Inspiratory Muscle Training in Weaning

Weaning Clinical Trial

— IMT  

Official title:

Weaning Process in Elderly Intubated Patients Submitted to Inspiratory Muscle Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922493
• Other study ID #: 250525
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2009
• Last updated: June 17, 2009
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: June 2009
• Source: Euro-American Network of Human Kinetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success.

Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4 years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30% MIP, which was increased by 10% daily; training was administered for five minutes, twice a day, seven times a week with supplemental oxygen for the entire period from the decision to wean up to extubation.

Description:

The sample for this investigation was selected in a randomized way in the period between December 2007 and November 2008. The individuals were successively entered in the research as they were admitted to the ICU, in respect of the criteria of inclusion and exclusion. From the total number of admitted patients in the period (n=67), many were excluded because they had been tracheostomized (n=25), were dead (n=13) or were transferred out of the hospital (n=1). Those that remained intubated (n=28) and went to the spontaneous mode were chosen randomly and in alternating fashion were divided into the experimental group (EG) or the control group (CG). The EG (n=14; age=82±4 years-old) underwent conventional physiotherapy plus inspiratory muscular training with threshold IMT® (Respironics/EUA - 2004), and the CG (n=14; age=81±6 years-old) received only conventional physiotherapy with no intervention that favored the inspiratory muscle strengthening.

As inclusion criteria, the individuals of the sample were required to have undergone MV for at least 48 hours in a controlled way13, as intubation is diagnostic for acute respiratory injury type 1 and has a maximum value of MIP of -20 cmH2O16.

Exclusion criteria included any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease17, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy). Tracheostomized patients (in the pre-test), those with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma), those with morbid obesity or those taking medicine that could cause a disorder of attention, as well as cases of auto-extubation, were also excluded.

The criteria of inclusion and exclusion were evaluated via examination of the patients' medical records and physical examination daily and in each session. The daily adherence of the patients to the necessary parameters for the study was noted for each patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• the individuals of the sample were required to have undergone Mechanical Ventilation for at least 48 hours in a controlled way

• intubation is diagnostic for acute respiratory injury type 1

• has a maximum value of MIP of -20 cmH2O16

Exclusion Criteria:

• any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy).

• Tracheostomized patients (in the pre-test).

• patients with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma.

• patients with morbid obesity

• patients taking medicine that could cause a disorder of attention.

• cases of auto-extubation.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Respiratory Aspiration
• Weaning

Intervention

Other:
• inspiratory muscle training
Protocol of inspiratory muscle training using threshold IMT®: After the MIP was measured, inspiratory muscle training was initiated. The Threshold-IMT® device of a linear pressure load produces a resistance to inspiration through the use of a flow-independent one-way valve. During expiration there is no resistance because the unidirectional valve opens, while during inspiration the valve closes, becoming "hard" due to the resistance of the spring. The suggested protocol was: initial load of 30% of the M24, increasing daily by 10%, with training for five minutes, twice a day, seven times a week in the period from the beginning of the weaning from the MV until the extubation of the patient. An essential factor was the use of supplemental oxygen (O2) as needed by the patient. The patients were in DD with fowler 45º.

Locations

Country	Name	City	State
Brazil	Quinta D'or Hospital	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Euro-American Network of Human Kinetics

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the MIP
Secondary	Measurement of rapid shallow breathing (IT)

External Links

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