NCT05950893 The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation
| NCT ID | NCT05950893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jian-Xin Zhou |
| Condition | Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-03-25 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2023-03-25 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is critical to maintain a relatively normal inspiratory effort during pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort. The inspiratory muscle pressure index (PMI) can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain. Previous studies on PMI were based on physiological research and experimental conditions (PMIref), which require special pressure monitoring devices and software to collect and measure airway pressure. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). The overall aim of this study was to determine PMIvent's clinical feasibility and validity for accessing inspiratory effort during PSV.
Eligibility Criteria
Inclusion Criteria: Adult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode Exclusion Criteria: 1. age younger than 18 years old or older than 85 years 2. known pregnancy and parturient 3. chronic occlusive pulmonary diseases 4. gastric, esophageal injury 5. barotrauma 6. diaphragm dysfunction 7. intracranial hypertension and brain stem injury 8. consciousness level decreased (RASS less than -2 scores) 9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05950893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05950893 currently recruiting?
Yes, NCT05950893 is actively recruiting participants. Contact the research team at zhoujx.cn@icloud.com for enrollment information.
Where is the NCT05950893 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05950893 clinical trial?
NCT05950893 is sponsored by Jian-Xin Zhou. The trial plans to enroll 25 participants.