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

NCT04731532 | Unknown

• 1 other identifier: 2011-KAEK-25 2018/04-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

respiratory physiotherapy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Classical respiratory physiotherapy application

ACTIVE COMPARATOR

Patient positions, postural drainage application tapping and trifled

Procedure: classical respiratory physiotherapy with thoracic vibration

classical respiratory physiotherapy with thoracic vibration

ACTIVE COMPARATOR

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

Interventions

classical respiratory physiotherapy with thoracic vibration PROCEDURE

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

Also known as: classical respiratory physiotherapy

Classical respiratory physiotherapy application; classical respiratory physiotherapy with thoracic vibration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Seyhan Dülger

Bursa, Yıldırım, 16115, Turkey (Türkiye)

RECRUITING

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: pulmonary department, physical therapy and rehabilitation, anesthesiology and reanimation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, controlled study

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: February 1, 2021
• Study Start: January 25, 2022
• Primary Completion: January 31, 2022
• Study Completion: January 30, 2023
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)