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

Ventilators, Mechanical Clinical Trial

Official title:

University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731532
• Other study ID #: 2011-KAEK-25 2018/04-02
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: January 2021
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 30, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Medicine
• Ventilators, Mechanical

Intervention

Procedure:
• classical respiratory physiotherapy with thoracic vibration
Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .

Locations

Country	Name	City	State
Turkey	Seyhan Dülger	Bursa	Yildirim

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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

External Links

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