Pulmonary MedicineNCT04731532
Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation
A study testing classical respiratory physiotherapy with thoracic vibration in people with Pulmonary Medicine and Ventilators, Mechanical, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Medicine, Ventilators, Mechanical
- What is being tested?
- classical respiratory physiotherapy with thoracic vibration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who accepted for Step 3 Intensive Care Unit and connected to mechanical ventilation
Who cannot join
- Patients with known chronic disease;
- Patients in intensive care for postoperative follow-up;
- Patients with mechanical ventilation due to chest or abdominal trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Seyhan Dülger
Bursa, Yıldırım, 16115
Seyhan Dülger, 05057482841, drsdulger@gmail.com
About this study
Official title: University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital
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.
Read more
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
- Being tested
- classical respiratory physiotherapy with thoracic vibration
- Keywords
- respiratory physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classical respiratory physiotherapy with thoracic vibrationProcedure or surgery
Also called classical respiratory physiotherapy
Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .
| Study group | Role | What they receive |
|---|---|---|
| Classical respiratory physiotherapy application | Active comparator | Patient positions, postural drainage application tapping and trifled Receives: 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 Receives: Procedure: classical respiratory physiotherapy with thoracic vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of patient waking from the mechanical ventilator
hour
Measured: through study completion, an average of 1 year
Measuring of chronic health assessment II (APACHE II) scores
score
Measured: through study completion, an average of 1 year
Determination of tidal volume
mmHg
Measured: through study completion, an average of 1 year
Measuring of minute respiratory rate
counts / minute
Measured: through study completion, an average of 1 year
Determination of peak air pressure
mmHg
Measured: through study completion, an average of 1 year
Determination of mean air pressure
mmHg
Measured: through study completion, an average of 1 year
Measuring of blood lactate levels
mmol/L
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start25 Jan 2022 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seyhan Dülger,MD, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731532
- Sponsor's protocol ID
- 2011-KAEK-25 2018/04-02
- Status last verified
- Jan 2021
- First submitted
- 20 Jun 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital
- ClinicalTrials.gov ID
- NCT04731532
- Acronym / sponsor ID
- 2011-KAEK-25 2018/04-02
- Conditions
- Pulmonary Medicine, Ventilators, Mechanical
- Keywords
- respiratory physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 25 Jan 2022 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Classical respiratory physiotherapy application | Active comparator | Procedure: classical respiratory physiotherapy with thoracic vibrationPatient positions, postural drainage application tapping and trifled |
| classical respiratory physiotherapy with thoracic vibration | Active comparator | Procedure: classical respiratory physiotherapy with thoracic vibrationThoracic 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who accepted for Step 3 Intensive Care Unit and connected to mechanical ventilation
Key exclusion criteria (3 listed)
- Patients with known chronic disease;
- Patients in intensive care for postoperative follow-up;
- Patients with mechanical ventilation due to chest or abdominal trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| classical respiratory physiotherapy with thoracic vibrationAlso: classical respiratory physiotherapyClassical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled . | Procedure or surgery | Classical respiratory physiotherapy application, classical respiratory physiotherapy with thoracic vibration |
Primary outcome
Duration of patient waking from the mechanical ventilator
Time frame: through study completion, an average of 1 year
hour
Measuring of chronic health assessment II (APACHE II) scores
Time frame: through study completion, an average of 1 year
score
Determination of tidal volume
Time frame: through study completion, an average of 1 year
mmHg
Measuring of minute respiratory rate
Time frame: through study completion, an average of 1 year
counts / minute
Determination of peak air pressure
Time frame: through study completion, an average of 1 year
mmHg
Determination of mean air pressure
Time frame: through study completion, an average of 1 year
mmHg
Measuring of blood lactate levels
Time frame: through study completion, an average of 1 year
mmol/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classical respiratory physiotherapy with thoracic vibration in people with Pulmonary Medicine and Ventilators, Mechanical, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of patient waking from the mechanical ventilator (time frame: through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.