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| Name | Class |
|---|---|
| Lithuanian University of Health Sciences | OTHER |
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The aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. By conducting this study and developing the "Physiotherapy Protocol for Critically Ill Patients Treated in the ICU," physiotherapists worldwide could be encouraged to work using a unified and adapted method.
It is expected that the results, conclusions, and practical clinical recommendations derived from this study will be beneficial not only for rehabilitation specialists and intensivists in Lithuania but also for medical professionals working with respiratory diseases, including COVID-19 patients, at various stages of their treatment and consultation.
Implementing an appropriate physiotherapy procedure protocol is anticipated to bring economic benefits, as early physiotherapy is safe and can reduce the incidence of delirium, decrease the duration of patient sedation, shorten the number of days on mechanical ventilation, and minimize hospital stay duration. Additionally, it aims to restore or improve patients' functional and independence levels, help prevent ICU-acquired weakness, and can be easily implemented in intensive care units.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Physiotherapy Intervention Arm (n=75) | Experimental | The subjects of one group will receive active physiotherapy (eg: verticalization, sitting on the edge of the bed, active breathing exercises). |
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| Passive Physiotherapy Intervention Arm (n=75) | Experimental | The other group will receive passive physiotherapy methods (eg: passive movements, electrostimulation of the diaphragm). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Physiotherapy | Other | Involves patient-driven exercises such as verticalization, sitting on the edge of the bed, and active breathing exercises. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge | Pulmonary function will be assessed using spirometry. The following parameters will be measured in liters and as percentages of predicted values: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1). Measurements will be taken on Day 1 (baseline) and at ICU discharge. The mean change in FVC and FEV1 will be calculated to assess respiratory improvement. | From Day 1 of ICU admission to ICU discharge (up to 50 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Arterial Oxygenation Parameters (PaOâ‚‚, FiOâ‚‚, and PaOâ‚‚/FiOâ‚‚ Ratio) During ICU Stay | Arterial blood gas analysis will be performed to monitor oxygenation. The following parameters will be recorded daily: arterial oxygen partial pressure (PaOâ‚‚, mmHg), inspired oxygen fraction (FiOâ‚‚), and their ratio (PaOâ‚‚/FiOâ‚‚). These values will be used to assess the progression of respiratory function and severity of respiratory failure. Mean changes from baseline to ICU discharge will be analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Kaunas | 49217 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41286729 | Derived | Rutkauskiene L, Kubilius R, Tamosuitis T. Early mobilization, breathing exercises and chest wall oscillation in patients with bilateral pneumonia disease in the intensive care unit: a randomized clinical trial. BMC Pulm Med. 2025 Nov 25;26(1):20. doi: 10.1186/s12890-025-04028-7. |
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For now, we do not have enough human and financial resources to share IPD, but if our circumstances change, we are open to reconsidering this decision.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Passive Physiotherapy | Other | Employs methods like passive movements and electrostimulation of the diaphragm, providing therapeutic benefits without requiring active patient engagement. |
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| From Day 1 of ICU admission to ICU discharge (up to 50 days) |
| Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session | Heart rate (beats per minute) and arterial blood pressure (systolic and diastolic, mmHg) will be measured immediately before and after each physiotherapy session to evaluate acute cardiovascular responses. Data will be recorded daily throughout the ICU stay (up to 50 days). Mean changes will be analyzed. | Immediately before and immediately after each physiotherapy session, up to 50 days during ICU stay |
| Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay | Patient mobility will be evaluated using the Intensive Care Unit Mobility Scale (ICUMS), which scores mobility from 0 (passive movements only) to 10 (independent ambulation). The scale will be administered at the beginning of each physiotherapy session. Mean score progression over time will be used to assess functional mobility changes. | From Day 1 of physiotherapy to ICU discharge (up to 50 days) |