Respiratory Muscle Training in ICU Patients

NCT ID: NCT04507451

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness Inspiratory Muscle Strength Mechanical Ventilation Respiratory Muscle Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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

Study Groups

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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

Group Type EXPERIMENTAL

inspiratory and expiratory muscle training

Intervention Type PROCEDURE

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

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

Group Type PLACEBO_COMPARATOR

inspiratory and expiratory exercises

Intervention Type PROCEDURE

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

Interventions

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inspiratory and expiratory muscle training

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

Intervention Type PROCEDURE

inspiratory and expiratory exercises

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Rousseau

Head of clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Liège

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Anne-Françoise Rousseau, MD, PhD

Role: CONTACT

+3243667495

Facility Contacts

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Anne-Françoise Rousseau, PhD

Role: primary

+3243667495

Other Identifiers

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RESP-USI

Identifier Type: -

Identifier Source: org_study_id