Respiratory FailureNCT04670939
Respiratory Physiotherapy in Mechanical Ventilation
A study testing breath exercises in people with Respiratory Failure, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of respiratory physiotherapy that is breathing exercise during weaning on ventilated patients in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- breath exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2018to 1 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- weaning period of patients in invasive mechanical ventilation
- patients in stable hemodynamic parameters
Who cannot join
- under 18 years old
- pregnant
- non-cooperative
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Reasearch and Treaninig Hospital
Muğla, 48000
About this study
Official title: the Effect of Respiratory Physiotherapy to Weaning in Invasive Mechanical Ventilation
This study aimed to evaluate the effect of respiratory physiotherapy that is breathing exercise during weaning on ventilated patients in ICU.
Read the detailed description
Respiratory physiotherapy is a treatment approach to increase ventilation and function in patients with acute and chronic problems and to reduce respiratory work and dyspnea.Airway cleaning techniques, lung volume-enhancing approaches, thoracic mobilization, positioning, breathing exercises and inhalation therapy are among the strategies used.
In patients with invasive MV support, respiratory physiotherapy is the position, tracheal cleaning and inhalation therapy when necessary. But breathing exercises are not indicated in the acute phase. In the process of weaning, inspiratory muscle training and breathing exercises can be used.
- Conditions
- Respiratory Failure
- Being tested
- breath exercises
- Keywords
- respiratory physiotherapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breath exercisesProcedure or surgery
diaphragmatic breathing exercise that used during weaning is the respiratory physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| SPT | Experimental | Not described Receives: Procedure: breath exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning success
effect of respiratory physiotherapy as diaphragmatic exercise of weaning
Measured: 1-7 days
Secondary outcomes (3)
Compliance
effect of diaphragmatic exercise on compliance, diaphragmatic movement
Measured: 1-7 days
diaphragmatic movement
effect of diaphragmatic exercise on diaphragmatic movement
Measured: 1-7 days
arterial blood gas
effect of diaphragmatic exercise on diaphragmatic movement
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start20 Jul 2018
- Primary completion18 Mar 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Gursoy, Muğla Sıtkı Koçman University
- Investigators
- Canan Gürsoy, Principal investigator, Muğla Sıtkı Koçaman University, Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670939
- Sponsor's protocol ID
- SFT-CNN
- Status last verified
- Dec 2020
- First submitted
- 18 Aug 2019
- Last updated
- 17 Dec 2020
- 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Respiratory Physiotherapy to Weaning in Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04670939
- Acronym / sponsor ID
- SFT-CNN
- Conditions
- Respiratory Failure
- Keywords
- respiratory physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 17 Dec 2020 (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.
This study aimed to evaluate the effect of respiratory physiotherapy that is breathing exercise during weaning on ventilated patients in ICU.
Detailed description
Respiratory physiotherapy is a treatment approach to increase ventilation and function in patients with acute and chronic problems and to reduce respiratory work and dyspnea.Airway cleaning techniques, lung volume-enhancing approaches, thoracic mobilization, positioning, breathing exercises and inhalation therapy are among the strategies used.
In patients with invasive MV support, respiratory physiotherapy is the position, tracheal cleaning and inhalation therapy when necessary. But breathing exercises are not indicated in the acute phase. In the process of weaning, inspiratory muscle training and breathing exercises can be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPT | Experimental | Procedure: breath exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- weaning period of patients in invasive mechanical ventilation
- patients in stable hemodynamic parameters
Key exclusion criteria (3 listed)
- under 18 years old
- pregnant
- non-cooperative
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 |
|---|---|---|
| breath exercisesdiaphragmatic breathing exercise that used during weaning is the respiratory physiotherapy | Procedure or surgery | SPT |
Primary outcome
weaning success
Time frame: 1-7 days
effect of respiratory physiotherapy as diaphragmatic exercise of weaning
3 secondary outcomes
Compliance
Time frame: 1-7 days
diaphragmatic movement
Time frame: 1-7 days
arterial blood gas
Time frame: 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Respiratory Failure
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
Not yet recruitingObservational study
Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Recruiting
Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
Respiratory Insufficiency, Wounds and Injuries
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Canan Gürsoy principal investigator
Muğla Sıtkı Koçaman University, Training And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breath exercises in people with Respiratory Failure, run by Muğla Sıtkı Koçman University 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 2 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: finished, as of the sponsor's last update on 17 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning success (time frame: 1-7 days). 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 17 Dec 2020.