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Respiratory Muscle Training in ICU Patients

U

University of Liege

Status

Unknown

Conditions

Respiratory Muscle Training
Critical Illness
Inspiratory Muscle Strength
Mechanical Ventilation

Treatments

Procedure: inspiratory and expiratory exercises
Procedure: inspiratory and expiratory muscle training

Study type

Interventional

Funder types

Other

Identifiers

NCT04507451
RESP-USI

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Trained group
Experimental group
Description:
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
Treatment:
Procedure: inspiratory and expiratory muscle training
Untrained group
Placebo Comparator group
Description:
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
Treatment:
Procedure: inspiratory and expiratory exercises

Trial contacts and locations

1

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Central trial contact

Anne-Françoise Rousseau, MD, PhD

Data sourced from clinicaltrials.gov

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