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

Laura Rutkauskienė

Status: Active, not recruiting

Conditions: Respiratory Insufficiency

Treatments: Other: Passive Physiotherapy; Other: Active Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06912308

Protocol number 1 • Version 3

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Active Physiotherapy Intervention Arm (n=75)

Experimental group

Description:

The subjects of one group will receive active physiotherapy (eg: verticalization, sitting on the edge of the bed, active breathing exercises).

Treatment:

Other: Active Physiotherapy

Passive Physiotherapy Intervention Arm (n=75)

Experimental group

Description:

The other group will receive passive physiotherapy methods (eg: passive movements, electrostimulation of the diaphragm).

Treatment:

Other: Passive Physiotherapy