COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence (SIMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792441
Recruitment Status : Unknown
Verified April 2015 by Saikaew Chuachan, Khon Kaen University.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2008
Last Update Posted : April 3, 2015
Khon Kaen University
Information provided by (Responsible Party):
Saikaew Chuachan, Khon Kaen University

Brief Summary:

Prolong mechanical ventilation cause to respiratory muscle weakness and high risk to weaning failure,the investigators hypothesize that

  1. Specific inspiratory muscle training (SIMT) using threshold loaded breathing device (BreatheMAX V.1)in patients with ventilator dependence will improve inspiratory muscle strength
  2. SIMT will improve lung function in patients with ventilatory dependence.
  3. SIMT will improve weaning success in patients with ventilatory dependence.

Condition or disease Intervention/treatment Phase
Ventilatory Defect Device: intervention group Not Applicable

Detailed Description:
Prolonged mechanical ventilation cause detrimental effects on lung function and high risk of lung complications and standard weaning protocols are not successful in a number of patients. The strength of the inspiratory muscles is important factors in the success of weaning. Although, the inspiratory muscles are trained by manipulating the ventilator sensitivity and made of ventilation in the traditional protocol, the muscle function might not improved sufficiently to sustain independent and spontaneous breathing. Consequently, specific inspiratory muscle training is indicated and has been studied in patient with weaning failure. However, there is little evidence available and no firm conclusion can be drown. Therefore, the purpose of this study is to determine whether specific IMT training using the local made loaded threshold IMT device can improve lung function and accelerate the weaning process.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes
Study Start Date : January 2007
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
No Intervention: intervention group
Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University
Device: intervention group
inspiratory muscle training at 50% of peak negative inspiratory muscle training (PNIP)will be performed with 6 breathe/set, 10 set/day, once a day for 28 days.
Other Names:
  • BreatheMax v.1
  • water pressure threshold breathing (WPTB)

Primary Outcome Measures :
  1. Peak Negative Inspiratory Pressure (PNIP) [ Time Frame: every 7 day for 28 days ]

Secondary Outcome Measures :
  1. Lung compliance [ Time Frame: every 7 day for 28 days ]
  2. Vital capacity [ Time Frame: every 7 day for 28 days ]
  3. Rate perceived breathlessness [ Time Frame: every 7 day for 28 day ]
  4. Airway resistance [ Time Frame: every 7 day for 28 days. ]
  5. Tidal volume [ Time Frame: every 7 day for 28 days. ]
  6. Minute ventilation [ Time Frame: every 7 day for 28 days. ]
  7. End tidal carbondioxide (PetCO2) [ Time Frame: every 7 day for 28 days. ]
  8. SpO2 [ Time Frame: every 7 day for 28 days. ]
  9. Heart rate [ Time Frame: every 7 day for 28 days. ]
  10. Respiratory rate [ Time Frame: every 7 day for 28 days. ]
  11. Weaning success [ Time Frame: every 7 day for 28 days. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient who have been mechanically ventilated > 72 hours and start to weaning from medical order or ventilator dependent patients who have failed to wean prior to study.
  • Normal arterial blood gas (PaCO2 < 50mmHg, PaO2 > 60 mmHg on FiO2 <0.5 or SaO2 > 90%, PH 7.35-7.45).
  • Cardiovascular stability (HR ≤ 140 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg, with no or minimal vasopressors)
  • Good consciousness, cooperation and can sit in an upright position > 30 minutes

Exclusion Criteria:

  • Persistent homodynamic instability.
  • Severe breathlessness at rest when spontaneous breathing.
  • Coronary heart disease with angina.
  • Life threatening arrhythmia (VF, VT).
  • Sedation Ramsay scale > 2
  • Severity of disease APACHE II score > 29

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792441

Layout table for location information
Respiratory Intensive Care Unit (RICU),Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Saikaew Chuachan
Khon Kaen University
Layout table for investigator information
Study Director: Reechaipichitkul Wipa, MD Department of medicine, Faculty of medicine, Khon Kaen university
Study Director: Chulee CU Jones, Philosophy Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Study Chair: Saikaew Chuachan, Bachelor Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university

Layout table for additonal information
Responsible Party: Saikaew Chuachan, Associated Medical Science, Khon Kaen University Identifier: NCT00792441    
Other Study ID Numbers: KKU4950900071
HE501034 ( Other Identifier: KKU )
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by Saikaew Chuachan, Khon Kaen University:
Specific inspiratory muscle training(SIMT)
Loaded deep breathing
Mechanical ventilation
Respiratory muscle
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes