Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation

NCT ID: NCT04731532

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2023-01-30

Brief Summary

Inclusion and Exclusion Criteria: Patients aged 18-65 years who are admitted to the investigator's 3rd Stage Intensive Care Unit and are dependent on mechanical ventilation will be included. The study was planned with 80 patients. Those with known chronic illnesses such as renal insufficiency, heart failure, liver failure, diabetes mellitus, hypertension, chronic obstructive pulmonary disease etc.,; patients in intensive care for postoperative follow-up; patients with mechanical ventilation due to chest or abdominal trauma will be excluded from the study.

Patients who meet the study criteria will be evaluated by a physiotherapy and rehabilitation specialist and will be decided to be included in the respiratory physiotherapy program. The patients will be treated by two physiotherapists in the intensive care unit at random. One of the physiotherapists will perform classical respiratory physiotherapy with thoracic vibration and the other will only perform classical respiratory physiotherapy.

Patients' acute physiology and chronic health assessment II (APACHE II) scores, partial oxygen pressure(PaO2) /fraction of inspired oxygen inspired oxygen fraction (FiO2), tidal volume, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels will be recorded daily. These values will be collected in the daily routine of the illness depending on the mechanical ventilation, by recording the already performed operations to follow the patient's clinic. If the duration of the total mechanical ventilation and complications occur, the type and timing of the complications will be examined.

At the end of the study, both physiotherapy methods, APACHE II scores, PaO2 / FiO2 values, tidal volume required, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels, mechanical ventilation duration and complications will be compared statistically.

Conditions

Pulmonary Medicine; Ventilators, Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Classical respiratory physiotherapy application

Patient positions, postural drainage application tapping and trifled

Group Type: ACTIVE_COMPARATOR

classical respiratory physiotherapy with thoracic vibration

Intervention Type: PROCEDURE

Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .

classical respiratory physiotherapy with thoracic vibration

Thoracic Vibration: The physiotherapist places his hands open with his / her fingers on the front and side walls of the patient's chest when the elbow is at 5-10 degrees of flexion. The elbow expands the patient's chest with vibrations. Exercise can be repeated 5-10 times a day+Patient positions, postural drainage application tapping and trifled

Group Type: ACTIVE_COMPARATOR

classical respiratory physiotherapy with thoracic vibration

Intervention Type: PROCEDURE

Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .

Interventions

classical respiratory physiotherapy with thoracic vibration

Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .

Intervention Type: PROCEDURE

Other Intervention Names

classical respiratory physiotherapy

Eligibility Criteria

Inclusion Criteria

• Patients who accepted for Step 3 Intensive Care Unit and connected to mechanical ventilation

Exclusion Criteria

• Patients with known chronic disease;
• Patients in intensive care for postoperative follow-up;
• Patients with mechanical ventilation due to chest or abdominal trauma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Seyhan Dülger,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seyhan Dülger

Bursa, Yıldırım, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Seyhan Dülger

Role: primary

drsdulger@gmail.com

05057482841

Related Links

http://doi.org/10.1016/j.aucc.2017.10.001

Related Info

Other Identifiers

2011-KAEK-25 2018/04-02

Identifier Type: -

Identifier Source: org_study_id