Respiratory Muscle Training in ICU Patients

Critical Illness Clinical Trial

Official title:

Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04507451
• Other study ID #: RESP-USI
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2020
• Source: University of Liege
• Contact: Anne-Françoise Rousseau, MD, PhD
• Phone: +3243667495
• Email: afrousseau[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient from mechanical ventilation after at least 24 hours of support
• collaborative patient

Exclusion Criteria:

• confusion, mental disorder
• not french speaking
• pulmonary surgery in the past 12 months
• external ventricular drain
• previous pneumothorax or pneumothorax not drained
• rib fractures
• alveolar hemorrhage
• hemodynamic instability
• labial occlusion impossible (face burn, facial paralysis)
• patient refusal

Related Conditions & MeSH terms

• Critical Illness
• Inspiratory Muscle Strength
• Mechanical Ventilation
• Respiratory Aspiration
• Respiratory Muscle Training

Intervention

Procedure:
• inspiratory and expiratory muscle training
inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water
• inspiratory and expiratory exercises
inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level

Locations

Country	Name	City	State
Belgium	University Hospital of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in inspiratory muscle strength	measurement of maximal inspiratory pressure	between 7 to 15 days after ICU discharge (compared to ICU discharge)
Primary	change in inspiratory muscle strength	measurement of maximal inspiratory pressure	1 month after ICU discharge (compared to ICU discharge)
Secondary	change in expiratory muscle strength	measurement of maximal expiratory pressure	between 7 to 15 days after ICU discharge (compared to ICU discharge)
Secondary	change in expiratory muscle strength	measurement of maximal expiratory pressure	1 month after ICU discharge (compared to ICU discharge)
Secondary	respiratory infections	number of respiratory infections requiring antibiotics after ICU discharge	1 month after ICU discharge
Secondary	change in dyspnea perception	assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)	1 month after ICU discharge (compared to hospital discharge)
Secondary	impact of dyspnea on physical activities	assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)	between 7 to 15 days after ICU discharge
Secondary	impact of dyspnea on physical activities	assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)	1 month after ICU discharge