NCT06684392 Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects
| NCT ID | NCT06684392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Dr. Franco Ravera Zunino |
| Condition | Tracheostomy Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2023-11-01 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be assessed: an experimental group, who will follow an individualized inspiratory muscle training regimen for 14 days along with standard physiotherapy, and a control group, who will receive standard physiotherapy and guided weaning through scheduled disconnection windows from mechanical ventilation. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The results of this study will help optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and the patients, and improving their quality of life, contributing to some health objectives for the 2011-2020 decade.
Eligibility Criteria
Inclusion Criteria: * Critically ill patients aged ≥ 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 Exclusion Criteria: * 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 \[IC\]).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06684392 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tracheostomy Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06684392 currently recruiting?
Yes, NCT06684392 is actively recruiting participants. Contact the research team at jenniferayuso@gmail.com for enrollment information.
Where is the NCT06684392 trial being conducted?
This trial is being conducted at Rancagua, Chile.
Who is sponsoring the NCT06684392 clinical trial?
NCT06684392 is sponsored by Hospital Dr. Franco Ravera Zunino. The trial plans to enroll 56 participants.