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

NCT00792441 | Unknown DMC

• 2 other identifiers: KKU4950900071HE501034
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 2.SIMT will improve lung function in patients with ventilatory dependence.
3. 3.SIMT will improve weaning success in patients with ventilatory dependence.

Conditions

Ventilatory Defect

Keywords

Specific inspiratory muscle training(SIMT); Loaded deep breathing; Weaning; Mechanical ventilation; Respiratory muscle

Outcome Measures

Primary Outcomes (1)

• Peak Negative Inspiratory Pressure (PNIP)

  every 7 day for 28 days

Secondary Outcomes (11)

• 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.

Study Arms (1)

intervention group

NO INTERVENTION

Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University

Device: intervention group

Interventions

intervention group DEVICE

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.

Also known as: BreatheMax v.1, water pressure threshold breathing (WPTB)

intervention group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saikaew Chuachan: lead
• Khon Kaen University: collaborator

Study Sites (1)

Respiratory Intensive Care Unit (RICU),Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Study Officials

• 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 DIRECTOR

• Saikaew Chuachan, Bachelor

  Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Medical Science

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 18, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

TH (1)