Diaphragm UltrasonographyNCT06706830
The Role of Lung and Diaphragm Ultrasonography in Predicting Clinical Progression in Hypoxemic Respiratory Failure
An observational study of Diaphragm Ultrasonography and Lung Ultrasound, run by Simge Evren at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate whether the risk of intubation in patients with hypoxemic respiratory failure who were monitored in the intensive care unit and received non-invasive mechanical ventilation and high-flow nasal oxygen treatment could be predicted using lung and diaphragm ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Ultrasonography, Lung Ultrasound, Hypoxemic Respiratory Failure
- How many people
- 91 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 23 Aug 2024
- Phase
- Observational
- 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
Study population: Hypoxemic patients in intensive care unit
Who may be able to join
- -PaO2 <60 mmHg detected in arterial blood gas samples at the time of admission to the intensive care unit
Who cannot join
- Under the age of 18
- History of lung and diaphragm surgery
- Congenital, acquired or traumatic diaphragmatic hernia
- Diaphragm paralysis
- Hemodynamic instability requiring vasoactive drug support
- Do not agree to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Prof. Dr. Cemil Tascıoglu City Hospital
Istanbul, Şişli, 34384
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Istanbul, Şişli, 34384
About this study
Official title: The Role of Lung and Diaphragm Ultrasonography in Predicting Clinical Progression in Patients Receiving High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation Support for Hypoxemic Respiratory Failure
The goal of this observational study is to evaluate whether the risk of intubation in patients with hypoxemic respiratory failure who were monitored in the intensive care unit and received non-invasive mechanical ventilation and high-flow nasal oxygen treatment could be predicted using lung and diaphragm ultrasound.
The main question it aims to answer is:
Can lung and diaphragm ultrasound predict the risk of intubation in patients with hypoxemic respiratory failure?
Read the detailed description
Between January 1, 2024, and May 1, 2024, the diaphragm thickness fraction, excursion, LUS score, ROX index, and the LUSS/ROX index ratio were evaluated using lung and diaphragm ultrasound in 91 patients admitted to the intensive care unit with a diagnosis of hypoxemic respiratory failure. These evaluations were performed at the 6th, 12th, 24th, and 48th hours of their ICU stay, and during intubation if the decision for intubation was made
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxemic | Patients whose partial oxygen levels are low |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung and diaphragm ultrasound evaluation for risk of intubation
Lung and diaphragm ultrasound can predict risk of intubation
Measured: 48 hours
Secondary outcomes (2)
ROX index evaluation for risk of intubation
The Respiratory Rate-Oxygenation Index can predict the risk of intubation Higher score means lower risk
Measured: 48 hours
LUSS/ROX index ratio evaluation for risk of intubation
LUSS/ROX index ratio can predict the risk of intubation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm UltrasonographyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simge Evren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simge Evren, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Namigar Turgut, Study director, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706830
- Sponsor's protocol ID
- 291
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lung and Diaphragm Ultrasonography in Predicting Clinical Progression in Patients Receiving High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation Support for Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06706830
- Acronym / sponsor ID
- 291
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Simge EvrenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 27 Nov 2024 (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.
The goal of this observational study is to evaluate whether the risk of intubation in patients with hypoxemic respiratory failure who were monitored in the intensive care unit and received non-invasive mechanical ventilation and high-flow nasal oxygen treatment could be predicted using lung and diaphragm ultrasound.
The main question it aims to answer is:
Can lung and diaphragm ultrasound predict the risk of intubation in patients with hypoxemic respiratory failure?
Detailed description
Between January 1, 2024, and May 1, 2024, the diaphragm thickness fraction, excursion, LUS score, ROX index, and the LUSS/ROX index ratio were evaluated using lung and diaphragm ultrasound in 91 patients admitted to the intensive care unit with a diagnosis of hypoxemic respiratory failure. These evaluations were performed at the 6th, 12th, 24th, and 48th hours of their ICU stay, and during intubation if the decision for intubation was made
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoxemic | – | –Patients whose partial oxygen levels are low |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypoxemic patients in intensive care unit
Key inclusion criteria (1 listed)
- -PaO2 <60 mmHg detected in arterial blood gas samples at the time of admission to the intensive care unit
Key exclusion criteria (6 listed)
- Under the age of 18
- History of lung and diaphragm surgery
- Congenital, acquired or traumatic diaphragmatic hernia
- Diaphragm paralysis
- Hemodynamic instability requiring vasoactive drug support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung and diaphragm ultrasound evaluation for risk of intubation
Time frame: 48 hours
Lung and diaphragm ultrasound can predict risk of intubation
2 secondary outcomes
ROX index evaluation for risk of intubation
Time frame: 48 hours
LUSS/ROX index ratio evaluation for risk of intubation
Time frame: 48 hours
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 27 Nov 2024.
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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.
Namigar Turgut study director
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Ultrasonography and Lung Ultrasound, run by Simge Evren at 2 sites 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 6 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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Lung and diaphragm ultrasound evaluation for risk of intubation (time frame: 48 hours). 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 27 Nov 2024.