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NCT Number: NCT06368089

Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

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.

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Key information

Conditions

Ventilator Dependent

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital

Songkhla, 90110, Thailand

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory muscle training (IMT) group

Other

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

The ER group received active exercise in sitting, standing, and marching 30 minutes/day for 7 days with conventional chest physical therapy

Primary outcomes

  1. Maximum inspiratory pressure (MIP)

    Time frame: 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.

  2. Dynamic lung compliance (Cdyn)

    Time frame: 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 outcomes

  1. Weaning time

    Time frame: baseline and day 7 after program

    Duration of weaning time (hour)

  2. Weaning outcome

    Time frame: baseline and day 7 after program

    measure weaning success rate

  3. Grip strength

    Time frame: baseline and day 7 after program

    using hand grip dynamometer

  4. chest wall expansion

    Time frame: baseline and day 7 after program

    measure by using tape at the axillary, xiphoid process, and umbrilical level

Study contacts

Contact information is provided by the study sponsor or research team.

Saikaew Chuachan, Msc.PT

CONTACT

[email protected]

0849988665

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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