Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

ConditionVentilator Dependent

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-80

SponsorPrince of Songkla University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Inspiratory muscle training (IMT) group
Other intervention
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
Other intervention
The ER group received active exercise in sitting, standing, and marching 30 minutes/day for 7 days with conventional chest physical therapy

Treatment groups

46 Participants

are divided into 2 treatment groups

Group A: IMT groupExperimental treatment 1 intervention

Group B: EM groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame