The Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients

Istanbul Demiroglu Bilim University

Status: Completed

Conditions: Intensive Care Unit Acquired Weakness

Treatments: Other: inspiratory muscle training; Other: Conventional Physiotherapy; Other: Conventional Physiotherapy+ inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT05303623

doctoral thesis

Details and patient eligibility

About

In this study, the effect of inspiratory muscle training on diaphragmatic functions will be investigated radiologically in mechanically ventilated patients.

Full description

Many patients who receive treatment in intensive care need mechanical ventilation support. Invasive mechanical ventilation is an application used in critically ill patients to provide pulmonary gas exchange and to relieve the respiratory muscles. Mechanical ventilation and long- term bed rest induced extremity muscle weakness is a common condition in patients hospitalized in the intensive care unit. Acquired muscle weakness in intensive care is associated with poor prognosis and high mortality At the same time, mechanical ventilation can lead to the development of respiratory muscle dystrophy and atrophy.

Recently, a similar concern has arisen about the potential negative effects of mechanical ventilation on respiratory muscles. This condition is called ventilator-induced diaphragmatic dysfunction In patients with mechanical ventilation, dysfunction, muscle fiber type change and barotrauma are seen especially in the diaphragm, which is the primary inspiratory muscle. Diaphragmatic dysfunction may promote prolong of intubation, weaning difficulties and risk of increase reintubation in patients who are mechanically ventilated.

The effect of inspiratory muscle training, which is applied in addition to conventional respiratory physiotherapy, on diaphragmatic dysfunction, on the weaning process and the long of stay in intensive care has not been fully elucidated, and a limited number of studies have been conducted on this subject It has been reported that in patients with prolonged mechanical ventilation, diaphragmatic peak contraction velocity, peak relaxation velocity, movement speed, velocity time integral are lower than healthy individuals and this is correlated with failure to wean from mechanical ventilation. We could not find any report and clinical trial in the literature evaluation the effect of conventional physiotherapy and additional inspiratory muscle training on diaphragmatic tissue movement velocity and diaphragm thickness using detailed radiological methods in intensive care patients dependent on mechanical ventilation. In this context, our not working has a unique value. Our study will contribute to elucidating the mechanisms that affect the weaning process from mechanical ventilation in intensive care patients. It is aimed to develop strategies that will shorten the long of stay in intensive care and total hospital stay with therapeutic approaches that enable patients to be extubated as early as possible.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For Patients Group Inclusion Criteria:

• Needing mechanical ventilation support longer than 2 days,
• Alert and Riker Sedation Agitation Score >4
• Being hemodynamically stable (HR<140 beats/min, BP stable)
• Dobutamine and minimal vasopressor use
• Fever of 36.5-38.5
• Body Mass Index <40 m2/cm,
• FiO2 of 0.5 or less,
• Absence of myocardial ischemia.

For Patients Group Exclusion Criteria:

• Noncooperation
• Phrenic nerve damage
• Chest wall trauma and/or deformity to prevent diaphragmatic movement
• Progressive neuromuscular disease with respiratory involvement
• There is enough secretion to require more than one aspiration every hour.
• Patients using sedative drugs continuously
• High-dose cortisol use
• Using a home mechanical ventilator before mechanical ventilation in intensive care unit

For Healthy Group Inclusion Criteria:

• With the control and intervention group, age, characteristics and characteristics,
• Chronic system and no ongoing treatment,
• Body mass index not 40 kg/m2,
• 18-80 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Conventional Physiotherapy

Experimental group

Description:

In the intensive care unit and who had mechanical ventilation for more than 48 hours and who were extubated. Medical, physical and respiratory examination in this group Physical Function Test in Intensive Care (PFIT), maximum inspiratory mouth pressure and maximum expiratory mouth pressure, Medical Research Council Muscle Strength Test and diaphragmatic function with B mode and M mode ultrasonographic assessment. In this group will apply only conventional physiotherapy. Conventional physiotherapy to contain breathing and,thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization. Conventional physiotherapy apply for 5 days after extubation period 1 time a day.

Treatment:

Other: Conventional Physiotherapy

Conventional Physiotherapy + inspiratory muscle training

Experimental group

Description:

Physical ,medical and respiratory examination in this group Physical Function Test in Intensive Care (PFIT), maximum inspiratory mouth pressure and maximum expiratory mouth pressure, Medical Research Council Muscle Strength Test and diaphragmatic function with B mode and M mode ultrasonographic assessment. In this group, inspiratory muscle training will be applied in addition to conventional physiotherapy. Inspiratory muscle training apply for 5 days after extubation period. Inspiratory muscle training will be given with a threshold loading by giving resistance at 30-40% of the maximum inspiratory pressure measurement obtained. The subjects in this group will be given inspiratory muscle training 4 sets with 6-10 breaths per set, 1-2 minutes between each set once a day in addition to conventional physiotherapy.

Treatment:

Other: Conventional Physiotherapy+ inspiratory muscle training

Healthy Subject

Experimental group

Description:

In the group consisting of healthy volunteers, which will be taken to determine the normative values of the outcome measurements for diaphragmatic tissue Doppler imaging and ultrasonographic evaluation, 2 sessions a day with a threshold-loaded inspiratory muscle training device, starting at 30% of the MIP value, 5 days a week for 4 weeks. Inspiratory muscle training will be performed in 4 sets, 6-8 breaths in each set and 2 minutes rest between sets. In the second evaluation to be made after the inspiratory muscle training, the above-mentioned evaluations and measurements will be repeated.

Treatment:

Other: inspiratory muscle training