Clinical trial NCT06368089: Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients
Official title: Short Effects of Speci|c Inspiratory Muscle Training and Early Mobilization in Prolonged Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilator Dependent
Keywords: Specific inspiratory muscle training
Early mobilization
Lung compliance
Prolong mechanical ventilation
Weaning outcome
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization
Primary purpose: TREATMENT

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.

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 \&gt; 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 \&gt; 120 beats/minute, RR \&gt; 30 breaths/minute, SatO2 \&lt; 90%, SBP \&gt; 140 mmHg or \&lt; 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 \&lt; 10) and inability to cooperate with training (Riker score \&lt; 4 or \&gt; 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 (\&gt; 5 micrograms per kilogram per minute)
* Heart rate \&gt; 140 beats per minute
* Hemoglobin levels \&lt; 8-10 grams per deciliter
* Patients with difficult airway issues.

Primary outcomes:
measure: Maximum inspiratory pressure (MIP)
timeFrame: baseline and day 7 after program
measure: Dynamic lung compliance (Cdyn)
timeFrame: baseline and day 7 after program
Secondary outcomes:
measure: Weaning time
timeFrame: baseline and day 7 after program
measure: Weaning outcome
timeFrame: baseline and day 7 after program
measure: Grip strength
timeFrame: baseline and day 7 after program
measure: chest wall expansion
timeFrame: baseline and day 7 after program
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital
Study officials:
affiliation: Department of Physical Therapy, Faculty of Medicine, PSU
name: Saikaew Chuachan
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Therapy, Faculty of Medicine, PSU
name: Natcha Kimthiaw, Bsc.PT
role: STUDY_DIRECTOR
affiliation: Department of Physical Therapy, Faculty of Medicine, PSU
name: Luksamee Kaewchano, Bsc.PT
role: STUDY_DIRECTOR
affiliation: Department of Physical Therapy, Faculty of Medicine, PSU
name: Ittiphon Pannarai, Bsc.PT
role: STUDY_DIRECTOR
affiliation: Physical Therapy unit, Songklanakarind Hospital
name: Jatuporn Jaturawanit, Bsc.PT
role: STUDY_DIRECTOR
affiliation: Physical Therapy unit, Songklanakarind Hospital
name: Jitsupa Kittarakul, Bsc.PT
role: STUDY_DIRECTOR
affiliation: Medical Respiratory Care Unit, Prince of Songklanakarind Hospital
name: Boonmas Chansirimongkol, B.N.S.
role: STUDY_DIRECTOR
affiliation: Medical Respiratory Care Unit, Prince of Songklanakarind Hospital
name: Kwankamol Kalsri, B.N.S
role: STUDY_DIRECTOR
affiliation: Division of Respiratory and Respiratory Critical Care Medicine, Department of Internal Medicine, PSU
name: Assoc.Prof.Siwasak Juthong, MD
role: STUDY_DIRECTOR
References: