Clinical trial NCT06046690: Comparison of the Effects of Inspiratory Muscle Training Methods in Mechanically Ventilated Patients
Official title: Comparison of the Effects of Inspiratory Muscle Training with Trigger System Modification and External Device in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Intensive Care Units
Keywords: İnspiratory muscle training
intensive care
rehabilitation
mechanical ventilation
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Goztepe Prof Dr Suleyman Yalcın City Hospital
name: SB Goztepe Prof Suleyman Yalcin City Hospital
First posted: 2023-09-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assesment of respiratory muscle strength
timeFrame: It will be measured before training and before extubation.
measure: Assesment of lung volume assessment
timeFrame: Measurements will be taken before and after daily exercises from the start of education until the day of extubation, an average 10 days
measure: Assesment of the respiratory status
timeFrame: It will be measured before training and before extubation.
measure: Assesment of the oxygenation status
timeFrame: It will be measured before training and before extubation.
measure: Assesment of physical status
timeFrame: It will be measured before training and before extubation.
measure: Assesment of Mechanical ventilator parameters
timeFrame: Measurements will be taken before and after daily exercises from the start of education until the day of extubation, an average 10 days
measure: Assesment of Partial Pressure of Oxygen(PaO2) and Partial Pressure of Carbon dioxide(PaCO2) in Arterial Blood
timeFrame: Measurements will be taken before and after daily exercises from the start of education until the day of extubation, an average 10 days
measure: Assesment Concentration of Bicarbonate(HCO3) in Arterial Blood
timeFrame: Measurements will be taken before and after daily exercises from the start of education until the day of extubation, an average 10 days
measure: Assesment pH values
timeFrame: Measurements will be taken before and after daily exercises from the start of education until the day of extubation, an average 10 days
measure: Assesment of Minute Ventilation
timeFrame: Measurements will be taken before and after daily exercises from the start of education until the day of extubation, an average 10 days
measure: Assesment Fraction of Inspired Oxygen(FiO2)
timeFrame: Measurements will be taken before and after daily exercises from the start of education until the day of extubation, an average 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Goztepe Prof Dr Suleyman Yalcın City Hospital
name: Hasan Kocoglu, Prof.Dr.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Esra Pehlivan, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Mehmet Burak Uyaroglu, PT,PhD(c)
role: STUDY_CHAIR
References: