Clinical trial NCT04731532: Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation
Official title: University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Medicine
Ventilators, Mechanical
Keywords: respiratory physiotherapy
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Duration of patient waking from the mechanical ventilator
timeFrame: through study completion, an average of 1 year
measure: Measuring of chronic health assessment II (APACHE II) scores
timeFrame: through study completion, an average of 1 year
measure: Determination of tidal volume
timeFrame: through study completion, an average of 1 year
measure: Measuring of minute respiratory rate
timeFrame: through study completion, an average of 1 year
measure: Determination of peak air pressure
timeFrame: through study completion, an average of 1 year
measure: Determination of mean air pressure
timeFrame: through study completion, an average of 1 year
measure: Measuring of blood lactate levels
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Seyhan Dülger
state: Yıldırım
Study officials:
References: