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Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients

Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07613021
Acronym
IMT in weaning
Enrollment
45
Registered
2026-05-29
Start date
2026-04-01
Completion date
2029-12-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Ventilated ICU Patients

Keywords

Inspiratory Muscle training, Weaning, Maximal Inspiratory pressure, Intensive Care Unit

Brief summary

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.

Detailed description

It is estimated that 40% of the duration of mechanical ventilation is devoted to the weaning process. A length of stay in the ICU of more than 7 days appears to be associated with a 27,9% risk of developing infections. Furthermore, the mortality rate is higher in patients with infections. Additionally, the daily cost of hospitalizing a patient on mechanical ventilation is estimated at €1,590-€1,657, while this varies depending on the interventions required. The burden on the National Health System from the prolonged stay of patients in the ICU, as well as from the complications that will arise, increases exponentially. It has been found that implementing an IMT program can lead to rapid and successful extubation of the patient, while early mobilization can accelerate timely discharge from the ICU. This optimizes the cost-effectiveness ratio in intensive care units. The investigators believe that implementing an IMT program will maximize the effectiveness of the early mobilization program for ICU patients. Thus, the investigators believe it will provide valuable insights into the rehabilitation needs of critically ill patients, contributing to earlier weaning from mechanical ventilation and transition to the next level of care. The investigators hypothesize that the implementation of such an intervention program will reduce the length of hospital stay, while also lowering the cost of daily care. This is a randomized control trial that investigates the effectiveness of an inspiratory muscle training program in successful weaning of mechanically ventilated patients for at least 72 hours. Both experimental groups will receive a protocolised early mobilization program. IMT intervention will be applied till ICU discharge once a day for 5 days/week initiating with a load of 40% of maximal inspiratory pressure (MIP). Primary outcome will be a successful weaning from MV. And secondary includes MV duration, MIP, maximal expiratory pressure (MEP), ICU and hopsital length of stay.

Interventions

OTHERIMT

Inspiratory 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

OTHEREarly mobilization

Protocolized early mobilization program

Sponsors

University of West Attica
Lead SponsorOTHER
General Hospital of Chalkida
CollaboratorOTHER_GOV
General Hospital of Nikaia "Saint Panteleimon"
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Randomized Control Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 72h invasive mechanical ventilation * adequate co-operativeness as assessed by 5SQ ≥ 3.

Exclusion criteria

* terminal condition or palliative care * neuromuscular or neurological conditions prior to ICU admission

Design outcomes

Primary

MeasureTime frameDescription
Weaning sucessimmediately after interventionSuccessful weaning is defined as the removal of the endotracheal tube with no ventilator support for 48 hours following its removal

Secondary

MeasureTime frameDescription
Weaning durationimmediately after interventionDuration of weaning procedure
Maximal Inspiratory Pressure1st day (baseline), immediately after interventionMaximal inspiratory Pressure
Maximal expirartory pressure1st day (baseline), immediately after intervention

Countries

Greece

Contacts

CONTACTIRINI PATSAKI, PhD
ipatsaki@uniwa.gr+30 6942064363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026