Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Dr. Franco Ravera Zunino

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Critically ill patients aged ≥ 18 years

Connected to mechanical ventilation

Secondary tracheostomy due to prolonged mechanical ventilation

Glasgow Coma Scale (GCS) > 11 points

Disqualifiers

Limitation of therapeutic effort (LTE*)

Pregnancy

Transfer to another center before completing the training (2 weeks)

Degenerative neuromuscular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory muscle training

    Other intervention

    Subjects will train only inspiratory muscle strength if they do not achieve VP or definitive disconnection of MV, and, when they already achieve these VP or definitive disconnection, the new EMI regimen that combines strength and resistance training will begin to be applied. Inspiratory muscle training guideline (EMI). On the day that, according to the EMI guideline, the Pimax evaluation corresponds, the training time will be replaced by the evaluation to avoid overloading the subjects with ventilatory work, training them only once a day.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximal inspiratory pressure

Maximum inspiratory pressure will be measured with the PowerBreathe valve before and after the training protocol to determine changes in diaphragm strength

Time frame
2 weeks

Secondary outcomes

1

Diaphragm thickness

Changes in diaphragm thickness will be assessed via ultrasound before and after the training protocol.

Time frame
2 weeks
2

Diaphragm excursion

Changes in diaphragm excursion will be assessed via ultrasound before and after the training protocol

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Dr. Franco Ravera Zunino

Lead sponsor

University of Chile

Collaborator