Status:

UNKNOWN

Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?

Lead Sponsor:

Hospital Universitari Vall d'Hebron Research Institute

Conditions:

Weaning Failure

Eligibility:

All Genders

18-99 years

Phase:

NA

Brief Summary

Introduction: It has been described that invasive mechanical ventilation leads to diaphragm weakness. The inspiratory muscle weakness is related with a difficult and prolonged weaning as well as longe...

Eligibility Criteria

Inclusion

  • Medical patients aged ≥ 18 years hospitalized in the ICU.
  • Patients ventilated by tracheostomy and who have failed ≥ 1 spontaneous breathing test.
  • Being ventilated in assisted-controlled, assisted or pressure support modes.
  • PEEP ≤ 10 cmH2O
  • Richmond Agitation-Sedation Scale between -1 and 0.
  • Confusion Assessment Method for the Intensive Care Unit negative.
  • Cardiorespiratory and hemodynamic stability in the absence of vasopressor support or with minimal requirement (dobutamine or dopamine ≤ 5 μg / kg / min, phenylephrine ≤ 1 μg / kg / min).
  • FiO2 ≤ 0,6
  • PaO2/FiO2 ratio \> 200
  • Blood lactate levels \< 4 mmol/L

Exclusion

  • Progressive neuromuscular disease
  • Thoraco-abdominal surgery in a period \<30 days from the beginning of the study.
  • Diseases that cause hemodynamic instability (cardiac arrhythmia, decompensated heart failure, unstable ischemic heart disease).
  • Hemoptysis
  • Unstable chest wall.
  • Not drained pneumothorax
  • Phrenic nerve injury
  • Spinal cord injury above T8
  • Clinical signs of respiratory distress (paradoxal breathing, use of accessory respiratory muscles)
  • Body mass index \> 40 kg / m2
  • Use domiciliary ventilator support prior to hospitalization.
  • Skeletal disorder of the rib cage that impairs its biomechanics (severe kyphoscoliosis, congenital deformities).
  • Body temperature \> 38ºC
  • Pregnancy
  • Receive therapy with nitric oxide or nebulized prostacyclin.
  • Medical order.

Key Trial Info

Start Date :

June 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2021

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04347317

Start Date

June 1 2021

End Date

December 31 2021

Last Update

April 19 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Hospital Universitari Vall d'Hebron Research Institute

Barcelona, Spain, 08035

2

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035