Clinical trial NCT06912308: Effect of Physiotherapy Methods on Functional and Respiratory Outcomes in ICU Patients With Respiratory Failure
Official title: Changes in Functional and Qualitative Indicators of Critically Ill Patients With Respiratory Failure Using Different Physiotherapy Methods
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Lithuanian University of Health Sciences
First posted: 2025-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge
timeFrame: From Day 1 of ICU admission to ICU discharge (up to 50 days)
Secondary outcomes:
measure: Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay
timeFrame: From Day 1 of ICU admission to ICU discharge (up to 50 days)
measure: Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session
timeFrame: Immediately before and immediately after each physiotherapy session, up to 50 days during ICU stay
measure: Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay
timeFrame: From Day 1 of physiotherapy to ICU discharge (up to 50 days)
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
References: