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

University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilators, Mechanical; Pulmonary Medicine
• Intervention / Treatment: Procedure: classical respiratory physiotherapy with thoracic vibration

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yıldırım
    • Bursa, Yıldırım, Turkey, 16115
      • Recruiting
      • Seyhan Dülger
      • Contact: Seyhan Dülger; Phone Number: 05057482841; Email: drsdulger@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Classical respiratory physiotherapy application; Patient positions, postural drainage application tapping and trifled	Procedure: classical respiratory physiotherapy with thoracic vibration; Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .; Other Names: classical respiratory physiotherapy
Active Comparator: 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	Procedure: classical respiratory physiotherapy with thoracic vibration; Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .; Other Names: classical respiratory physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of patient waking from the mechanical ventilator	hour	through study completion, an average of 1 year
Measuring of chronic health assessment II (APACHE II) scores	score	through study completion, an average of 1 year
Determination of tidal volume	mmHg	through study completion, an average of 1 year
Measuring of minute respiratory rate	counts / minute	through study completion, an average of 1 year
Determination of peak air pressure	mmHg	through study completion, an average of 1 year
Determination of mean air pressure	mmHg	through study completion, an average of 1 year
Measuring of blood lactate levels	mmol/L	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2022
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: respiratory physiotherapy
• Other Study ID Numbers: 2011-KAEK-25 2018/04-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No