About this trial
Patients in critical condition, due to their prolonged stay in the Intensive Care Unit (ICU), the severity of the underlying disease, and potential adverse effects of hospitalization, may develop serious complications, such as muscle atrophy and weakness, which also affect the respiratory muscles. It is characteristic that within the first 18-69 hours of mechanical ventilation (MV), proteolytic processes occur that lead to rapid atrophy of the diaphragm. Diaphragmatic dysfunction acquired during the ICU stay thus appears to have an adverse effect on weaning from mechanical ventilation, length of ICU stay, length of hospital stay, functional status, quality of life, and mortality within the ICU and the hospital. Inspiratory muscle training (IMT) has been identified as an intervention that could augment weaning, preventing the dedtrimental effects of MV. The purpose of this study is to assess the effect of an IMT protocol in weaning success of ICU patients. Specifically, an electronic device will be used that incorporates a tapered flow resistive technique.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 72h invasive mechanical ventilation
adequate co-operativeness as assessed by 5SQ ≥ 3.
Disqualifiers
terminal condition or palliative care
neuromuscular or neurological conditions prior to ICU admission
Trial design
Parallel
Treatments tested in this trial
IMT
Other interventionInspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets
Early mobilization
Other interventionProtocolized early mobilization program
Treatment groups
Trial outcomes
Primary outcomes
Weaning sucess
Successful weaning is defined as the removal of the endotracheal tube with no ventilator support for 48 hours following its removal
Secondary outcomes
Weaning duration
Duration of weaning procedure
Maximal Inspiratory Pressure
Maximal inspiratory Pressure
Maximal expirartory pressure
Sponsors and contacts
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University of West Attica
Lead sponsor
General Hospital of Chalkida
Collaborator
General Hospital of Nikaia "Saint Panteleimon"
Collaborator