Actively Recruiting
Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation
Led by Hospital Dr. Franco Ravera Zunino · Updated on 2024-11-12
56
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
H
Hospital Dr. Franco Ravera Zunino
Lead Sponsor
U
University of Chile
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a personalized inspiratory muscle training program on patients with tracheostomy due to prolonged mechanical ventilation. It focuses on improving maximum inspiratory pressure, diaphragm thickness fraction, and shortening the time needed to remove the tracheostomy tube. The study compares two groups of adult patients: one receiving this special muscle training combined with standard physiotherapy, and a control group receiving only standard physiotherapy with guided weaning from mechanical ventilation. The goal is to optimize patient care, reduce hospital stays and costs, and enhance quality of life. Participants in the experimental group will follow an individualized inspiratory muscle training program combining strength and endurance exercises for 14 days alongside standard physiotherapy. The control group will follow the usual weaning protocol, starting with shorter mechanical ventilation disconnection periods and gradually increasing them, plus training at 50% of their maximum inspiratory pressure after weaning. The intervention adjusts training based on patients’ respiratory status, with evaluations replacing training sessions as needed to avoid overexertion. During the study, patients will be monitored for respiratory muscle strength, diaphragm thickness, and diaphragm movement over two weeks. Researchers will also track the time to successful decannulation, length of ICU and hospital stays, and quality of life through surveys. Safety criteria include suspending training if patients show signs of respiratory distress. Overall participation lasts at least two weeks, with ongoing assessments to measure treatment impact and patient progress.
CONDITIONS
Brief Title
Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Critically ill patients aged 60; 18 years
- Connected to mechanical ventilation
- Secondary tracheostomy due to prolonged mechanical ventilation
- Glasgow Coma Scale (GCS) > 11 points
- Level of cooperation score (S5Q) > 3 points
You will not qualify if you...
- Limitation of therapeutic effort (LTE*)
- Pregnancy
- Transfer to another center before completing the training (2 weeks)
- Degenerative neuromuscular disease
- Refusal to participate in this study (declining to provide informed consent [IC])
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks
Participants undergo inspiratory muscle training combining strength and endurance exercises for two weeks, in addition to standard physiotherapy and weaning protocols.
Daily training sessions with scheduled evaluations replacing training on some days to avoid excessive workload
Trial Site Locations
Total: 1 location
1
Hospital Regional Franco Ravera Zunino
Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
Actively Recruiting
Research Team
K
Kinesióloga Jennifer Ayuso, Master of science
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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