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NCT Number: NCT06912308

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences

Kaunas, 49217, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Physiotherapy

Other

Involves patient-driven exercises such as verticalization, sitting on the edge of the bed, and active breathing exercises.

Passive Physiotherapy

Other

Employs methods like passive movements and electrostimulation of the diaphragm, providing therapeutic benefits without requiring active patient engagement.

Primary outcomes

  1. Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge

    Time frame: 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 outcomes

  1. Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay

    Time frame: 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.

  2. Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session

    Time frame: 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.

  3. Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Laura Rutkauskienė

Other

Collaborators

  • Lithuanian University of Health Sciences

Registry information

Official study title

Changes in Functional and Qualitative Indicators of Critically Ill Patients With Respiratory Failure Using Different Physiotherapy Methods

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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