Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of West Attica

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 volunteers

Qualifiers

≥ 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

Design model

Parallel

Treatments tested in this trial

  • IMT

    Other intervention

    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

  • Early mobilization

    Other intervention

    Protocolized early mobilization program

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: IMT GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weaning sucess

Successful weaning is defined as the removal of the endotracheal tube with no ventilator support for 48 hours following its removal

Time frame
immediately after intervention

Secondary outcomes

1

Weaning duration

Duration of weaning procedure

Time frame
immediately after intervention
2

Maximal Inspiratory Pressure

Maximal inspiratory Pressure

Time frame
1st day (baseline), immediately after intervention
3

Maximal expirartory pressure

Time frame
1st day (baseline), immediately after intervention

Other outcomes

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