NCT05963737 PMI Guide PS Setting in Pressure Support-ventilated Patients
| NCT ID | NCT05963737 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capital Medical University |
| Condition | Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-12 |
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 60 participants in total. It began in 2023-08-01 with a primary completion date of 2025-12.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * Patients under PSV * Predicted ventilated time of more than 48 hours. Exclusion Criteria: * 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; * Broncho-pleural fistula; * Chronic obstructive pulmonary disease (COPD); * Pressure support ventilated time more than 48 hours before randomization.
Frequently Asked Questions
Who can join the NCT05963737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT05963737 currently recruiting?
Yes, NCT05963737 is actively recruiting participants. Visit ClinicalTrials.gov or contact Capital Medical University to inquire about joining.
Where is the NCT05963737 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05963737 clinical trial?
NCT05963737 is sponsored by Capital Medical University. The trial plans to enroll 60 participants.