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Recruiting NCT06368089

Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

No phase Interventional Ventilator Dependent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspiratory muscle training (IMT) group, Early mobilization (EM) group.
Who it may be relevant to
Registry conditions: Ventilator Dependent. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Other 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

Primary outcome measures

  • Maximum inspiratory pressure (MIP) [Time frame: baseline and day 7 after program]
  • Dynamic lung compliance (Cdyn) [Time frame: baseline and day 7 after program]
Secondary outcome measures (4)
  • Weaning time [Time frame: baseline and day 7 after program]
  • Weaning outcome [Time frame: baseline and day 7 after program]
  • Grip strength [Time frame: baseline and day 7 after program]
  • chest wall expansion [Time frame: baseline and day 7 after program]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital — Songkhla

Identifiers

NCT: NCT06368089 · REC.66-474-30-2 · MR-PSU:66-30-21-406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗