 2: Clarify whether PMI is in the target range (PMI 0-2cmH2O). If yes, keep this PS level. If not, implement step 3. Step 3: A downward or upward PS setting adjustment is performed at a 1cmH2O interval. Every PS level is maintained for 3-5 minutes. PMI is measured again and step 3 is repeated until the PMI target is reached. Step 4: supplemental adjustment: PS setting needs to be returned to the previous level if the patient presents the following signs: VT < 4 ml/Kg, RR > 35 breaths/min, respiratory acidosis, respiratory distress, VT > 10ml/Kg, Pplat > 30 cmH2O, respiratory alkalosis. Receives: Procedure: PS setting strategy in pressure-support ventilated patients |
| Control arm | No intervention | Patients randomized to the control arm need to continue to accept the traditional ventilation strategy which is VT/PBW (6-8ml/kg) and RR (20-30breaths/min) guide PS setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of conditions in the range of normal inspiratory effort per patient
the time from the start of PSV mode to the successful weaning of the ventilated patients
Measured: up to 48 hours
Secondary outcomes (9)
The duration of mechanical ventilation
the time from the start of mechanical ventilaion to the successful weaning of the patients
Measured: up to 28 days
Tracheostomy rate
the proportion of all subjects who underwent tracheostomy
Measured: up to 28 days
Reintubation rate
the proportion of all subjects who underwent reintubation
Measured: up to 28 days
Diaphragm thickness (Tdi)
using the Tdi to estimate the change of diaphragm function and activity during PSV
Measured: up to 28 days
Diaphragm thicken fraction (TFdi)
using the TFdi to estimate the change of diaphragm function and activity during PSV
Measured: up to 28 days
Diaphragm excursion (EXdi)
using the EXdi to estimate the change of diaphragm function and activity during PSV
Measured: up to 28 days
inspiratory muscle pressure (Pmus)
measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
Measured: up to 28 days
esophageal pressure time product (PTPes)
measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
Measured: up to 28 days
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
treatment-related adverse events including pneumothorax, circulatory instability, etc.
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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
- NCT05963737
- Sponsor's protocol ID
- KY2023-005-02
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao R, Yang YL, Zhang L, Miao MY, Zhou JX. Use of pressure muscle index to guide pressure support ventilation setting: a study protocol and statistical plan for a prospective randomised controlled proof-of-concept trial. BMJ Open. 2024 Aug 3;14(8):e082395. doi: 10.1136/bmjopen-2023-082395.
PubMed 39097307
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMI Guide PS Setting in Pressure Support-ventilated Patients - Prospective Multicenter Clinical RCT
- ClinicalTrials.gov ID
- NCT05963737
- Acronym / sponsor ID
- KY2023-005-02
- Conditions
- Mechanical Ventilation
- Keywords
- pressure support ventilation, inspiratory effort, inspiratory muscle pressure index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jul 2023 (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 an assistant mechanical ventilation mode, that is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Traditional PS setting strategy (VT/PBW 6-8ml/kg and RR 20-30 breaths/min)has risks of excessive or insufficient assistance. Inspiratory muscle pressure index (PMI) is a noninvasive respiratory mechanical indicator and is available at the bedside. PMI was correlated with inspiratory effort and has the potential ability to predict low inspiratory effort and high inspiratory effort. The primary objective of this study is to investigate the clinical validity of a PMI-guided PS setting strategy. Specifically, the investigators aim to evaluate its impact on inspiratory effort as well as its potential for lung and diaphragm protection. Additionally, the investigators seek to assess the effect of this ventilation strategy on mechanical ventilation outcomes while evaluating the feasibility of our trial protocol.
Detailed description
Pressure support ventilation (PSV) is an assistant mechanical ventilation mode to provide synchronous inspiratory support for patients with spontaneous breathing and to efficiently reduce the workload imposed on the respiratory muscle. PSV is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Clinicians and respiratory therapists usually adjust ventilator parameters based on tidal volume/predicted body weight (VT/PBW, 6-8ml/kg) and current respiratory rate (RR, 20-30 breaths/min). This strategy has risks of excessive or insufficient assistance because the PS setting cannot be modulated dynamically based on the requirements of ventilated patients.
Inspiratory muscle pressure index (Pmus index, PMI) is defined as the difference between plateau pressure (Pplat) and airway peak pressure (Ppeak) during end-inspiratory occlusion (EIO). PMI is a noninvasive respiratory mechanical indicator and is available at the bedside like airway occlusion pressure (P0.1) because holding operations were integrated into the majority ventilator. Several studies showed PMI was correlated with inspiratory effort. Our previous study showed PMI has the potential ability to predict low inspiratory effort and high inspiratory effort, and the optimal cut-off PMI value was approximately 0 cmH2O and 2 cmH2O.
The primary objective of this study is to investigate the clinical validity of a PMI-guided PS setting strategy. Specifically, the investigators aim to evaluate its impact on inspiratory effort as well as its potential for lung and diaphragm protection. Additionally, the investigators seek to assess the effect of this ventilation strategy on mechanical ventilation outcomes while evaluating the feasibility of our trial protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: PS setting strategy in pressure-support ventilated patientsThe initial PS level is set up based on VT/PBW (6-8ml/kg) and RR (20-30 breaths/min) when patients are enrolled in the experimental arm. The following steps need to be repeated every 2 hours for 48 hours. Step 1: 3 times short EIOs (2-3s) are performed. At least 1 minute between each occlusion. PMI is calculated as the mean value of 3 measured values. Step 2: Clarify whether PMI is in the target range (PMI 0-2cmH2O). If yes, keep this PS level. If not, implement step 3. Step 3: A downward or upward PS setting adjustment is performed at a 1cmH2O interval. Every PS level is maintained for 3-5 minutes. PMI is measured again and step 3 is repeated until the PMI target is reached. Step 4: supplemental adjustment: PS setting needs to be returned to the previous level if the patient presents the following signs: VT < 4 ml/Kg, RR > 35 breaths/min, respiratory acidosis, respiratory distress, VT > 10ml/Kg, Pplat > 30 cmH2O, respiratory alkalosis. |
| Control arm | No intervention | –Patients randomized to the control arm need to continue to accept the traditional ventilation strategy which is VT/PBW (6-8ml/kg) and RR (20-30breaths/min) guide PS setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients under PSV
- Predicted ventilated time of more than 48 hours.
Key exclusion criteria (9 listed)
- Age less than 18 years old;
- Known pregnancy;
- BMI>35kg/m2;
- Brain-stem or cervical cord injury;
- Known or clinically suspected elevated intracranial pressure (ICP>18 mmHg);
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 |
|---|---|---|
| PS setting strategy in pressure-support ventilated patientsUse PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O). | Procedure or surgery | Experimental arm |
Primary outcome
The proportion of conditions in the range of normal inspiratory effort per patient
Time frame: up to 48 hours
the time from the start of PSV mode to the successful weaning of the ventilated patients
9 secondary outcomes
The duration of mechanical ventilation
Time frame: up to 28 days
Tracheostomy rate
Time frame: up to 28 days
Reintubation rate
Time frame: up to 28 days
Diaphragm thickness (Tdi)
Time frame: up to 28 days
Diaphragm thicken fraction (TFdi)
Time frame: up to 28 days
Diaphragm excursion (EXdi)
Time frame: up to 28 days
inspiratory muscle pressure (Pmus)
Time frame: up to 28 days
esophageal pressure time product (PTPes)
Time frame: up to 28 days
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 39097307Gao R, Yang YL, Zhang L, Miao MY, Zhou JX. Use of pressure muscle index to guide pressure support ventilation setting: a study protocol and statistical plan for a prospective randomised controlled proof-of-concept trial. BMJ Open. 2024 Aug 3;14(8):e082395. doi: 10.1136/bmjopen-2023-082395.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS setting strategy in pressure-support ventilated patients in people with 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 9 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 9 Jan 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of conditions in the range of normal inspiratory effort per patient (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963737, which also lists 1 linked publication.
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 9 Jan 2025; AzTrials last refreshed its copy on 2 Nov 2026.