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Effects of Respiratory Muscle Training in Mechanically Ventilated Adults (RMTMVA)

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ClinicalTrials.gov Identifier: NCT02469064
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Universidad del Valle, Colombia
Fundacion Clinica Valle del Lili
Information provided by (Responsible Party):
Lina Sandoval, Fundacion Clinica Valle del Lili

Brief Summary:
Respiratory muscle training (RMT) is considered a therapeutic strategy to improve respiratory muscle strength in mechanically ventilated (MV) patients and facilitates ventilator weaning. RMT aims at improving strength and endurance of respiratory muscles . However, scarce research exists regarding evaluation of RMT in MV patients and additionally studies differ in methods, RMT protocols and subjects included. There are not reports about Colombian studies evaluating RMT effects on MV patients. The aim of this study is to evaluate the effectiveness of respiratory muscle training in increasing respiratory muscle strength and improving weaning outcomes in MV patients who required ventilatory support for more than 48 hours at an Intensive Care Unit of an IV level Hospital in Cali during the period 2014-2015

Condition or disease Intervention/treatment Phase
Respiratory Muscle Weakness Other: Respiratory muscle training Other: Cardiopulmonary Physical Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Respiratory Muscle Training in Mechanically Ventilated Adults
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Respiratory Muscle Training
Experimental group receives as additional treatment respiratory muscle training.
Other: Respiratory muscle training
Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients.

Other: Cardiopulmonary Physical Therapy
Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management

Active Comparator: Conventional physical therapy
Conventional Cardiopulmonary Physical Therapy
Other: Cardiopulmonary Physical Therapy
Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management




Primary Outcome Measures :
  1. Weaning Time From Mechanical Ventilation [ Time Frame: Measured by the end of the period of mechanical ventilation, an average expected time of 4 days ]
    Weaning time was considered as time elapsed from beginning of pressure support mode in mechanical ventilation (Pressure support at 10 centimeters of water (cmsH2O) or less) or continuous positive pressure in the airway mode (CPAP) until patient extubation


Secondary Outcome Measures :
  1. Changes in Maximum Inspiratory Pressure (MIP) [ Time Frame: Measured at baseline (baseline MIP) and right before patient extubation (finalMIP, an average of 2 hours) ]
    Changes in Maximum Inspiratory Pressure (MIP) was considered as Final MIP minus baseline MIP



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

Inclusion Criteria:

  • Age 18 years at least
  • Informed consent to participate in study by legal representative or family member
  • First event requiring mechanical ventilation
  • Being intubated at the study setting ( Valle del Lili Foundation) or at peripheral services and referred 12 hours or less after intubation
  • Adequate gas interchange: Blood pressure of oxygen > 60 mmHg with Inspired fraction of oxygen ≤ 0. 5 and positive pressure at end of expiration (PEEP) < 8 cmh20
  • Sedation level between -1 and 0 (24, 25)
  • Hemodynamic stability: Medium arterial blood pressure > 60 mmHg without vasopressors or requiring a minimum of vasopressor support (epinephrine < 0,4 mcg/Kg/ min)

Exclusion Criteria:

  • Progressive neuromuscular disease such as Amyotrophic Lateral Sclerosis , Muscular Dystrophy, Multiple Sclerosis, Myasthenia Gravis, or other neuromuscular disorder that could interfere with response to inspiratory muscle training .
  • Central nervous system disorders: severe traumatic brain injury
  • Spinal cord injury at a level higher than T8
  • Chest or spine skeletal disorders (scoliosis, flail chest, spine surgery) that limit movement of ribs and rib cage.
  • Requirement of ventilatory support at home prior to hospitalization
  • Presence of excessive secretions (requiring more than one suctioning procedure every hour).
  • Tracheostomy
  • Previous requirement of mechanical ventilation during this period of hospitalization
  • Pregnancy

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): NCT02469064


Sponsors and Collaborators
Lina Sandoval
Universidad del Valle, Colombia
Fundacion Clinica Valle del Lili
Investigators
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Principal Investigator: Lina M Sandoval, PT Fundacion Valle del Lili- Universidad del Valle
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lina Sandoval, Physical Therapist, Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier: NCT02469064    
Other Study ID Numbers: 1755
First Posted: June 11, 2015    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lina Sandoval, Fundacion Clinica Valle del Lili:
mechanical ventilation
respiratory muscle
weaning
training
Intensive care
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes