Respiratory Muscle Training in ICU Patients

NCT04507451 | Unknown

• 1 other identifier: RESP-USI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Inspiratory Muscle Strength; Mechanical Ventilation; Respiratory Muscle Training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• change in expiratory muscle strength

  between 7 to 15 days after ICU discharge (compared to ICU discharge)

• change in expiratory muscle strength

  1 month after ICU discharge (compared to ICU discharge)

• respiratory infections

  1 month after ICU discharge

• change in dyspnea perception

  1 month after ICU discharge (compared to hospital discharge)

• impact of dyspnea on physical activities

  between 7 to 15 days after ICU discharge

Study Arms (2)

Trained group

EXPERIMENTAL

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

Untrained group

PLACEBO COMPARATOR

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

Interventions

inspiratory and expiratory muscle training PROCEDURE

inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water

Trained group

inspiratory and expiratory exercises PROCEDURE

inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level

Untrained group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Anne-Françoise Rousseau, MD, PhD

CONTACT

+3243667495; afrousseau@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients are masked: they will all benefit from respiratory physiotherapy, with placebo or real muscle training investigator and care providers are unmasked, as they set the training parameters
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: August 11, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)