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Inspiratory Muscle Training in Difficult to Wean Patients

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ClinicalTrials.gov Identifier: NCT03240263
Recruitment Status : Not yet recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Langer, KU Leuven

Brief Summary:
Failure to wean is a clinical problem and strength training of inspiratory muscles has been recently proposed as possible additional component of weaning strategies. The main hypothesis is that inspiratory muscle training improve weaning success rates and abbreviate weaning duration and ICU length of stay in difficult to wean patients compared to a sham endurance training group.

Condition or disease Intervention/treatment Phase
Difficult to Wean Patients Procedure: Inspiratory Muscle Training Procedure: Endurance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

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 treatment: 28 days ]
    Successful separation attempt without reintubation or reconnection to the MV



Information from the National Library of Medicine

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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
  • 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
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Rik Gosselink, PT, PhD KU Leuven

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: August 7, 2017
Last Verified: August 2017

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