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

NCT ID: NCT05303623

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-12-25

Brief Summary

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

Detailed 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.

Conditions

Intensive Care Unit Acquired Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional Physiotherapy

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.

Group Type: EXPERIMENTAL

Conventional Physiotherapy

Intervention Type: OTHER

Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day.

Conventional Physiotherapy + inspiratory muscle training

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.

Group Type: EXPERIMENTAL

Conventional Physiotherapy+ inspiratory muscle training

Intervention Type: OTHER

Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. In this group addition to conventional physiotherapy inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.

Healthy Subject

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.

Group Type: EXPERIMENTAL

inspiratory muscle training

Intervention Type: OTHER

In this group inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.

Interventions

Conventional Physiotherapy

Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day.

Intervention Type: OTHER

Conventional Physiotherapy+ inspiratory muscle training

Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. In this group addition to conventional physiotherapy inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.

Intervention Type: OTHER

inspiratory muscle training

In this group inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Demiroglu Bilim University

OTHER

Sponsor Role: lead

Responsible Party

Reyhan Kaygusuz

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barış Yılmaz, Specialist

Role: STUDY_CHAIR

Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Locations

Istanbul Demiroglu University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

doctoral thesis

Identifier Type: -

Identifier Source: org_study_id