Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 7:07 AM
Study NCT ID:
NCT04731532
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation
Sponsor:
Bursa Yuksek Ihtisas Training and Research Hospital
Organization:
Study Overview
Official Title:
University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: