Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

Prince of Songkla University

Status: Enrolling

Conditions: Ventilator Dependent

Treatments: Other: Inspiratory muscle training (IMT) group; Other: Early mobilization (EM) group

Study type: Interventional

Funder types: Other

Identifiers

NCT06368089

MR-PSU:66-30-21-406 (Other Grant/Funding Number)

REC.66-474-30-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

IMT group

Experimental group

Description:

Inspiratory muscle training group

Treatment:

Other: Inspiratory muscle training (IMT) group

EM group

Active Comparator group

Description:

Early mobilization group

Treatment:

Other: Early mobilization (EM) group