Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

Not Applicable

Recruiting

• Conditions: Ventilator Dependent
• Interventions: Other: Early mobilization (EM) group; Other: Inspiratory muscle training (IMT) group

• Registration Number: NCT06368089
• Lead Sponsor: Prince of Songkla University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-16
• Study Start: 2024-05-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EM group	Early mobilization (EM) group	Early mobilization group
IMT group	Inspiratory muscle training (IMT) group	Inspiratory muscle training group

Primary Outcome Measures

Name	Time	Method
Maximum inspiratory pressure (MIP)	baseline and day 7 after program	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.
Dynamic lung compliance (Cdyn)	baseline and day 7 after program	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

Secondary Outcome Measures

Name	Time	Method
Weaning outcome	baseline and day 7 after program	measure weaning success rate
chest wall expansion	baseline and day 7 after program	measure by using tape at the axillary, xiphoid process, and umbrilical level
Grip strength	baseline and day 7 after program	using hand grip dynamometer
Weaning time	baseline and day 7 after program	Duration of weaning time (hour)

Trial Locations

Locations (1)

Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital; 🇹🇭 Songkhla, Thailand