Ventilator Dependent Clinical Trial
Official title:
Short Effects of Speci|c Inspiratory Muscle Training and Early Mobilization in Prolonged Mechanically Ventilated Patients
Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to: 1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period. 2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program.
| Status | Not yet recruiting |
| Enrollment | 46 |
| Est. completion date | March 2026 |
| Est. primary completion date | February 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Patients with respiratory diseases who have been on mechanical ventilation for more than 48 hours and are ready to be weaned off or undergoing weaning trials with continuous positive airway pressure (CPAP) or synchronized intermittent mandatory ventilation (SIMV). - The PaO2/FiO2 ratio is = 150-200, with FiO2 = 0.4-0.5 and PEEP = 5-8 cmH2O, and a pH > 7.3 in blood plasma. - The age range is between 40 and 80 years old. - Patients exhibit good self-awareness and cooperation in training (Riker score of 4). - They can understand and communicate in Thai Exclusion Criteria: - Clinical instability (HR > 120 beats/minute, RR > 30 breaths/minute, SatO2 < 90%, SBP > 140 mmHg or < 90 mmHg) - Patients who can be extubated and use non-invasive ventilation only or successfully extubated within the first 24 hours. - Patients with altered mental status (Glasgow Coma Score < 10) and inability to cooperate with training (Riker score < 4 or > 4) - Patients with limitations or contraindications such as inability to adjust the bed to a 45-degree angle or sit on the side of the bed, such as those with spinal cord injuries or recent head surgeries. - History of hemoptysis, pneumothorax - History of neuromuscular diseases causing muscle weakness and decreased sensation. - Patients with excessive cardiac stimulation (> 5 micrograms per kilogram per minute) - Heart rate > 140 beats per minute - Hemoglobin levels < 8-10 grams per deciliter - Patients with difficult airway issues. |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital | Songkhla |
| Lead Sponsor | Collaborator |
|---|---|
| Prince of Songkla University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum inspiratory pressure (MIP) | MIP measurement using manometer, the device can be attached directly to the ETT or tracheostomy tube, and measures the pressure generated by patient on inhalation against a closed system. | baseline and day 7 after program | |
| Primary | Dynamic lung compliance (Cdyn) | Dynamic lung compliance refers to the ratio of the change in volume to the change in pressure over a tidal breath, with the pressure measured at moments of zero flow during breathing that recording from the mechanical ventilation | baseline and day 7 after program | |
| Secondary | Weaning time | Duration of weaning time (hour) | baseline and day 7 after program | |
| Secondary | Weaning outcome | measure weaning success rate | baseline and day 7 after program | |
| Secondary | Grip strength | using hand grip dynamometer | baseline and day 7 after program | |
| Secondary | chest wall expansion | measure by using tape at the axillary, xiphoid process, and umbrilical level | baseline and day 7 after program |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00419458 -
Inspiratory Muscle Training in Ventilator Dependent Patients
|
Phase 1 |