Respiratory Muscle Training in ICU Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Mechanical Ventilation; Respiratory Muscle Training; Inspiratory Muscle Strength
• Intervention / Treatment: Procedure: inspiratory and expiratory muscle training; Procedure: inspiratory and expiratory exercises

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • University Hospital of Liege

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Trained group; Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week. Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge	Procedure: inspiratory and expiratory muscle training; inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water
PLACEBO_COMPARATOR: Untrained group; Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week. Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm) Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge	Procedure: inspiratory and expiratory exercises; inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in inspiratory muscle strength	measurement of maximal inspiratory pressure	between 7 to 15 days after ICU discharge (compared to ICU discharge)
change in inspiratory muscle strength	measurement of maximal inspiratory pressure	1 month after ICU discharge (compared to ICU discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in expiratory muscle strength	measurement of maximal expiratory pressure	between 7 to 15 days after ICU discharge (compared to ICU discharge)
change in expiratory muscle strength	measurement of maximal expiratory pressure	1 month after ICU discharge (compared to ICU discharge)
respiratory infections	number of respiratory infections requiring antibiotics after ICU discharge	1 month after ICU discharge
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)
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
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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: August 1, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Aspiration; Critical Illness
• Other Study ID Numbers: RESP-USI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No