Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

NCT ID: NCT06368089

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2026-03-31

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.

Conditions

Ventilator Dependent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMT group

Inspiratory muscle training group

Group Type: EXPERIMENTAL

Inspiratory muscle training (IMT) group

Intervention Type: 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.

EM group

Early mobilization group

Group Type: ACTIVE_COMPARATOR

Early mobilization (EM) group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: lead

Responsible Party

Saikaew Chuachan

Department of Physical Therapy, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saikaew Chuachan

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy, Faculty of Medicine, PSU

Natcha Kimthiaw, Bsc.PT

Role: STUDY_DIRECTOR

Department of Physical Therapy, Faculty of Medicine, PSU

Luksamee Kaewchano, Bsc.PT

Role: STUDY_DIRECTOR

Department of Physical Therapy, Faculty of Medicine, PSU

Ittiphon Pannarai, Bsc.PT

Role: STUDY_DIRECTOR

Department of Physical Therapy, Faculty of Medicine, PSU

Jatuporn Jaturawanit, Bsc.PT

Role: STUDY_DIRECTOR

Physical Therapy unit, Songklanakarind Hospital

Jitsupa Kittarakul, Bsc.PT

Role: STUDY_DIRECTOR

Physical Therapy unit, Songklanakarind Hospital

Boonmas Chansirimongkol, B.N.S.

Role: STUDY_DIRECTOR

Medical Respiratory Care Unit, Prince of Songklanakarind Hospital

Kwankamol Kalsri, B.N.S

Role: STUDY_DIRECTOR

Medical Respiratory Care Unit, Prince of Songklanakarind Hospital

Assoc.Prof.Siwasak Juthong, MD

Role: STUDY_DIRECTOR

Division of Respiratory and Respiratory Critical Care Medicine, Department of Internal Medicine, PSU

Locations

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

Songkhla, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Saikaew Chuachan, Msc.PT

Role: CONTACT

saikaew.ch@psu.ac.th

0849988665

Other Identifiers

MR-PSU:66-30-21-406

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REC.66-474-30-2

Identifier Type: -

Identifier Source: org_study_id