Comparison of the Effects of Inspiratory Muscle Training Methods in Mechanically Ventilated Patients

NCT ID: NCT06046690

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-11-15

Brief Summary

Inspiratory Muscle Training(IMT) increases the strength and endurance of the inspiratory muscles, exercise capacity, quality of life and reduces the perception of dyspnea. It has been reported in the literature that it also has an effect on mechanical ventilated patients in the intensive care unit. In patients on mechanical ventilation, IMT is applied with modification of trigger sensitivity and with an external device.

The aim of this study is to compare the effects of inspiratory muscle training with external device and MV modification on respiratory muscle strength and intubation time

Detailed Description

The intensive care unit (ICU) is the unit where patients with acute and life-threatening organ dysfunction or at risk are treated. Various technologies are used to support organ systems, especially the lungs, cardiovascular system, and kidneys. Mechanical ventilation (MV) device is the most important of these technologies. The device is clinically used in patients who need assistance to maintain adequate alveolar ventilation. Although MV is a life-saving intervention in respiratory failure, both short-term and longterm harmful consequences have been proven. Patients are weaned from mechanical ventilation when they begin to effective breathing on their own. However, he has persistent problems during his stay at the MV. Prolongation of the time spent on mechanical ventilation; It prolongs hospital stay and increases mortality and morbidity with many secondary pathologies ranging from pneumonia to polyneuropathy to delirium. As a result of all these, MV of the patient may cause reused. Physiotherapy is a very important component in the treatment of ICU patients, with both short-term and long-term advantages. Respiratory physiotherapy provides positive changes in hemodynamic and respiratory physiological parameters. Chest physiotherapy methods such as various chest manipulations, chest vibration and percussion, manual hyperinflation, postural drainage and various coughing techniques can be applied together or separately to prevent pulmonary complications in ICU patients. Techniques are used in mechanically ventilated patients to maintain airway clearance, reduce work of breathing, expand lungs, and prevent complications. Inspiratory muscle training (IMT), one of the respiratory physiotherapy applications used, is a technique used to increase the strength and endurance of the diaphragm and other accessory inspiratory muscles. In the ICU, inspiratory muscle training is achieved through devices that apply resistance or load to the inspiratory muscles, or through modification of the mechanical ventilator.

The aim of this study is to compare the effects of inspiratory muscle training with external device and MV modification on respiratory muscle strength and intubation time.

This prospective study will be conducted in Goztepe Prof. Dr. Suleyman Yalcın Cıty Hospıtal Hospital, Intensive Care Unit. Thirty-eight mechanically ventilated patients will be included in the study and randomly divided into two groups. In the MV group(MV-GR)(n=19), will be applied IMT with MV modification in addition to conventional physiotherapy, while in the external device group (E-GR) (n=19), IMT will be applied with an additional external device to conventional physiotherapy. P-FIT scale will be used for evaluation criteria, maximal inspiratory pressure, rapid shallow breathing index, oxygenation index, tidal volume, minute ventilation, weaning success values and functional status.

Conditions

Mechanical Ventilation; Intensive Care Units

Study Design

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

Study Groups

MV Modification Group

Participant in this group will be applied inspiratory muscle training with trigger system modification in addition to conventional chest physiotherapy consisting of respiratory control, diaphragmatic breathing, costal expansion exercises, postural drainage, effective coughing, in-bed ROM exercises and mobilization, twice a day until the day of extubation.

Group Type: EXPERIMENTAL

Mechanical Ventilation Device

Intervention Type: DEVICE

During the first week of training, ventilator trigger sensitivity will be initiated at 20% of the patient's baseline MIP (NIF). Patients will train for 5 minutes twice a day for the first days. As the training progresses, the triggering sensitivity will be gradually increased to 30% and 40% of the initial MIP and the duration will be increased up to 30 minutes. During the training sessions, participants will be elevated to a position similar to the Semi-Fowler position at an angle of approximately 45°. Vital signs will be monitored regularly.

In addition, conventional chest physiotherapy consisting of respiratory control, diaphragmatic breathing, costal expansion exercises, postural drainage, effective coughing, in-bed ROM exercises and mobilization will be applied twice daily.

External Device Group

Participant in this group will be applied inspiratory muscle training with Inspiratory Muscle Training (IMT) device in addition to conventional chest physiotherapy consisting of respiratory control, diaphragmatic breathing, costal expansion exercises, postural drainage, effective coughing, in-bed ROM exercises and mobilization, twice a day until the day of extubation.

Group Type: EXPERIMENTAL

External Device

Intervention Type: DEVICE

The IMT (Inspiratory Muscle Training) with device will commence at 20% of the value obtained from the NIF (Negative Inspiratory Force) measurement or the lowest pressure setting, depending on the patient's tolerance. The duration and intensity will be gradually increased. Once the participants are disconnected from the mechanical ventilator, the IMT device will be connected to the T-tube via a catheter mount with a Catheter Mount. Patients will be instructed to breathe against the resistance set on the IMT device. After completing 8 repetitions, the patient will be allowed to rest for a few minutes. This routine will be repeated for a total of 3 sets of 8 repetitions.

In addition, conventional chest physiotherapy consisting of respiratory control, diaphragmatic breathing, costal expansion exercises, postural drainage, effective coughing, in-bed ROM exercises and mobilization will be applied twice daily.

Interventions

Mechanical Ventilation Device

During the first week of training, ventilator trigger sensitivity will be initiated at 20% of the patient's baseline MIP (NIF). Patients will train for 5 minutes twice a day for the first days. As the training progresses, the triggering sensitivity will be gradually increased to 30% and 40% of the initial MIP and the duration will be increased up to 30 minutes. During the training sessions, participants will be elevated to a position similar to the Semi-Fowler position at an angle of approximately 45°. Vital signs will be monitored regularly.

In addition, conventional chest physiotherapy consisting of respiratory control, diaphragmatic breathing, costal expansion exercises, postural drainage, effective coughing, in-bed ROM exercises and mobilization will be applied twice daily.

Intervention Type: DEVICE

External Device

The IMT (Inspiratory Muscle Training) with device will commence at 20% of the value obtained from the NIF (Negative Inspiratory Force) measurement or the lowest pressure setting, depending on the patient's tolerance. The duration and intensity will be gradually increased. Once the participants are disconnected from the mechanical ventilator, the IMT device will be connected to the T-tube via a catheter mount with a Catheter Mount. Patients will be instructed to breathe against the resistance set on the IMT device. After completing 8 repetitions, the patient will be allowed to rest for a few minutes. This routine will be repeated for a total of 3 sets of 8 repetitions.

In addition, conventional chest physiotherapy consisting of respiratory control, diaphragmatic breathing, costal expansion exercises, postural drainage, effective coughing, in-bed ROM exercises and mobilization will be applied twice daily.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥18 years of age,
• Hemodynamically stable,
• Alert and conscious(Between -2 and +2 according to Richmond Agitation and Sedation Scale score)
• Perform at least one motor command,
• Requiring mechanical ventilation support either with continuous spontaneous ventilation(CPAP) mode or intermittent mandatory ventilation(SIMV) mode with pressure or volume control(PSV),
• Requiring oxygen ventilation ≤ 40%, Required pressure support ≤ 15 cmH2O, and PEEP ≤ 10 cmH2O,
• Having a body temperature between 36- 38 °C,
• Unable to breathe unsupported for 72 consecutive hours following the resolution of factors supporting respiratory failure,
• Having FiO2 ≤ 0.5, PaO2 > 60 mmHg, and capable of sufficient gas exchange,
• Patients deemed suitable for pulmonary physiotherapy by intensive care physicians will be included in the study.

Exclusion Criteria

• Having an acute onset of illness,
• Impaired cooperation,
• Insufficient level of consciousness due to severe intracranial disease ,
• Having a progressive neuromuscular disease,
• Having an unstable neurological condition,
• Having a psychiatric disorder and exhibiting excessive agitation (patients with Richmond Agitation and Sedation Scale (RASS) ≥ +2),
• Having experienced any trauma to the chest wall,
• Having thoracic deformities that affect respiration,
• Using a high amount of sedative or analgesic agents,
• Participants using home mechanical ventilators prior to hospital admission.

Criteria for Study Discontinuation:

• Cardiac, pulmonary, and other conditions leading to impaired hemodynamic stability.
• Impaired cooperation, compliance, and motivation.
• Discontinuation by the intensive care physician.
• Participants will be free to withdraw from the study at their discretion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital

OTHER

Sponsor Role: collaborator

SB Goztepe Prof Suleyman Yalcin City Hospital

UNKNOWN

Sponsor Role: collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Burak Uyaroğlu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Kocoglu, Prof.Dr.

Role: STUDY_CHAIR

Goztepe Prof Dr Suleyman Yalcın City Hospital

Esra Pehlivan, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Mehmet Burak Uyaroglu, PT,PhD(c)

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Locations

University of Health Sciences

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SaglikBilimleriUni

Identifier Type: -

Identifier Source: org_study_id