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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Khon Kaen University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00792441
First received: November 17, 2008
Last updated: November 28, 2008
Last verified: November 2008
  Purpose

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 Intervention
Ventilatory Dependence
Device: inspiratory muscle training (IMT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Peak Negative Inspiratory Pressure (PNIP) [ Time Frame: every 7 day for 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lung compliance [ Time Frame: every 7 day for 28 days ] [ Designated as safety issue: Yes ]
  • Vital capacity [ Time Frame: every 7 day for 28 days ] [ Designated as safety issue: Yes ]
  • Rate perceived breathlessness [ Time Frame: every 7 day for 28 day ] [ Designated as safety issue: Yes ]
  • Airway resistance [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]
  • Tidal volume [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]
  • Minute ventilation [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]
  • End tidal carbondioxide (PetCO2) [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]
  • SpO2 [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]
  • Heart rate [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]
  • Respiratory rate [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]
  • Weaning success [ Time Frame: every 7 day for 28 days. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients with ventilatory dependence Device: inspiratory muscle training (IMT)
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)

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792441

Locations
Thailand
Respiratory Intensive Care Unit (RICU),Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
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
  More Information

No publications provided

Responsible Party: Khon Kaen University (Graduate School ), Khon Kaen University
ClinicalTrials.gov Identifier: NCT00792441     History of Changes
Other Study ID Numbers: KKU4950900071, HE501034
Study First Received: November 17, 2008
Last Updated: November 28, 2008
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Specific inspiratory muscle training(SIMT)
Loaded deep breathing
Weaning
Mechanical ventilation

Additional relevant MeSH terms:
Respiratory Aspiration
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014