Effect of Physiotherapy Methods on Functional and Respiratory Outcomes in ICU Patients With Respiratory Failure

Not Applicable

Active, not recruiting

• Conditions: Respiratory Insufficiency

• Registration Number: NCT06912308
• Lead Sponsor: Laura Rutkauskienė

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-30
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adults (≥18 years of age)
• Hospitalized in the Department of Reanimation and Intensive Therapy at LSMU Kaunas Clinics
• Diagnosis of respiratory failure (KFN) based on the following TLK-10-AM codes: J96.00, J96.01, J96.9, J96.10, J96.11, J96.19, J96.90, J96.91, J96.99
• Signed informed consent obtained from the patient or their legal representative

Exclusion Criteria

• Conscious patients who refuse to participate in the study
• Unconscious patients whose legal representative does not consent
• Recent episode of myocardial ischemia
• Pregnancy
• Heart rate < 40 bpm or > 130 bpm
• Mean arterial pressure < 60 mmHg or > 110 mmHg
• Oxygen saturation (SpO₂) ≤ 85%
• Body temperature ≥ 38.5°C or ≤ 36.0°C

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge	From Day 1 of ICU admission to ICU discharge (up to 50 days)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session	Immediately before and immediately after each physiotherapy session, up to 50 days during ICU stay	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.
Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay	From Day 1 of ICU admission to ICU discharge (up to 50 days)	Arterial blood gas analysis will be performed to monitor oxygenation. The following parameters will be recorded daily: arterial oxygen partial pressure (PaO₂, mmHg), inspired oxygen fraction (FiO₂), and their ratio (PaO₂/FiO₂). 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.
Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay	From Day 1 of physiotherapy to ICU discharge (up to 50 days)	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.

Trial Locations

Locations (1)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania