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

Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: Ventilatory Defect
• Intervention / Treatment: Device: intervention group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Respiratory Intensive Care Unit (RICU),Srinagarind Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Negative Inspiratory Pressure (PNIP)	every 7 day for 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Lung compliance	every 7 day for 28 days
Vital capacity	every 7 day for 28 days
Rate perceived breathlessness	every 7 day for 28 day
Airway resistance	every 7 day for 28 days.
Tidal volume	every 7 day for 28 days.
Minute ventilation	every 7 day for 28 days.
End tidal carbondioxide (PetCO2)	every 7 day for 28 days.
SpO2	every 7 day for 28 days.
Heart rate	every 7 day for 28 days.
Respiratory rate	every 7 day for 28 days.
Weaning success	every 7 day for 28 days.

Collaborators and Investigators

• Sponsor: Saikaew Chuachan
• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 17, 2008
• First Posted (ESTIMATE): November 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Weaning; Mechanical ventilation; Respiratory muscle; Specific inspiratory muscle training(SIMT); Loaded deep breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: KKU4950900071; HE501034 (OTHER: KKU)