Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients

NCT07613021 | Recruiting

• 1 other identifier: 77916
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Mechanically Ventilated ICU Patients

Keywords

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

Outcome Measures

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

  immediately after intervention

Secondary Outcomes (3)

• Weaning duration

  immediately after intervention

• Maximal Inspiratory Pressure

  1st day (baseline), immediately after intervention

• Maximal expirartory pressure

  1st day (baseline), immediately after intervention

Study Arms (2)

IMT Group

EXPERIMENTAL

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. Additional, a protocolized early mobilization program will be perfromed.

Other: IMT; Other: Early mobilization

Control Group

ACTIVE COMPARATOR

A protocolized early mobilization program

Other: Early mobilization

Interventions

IMT OTHER

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

IMT Group

Early mobilization OTHER

Protocolized early mobilization program

Control Group; IMT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of West Attica: lead
• General Hospital of Chalkida: collaborator
• General Hospital of Nikaia "Saint Panteleimon": collaborator

Study Sites (2)

General Hospital

Chalcis, Greece

RECRUITING

General Hospital "Agios Panteleimon"

Nikaia, Greece

RECRUITING

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

IRINI PATSAKI, PhD

CONTACT

+30 6942064363; ipatsaki@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)