NCT00922493

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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

First QC Date

June 15, 2009

Last Update Submit

June 17, 2009

Conditions

Keywords

weaninginspiratory muscle trainingmaximum inspiratory pressure (MIP)index of Tobin (IT)intubatedintensive care unitelderly

Outcome Measures

Primary Outcomes (1)

  • Measurement of the MIP

Secondary Outcomes (1)

  • Measurement of rapid shallow breathing (IT)

Interventions

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.

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quinta D'or Hospital

Rio de Janeiro, Rio de Janeiro, 22790-140, Brazil

Location

Related Publications (1)

  • Cader SA, Vale RG, Castro JC, Bacelar SC, Biehl C, Gomes MC, Cabrer WE, Dantas EH. Inspiratory muscle training improves maximal inspiratory pressure and may assist weaning in older intubated patients: a randomised trial. J Physiother. 2010;56(3):171-7. doi: 10.1016/s1836-9553(10)70022-9.

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

December 1, 2007

Study Completion

November 1, 2008

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations