N/A
N=126
Effects of Respiratory Muscle Training in Mechanically Ventilated Adults
Respiratory Muscle Weakness
Bottom Line
View on ClinicalTrials.gov: NCT02469064 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Weaning Time From Mechanical Ventilation — 5; 5 hours — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Respiratory muscle training (Other); Cardiopulmonary Physical Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundacion Clinica Valle del Lili
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weaning Time From Mechanical Ventilation |
5; 5 | 0.84 |
| SECONDARY Changes in Maximum Inspiratory Pressure (MIP) |
9.43; 5.92 | 0.48 |
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
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT02469064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.