Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

NCT06368089 | Recruiting DMC

• 2 other identifiers: REC.66-474-30-2MR-PSU:66-30-21-406
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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. 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. 2.Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program.

Conditions

Ventilator Dependent

Keywords

Specific inspiratory muscle training; Early mobilization; Lung compliance; Prolong mechanical ventilation; Weaning outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Weaning time

  baseline and day 7 after program

• Weaning outcome

  baseline and day 7 after program

• Grip strength

  baseline and day 7 after program

• chest wall expansion

  baseline and day 7 after program

Study Arms (2)

IMT group

EXPERIMENTAL

Inspiratory muscle training group

Other: Inspiratory muscle training (IMT) group

EM group

ACTIVE COMPARATOR

Early mobilization group

Other: Early mobilization (EM) group

Interventions

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.

IMT group

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

EM group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

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

Songkhla, 90110, Thailand

RECRUITING

MeSH Terms

Interventions

Population Groups; Early Ambulation

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Saikaew Chuachan

  Department of Physical Therapy, Faculty of Medicine, PSU

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Saikaew Chuachan, Msc.PT

CONTACT

0849988665; saikaew.ch@psu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Therapy, Faculty of Medicine

Model Details: randomization

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 16, 2024
• Study Start: May 6, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

TH (1)