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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1
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, Spain, 08035
2
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035