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Inspiratory Muscle Training in Difficult to Wean Patients

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ClinicalTrials.gov Identifier: NCT03240263
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Langer, KU Leuven

Brief Summary:
Prolonged mechanical ventilation secondary to weaning failure demands a significant amount of intensive care unit (ICU) resources, thus increasing the economic burden of public healthcare costs. One of the proposed mechanisms accounting for weaning failure is the concept that excessive work of breathing for weak respiratory muscles during the liberation from mechanical ventilation compromises cerebral blood flow, thereby predisposing the brain to dysfunction. Restriction in brain perfusion could have an adverse impact on the function of the respiratory muscles by impairing the output of the respiratory centre thus promoting respiratory muscle fatigue, leading to weaning failure. Inspiratory muscle training (IMT) has been shown to improve the functional capacity of the inspiratory muscles in patients with respiratory muscle weakness whilst has been recently proposed as a possible additional component of weaning strategies. Therefore, this project aims to identify both a mechanism that might be linked to prolong ICU length of stay and that at the same time might be amenable to treatment.

Condition or disease Intervention/treatment Phase
Weaning Failure Procedure: Inspiratory Muscle Training Procedure: Endurance training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training in Difficult to Wean Patients: a Randomised Controlled Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
Experimental: Inspiratory muscle training
High intensity inspiratory muscle training
Procedure: Inspiratory Muscle Training

Supervised daily sessions of training including 4 sets of 6-10 breaths using a tapared flow resistive load device*. Resistance adjusted to the highest tolerable load.

*Electronic Variable Flow Resistive Loading IMT Device/ POWERbreathe®KH1, HaB International Ltd., Southam, UK


Sham Comparator: Sham endurance training
Sham inspiratory muscle training at low intensity
Procedure: Endurance training

Supervised daily sessions of training including 4 sets of 6-10 breaths using a tapared flow resistive load device*. Low training resistance adjusted to <10% maximal inspiratory pressure.

*Electronic Variable Flow Resistive Loading IMT Device/ POWERbreathe®KH1, HaB International Ltd., Southam, UK





Primary Outcome Measures :
  1. Weaning Success [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    Successful separation attempt without reintubation or reconnection to the MV

  2. Inspiratory muscles and cerebral cortex blood flow index ([BFI] measured in nanomoles per second, [minimum and maximum scores 0 to 100 nanomoles per second]) [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    Measured with Near Infrared Spectroscopy

  3. Inspiratory muscles and cerebral cortex fractional oxygen availability (StiO2% measured as a percentage [minimum and maximum scores 0 to 100 %]) [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    Measured with Near Infrared Spectroscopy


Secondary Outcome Measures :
  1. Length of stay in the ICU [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    (days)

  2. Duration of mechanical ventilation [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    days since patient was connected to mechanical ventilator

  3. rapid shallow breathing index after 2 hours of successful SBT [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    (Breaths/minute/liters)

  4. Vital Capacity [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    (L)

  5. MIP [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    (cmH2O)

  6. ventilator-free days [ Time Frame: Maximal duration of IMT treatment: 28 days ]
    days free from the mechanical ventilation



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Difficult and prolonged weaning patients
  • Simple weaning patients
  • Adequate oxygenation
  • Febrile temperature < 38ºC
  • Hemodynamic stability
  • Stable blood pressure
  • No or minimal pressors
  • No myocardial ischemia
  • Adequate hemoglobin and mentation
  • Resolution of disease acute phase
  • Able to follow simple verbal commands related to IMT
  • Mechanically ventilated via a tracheostomy or endotracheal tube

Exclusion Criteria:

  • Pre-existing neuromuscular disease
  • Agitation
  • Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency)
  • Hemoptysis
  • Diaphoresis
  • Spinal cord injury above T8
  • Use of any type of home MV support prior to hospitalization
  • Skeletal pathology that impairs chest wall movements
  • Poor general prognosis or fatal outcome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240263


Contacts
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Contact: Daniel Langer, PT, PhD 032-16-330192 daniel.langer@faber.kuleuven.be

Locations
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Belgium
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Sub-Investigator: Daniel Langer, PT,PhD         
Principal Investigator: Rik Gosselink, PT, PhD         
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Rik Gosselink, PT, PhD KU Leuven

Additional Information:
Publications:
Louvaris Z, Vogiatzis I. Respiratory muscle blood flow measured by Near-Infrared Spectroscopy (NIRS) by indocyanine green dye. In: Aliverti A PA, ed. Mechanics of breathing. Italy: Springler-Verlag, 169-178, 2014.
Riley RL. The work of breathing and its relation to respiratory acidosis. Annals of Internal Medicine 41:172-176, 1954

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Langer, PT, PhD, KU Leuven
ClinicalTrials.gov Identifier: NCT03240263     History of Changes
Other Study ID Numbers: S60516
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Langer, KU Leuven:
Difficult to wean patients
ICU aquired muscle weakness
Cerebral perfusion
Respiratroy muscles
IMT
Cerebral oxygenation
Weaning outcomes

Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes