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

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04731532
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
12.2
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: classical respiratory physiotherapy with thoracic vibration
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, controlled studyrandomized, controlled study
Masking:
Double (Participant, Care Provider)
Masking Description:
pulmonary department, physical therapy and rehabilitation, anesthesiology and reanimation
Primary Purpose:
Treatment
Official Title:
University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital
Anticipated Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of patient waking from the mechanical ventilator [through study completion, an average of 1 year]

      hour

    2. Measuring of chronic health assessment II (APACHE II) scores [through study completion, an average of 1 year]

      score

    3. Determination of tidal volume [through study completion, an average of 1 year]

      mmHg

    4. Measuring of minute respiratory rate [through study completion, an average of 1 year]

      counts / minute

    5. Determination of peak air pressure [through study completion, an average of 1 year]

      mmHg

    6. Determination of mean air pressure [through study completion, an average of 1 year]

      mmHg

    7. Measuring of blood lactate levels [through study completion, an average of 1 year]

      mmol/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seyhan Dülger Bursa Yıldırım Turkey 16115

    Sponsors and Collaborators

    • Bursa Yüksek İhtisas Education and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Seyhan Dülger,MD, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04731532
    Other Study ID Numbers:
    • 2011-KAEK-25 2018/04-02
    First Posted:
    Feb 1, 2021
    Last Update Posted:
    Feb 1, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seyhan Dülger,MD, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
    respiratory physiotherapy

    Study Results

    No Results Posted as of Feb 1, 2021