Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

Short Effects of Speci|c Inspiratory Muscle Training and Early Mobilization 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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator Dependent
• Intervention / Treatment: Other: Inspiratory muscle training (IMT) group; Other: Early mobilization (EM) group

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saikaew Chuachan, Msc.PT; Phone Number: 0849988665; Email: saikaew.ch@psu.ac.th

Study Locations

• Thailand
  • Songkhla, Thailand, 90110
    • Recruiting
    • Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMT group; Inspiratory muscle training group	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.
Active Comparator: EM group; Early mobilization group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and day 7 after program
Dynamic lung compliance (Cdyn)	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	baseline and day 7 after program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weaning time	Duration of weaning time (hour)	baseline and day 7 after program
Weaning outcome	measure weaning success rate	baseline and day 7 after program
Grip strength	using hand grip dynamometer	baseline and day 7 after program
chest wall expansion	measure by using tape at the axillary, xiphoid process, and umbrilical level	baseline and day 7 after program

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Saikaew Chuachan, Department of Physical Therapy, Faculty of Medicine, PSU; Study Director: Natcha Kimthiaw, Bsc.PT, Department of Physical Therapy, Faculty of Medicine, PSU; Study Director: Luksamee Kaewchano, Bsc.PT, Department of Physical Therapy, Faculty of Medicine, PSU; Study Director: Ittiphon Pannarai, Bsc.PT, Department of Physical Therapy, Faculty of Medicine, PSU; Study Director: Jatuporn Jaturawanit, Bsc.PT, Physical Therapy unit, Songklanakarind Hospital; Study Director: Jitsupa Kittarakul, Bsc.PT, Physical Therapy unit, Songklanakarind Hospital; Study Director: Boonmas Chansirimongkol, B.N.S., Medical Respiratory Care Unit, Prince of Songklanakarind Hospital; Study Director: Kwankamol Kalsri, B.N.S, Medical Respiratory Care Unit, Prince of Songklanakarind Hospital; Study Director: Assoc.Prof.Siwasak Juthong, MD, Division of Respiratory and Respiratory Critical Care Medicine, Department of Internal Medicine, PSU

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Early mobilization; Lung compliance; Weaning outcome; Specific inspiratory muscle training; Prolong mechanical ventilation
• Other Study ID Numbers: REC.66-474-30-2; MR-PSU:66-30-21-406 (Other Grant/Funding Number: Faculty of Medicine, Prince of Songkla University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No