Viewing Study NCT00922493



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Study NCT ID: NCT00922493
Status: COMPLETED
Last Update Posted: 2009-06-18
First Post: 2009-06-15

Brief Title: Inspiratory Muscle Training in Weaning
Sponsor: Euro-American Network of Human Kinetics
Organization: Euro-American Network of Human Kinetics

Study Overview

Official Title: Weaning Process in Elderly Intubated Patients Submitted to Inspiratory Muscle Training
Status: COMPLETED
Status Verified Date: 2009-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IMT
Brief 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 n14 age824 years that received conventional physiotherapy plus inspiratory muscle training IMT with threshold IMT and a control group CG n14 age816 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
Detailed 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 n67 many were excluded because they had been tracheostomized n25 were dead n13 or were transferred out of the hospital n1 Those that remained intubated n28 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 n14 age824 years-old underwent conventional physiotherapy plus inspiratory muscular training with threshold IMT RespironicsEUA - 2004 and the CG n14 age816 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None