Serial Diaphragm Ultrasound Evaluation During Inspiratory Muscle Training in Prolonged Mechanical… (NCT07709793) | Clinical Trial Compass
CompletedNot Applicable
Serial Diaphragm Ultrasound Evaluation During Inspiratory Muscle Training in Prolonged Mechanical Ventilation
Taiwan36 participantsStarted 2023-03-09
Plain-language summary
Diaphragm dysfunction contributes to prolonged mechanical ventilation (PMV) and difficult weaning. Inspiratory muscle training (IMT) may improve respiratory muscle performance, while serial diaphragm ultrasound offers a bedside method for monitoring diaphragmatic recovery. This study used diaphragm ultrasound to evaluate the effects of high- versus low-intensity IMT in patients with PMV and diaphragm dysfunction.
In this prospective study, patients received high- or low-intensity IMT for up to 2 weeks or until ventilator liberation. Respiratory mechanics, including respiratory rate, tidal volume, minute ventilation, rapid shallow breathing index, and maximal inspiratory pressure, were assessed twice weekly. Diaphragm excursion and thickening fraction were also measured serially after IMT initiation. Changes in respiratory physiological parameters and diaphragm ultrasound measurements were compared between the two IMT groups, and differences in ventilator liberation outcomes were evaluated.
Who can participate
Age range
20 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide written informed consent.
. Adults aged \>20 years.
. Patients requiring mechanical ventilation for \>21 days and admitted to the Respiratory Care Center (RCC).
. Hemodynamically stable and not receiving vasopressor therapy.
. Clinically stable and considered by the attending physician to be ready to begin weaning from mechanical ventilation. Ventilator settings must meet all of the following criteria:
Exclusion criteria
. Hemodynamic instability, including cardiac arrhythmia, decompensated heart failure, or acute coronary syndrome.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in diaphragm excursion measured by diaphragm ultrasound
Timeframe: From enrollment to the end of study at 2 weeks.
2
Changes in thickening fraction measured by diaphragm ultrasound
Timeframe: From enrollment to the end of study at 2 weeks.