Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

Ventilator Dependent Clinical Trial

Official title:

Short Effects of Speci|c Inspiratory Muscle Training and Early Mobilization in Prolonged Mechanically Ventilated Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368089
• Other study ID #: REC.66-474-30-2
• Secondary ID: MR-PSU:66-30-21-
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Prince of Songkla University
• Contact: Saikaew Chuachan, Msc.PT
• Phone: 0849988665
• Email: saikaew.ch[@]psu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The prolonged mechanical ventilation results in difficulty weaning off the ventilator. Inspiratory muscle strength and early mobilization can contribute to the expansion of lung parenchyma and facilitate success in weaning off respiratory support. Thus, this study aimed to explain the impact of inspiratory muscle training and early mobilization on dynamic lung compliance, spontaneous breathing time, and success rate in patients who have undergone mechanical ventilation for more than 48 hours.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Ventilator Dependent

Intervention

Other:
• Inspiratory muscle training (IMT) group
The IMT group receives inspiratory muscle training of 50%MIP, 6 breaths/set 10 sets/day for 7 days combined with conventional chest physiotherapy including; percussion, vibration, postural draining, positioning, and passive range of motion.
• Early mobilization (EM) group
The ER group received active exercise in sitting, standing, and marching 30 minutes/day for 7 days with conventional chest physical therapy

Locations

Country	Name	City	State
Thailand	Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

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