Respiratory FailureNCT05869045
POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction
An observational study of Respiratory Failure and Diaphragm Disease, run by Azienda Ospedaliero-Universitaria di Modena.
Trial summary
This study aims to evaluate the use of POCUS to assess diaphragmatic function and its association with clinical outcomes in patients with respiratory failure who are admitted to the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Diaphragm Disease
- What is being tested?
- Diaphragm shortening fraction measurement by point-of-care ultrasound.
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 May 2024
- How long will I take part?
- 30 Days
- 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: Adult patients (≥18 years old) with respiratory failure who are admitted to the emergency department
Who may be able to join
- Respiratory failure defined as one or more of the following: respiratory rate >24 breaths/min, oxygen saturation <90% on room air, PaO2/FiO2 ratio <300 mmHg, or need for supplemental oxygen
- Ability to provide informed consent or availability of a legal representative
Who cannot join
- Pregnancy
- History of thoracic surgery or trauma
- Known neuromuscular disease affecting the diaphragm
- Contraindications for POCUS examination such as chest wall deformity, subcutaneous emphysema, or skin infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Point-of-care Ultrasound (POCUS) on the Prognosis of Respiratory Failure in Patients Presenting to the Emergency Department Based on Diaphragmatic Dysfunction
This study aims to evaluate the use of POCUS to assess diaphragmatic function and its association with clinical outcomes in patients with respiratory failure who are admitted to the emergency department.
Read the detailed description
Respiratory failure is a common condition that requires prompt diagnosis and treatment in the emergency department. Diaphragmatic dysfunction (DD) is a potential contributor to respiratory failure, but it is often underdiagnosed and undertreated. Point-of-care ultrasound (POCUS) is a non-invasive and feasible tool that can measure diaphragmatic function using parameters such as diaphragm excursion and diaphragm shortening fraction (DSF). However, the prognostic value of POCUS for DD in patients with respiratory failure is unclear.
This study is a prospective observational cohort study that will enroll consecutive patients with respiratory failure who are admitted to the emergency department of a tertiary hospital. All patients will undergo POCUS examination of the diaphragm within 6 hours of admission by trained emergency physicians. The primary outcome will be the composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission. The secondary outcomes will include length of hospital stay, intensive care unit admission, and ventilator-free days. The association between POCUS parameters of diaphragmatic function and clinical outcomes will be analyzed using multivariate logistic regression and Cox proportional hazards models.
- Conditions
- Respiratory Failure, Diaphragm Disease
- Being tested
- Diaphragm shortening fraction measurement by point-of-care ultrasound.
- Keywords
- Point of care ultrasound, Diaphragm Disease
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm shortening fraction measurement by point-of-care ultrasound.Other
A noninvasive and feasible method to assess diaphragmatic function and predict the prognosis of patients with respiratory failure presenting to the emergency department. The method consists of measuring the diaphragmatic thickness at the end of inspiration and expiration using a linear probe placed in the subcostal region and calculating the percentage of change using the formula: diaphragmatic thickness at the end of inspiration - diaphragmatic thickness at the end of expiration/diaphragmatic thickness at the end of expiration×100. A value lower than 10% indicates diaphragmatic dysfunction and a higher risk of adverse outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Diaphragmatic dysfunction (DD) | Patients with diaphragmatic dysfunction measured by point-of-care ultrasound using the diaphragm shortening fraction (DSF) method, which resulted in values lower than 10%. DSF is calculated by the formula: diaphragmatic thickness at the end of inspiration - diaphragmatic thickness at the end of expiration/diaphragmatic thickness at the end of expiration×100 Receives: Other: Diaphragm shortening fraction measurement by point-of-care ultrasound. | |
| Patients without Diaphragmatic dysfunction (DD) | Patients without diaphragmatic dysfunction measured by point-of-care ultrasound using the DSF method, which resulted in values higher than 10%. Receives: Other: Diaphragm shortening fraction measurement by point-of-care ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission
Measured: Patients will be followed up for a maximum of 1 months from admission to the emergency department, until discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 432 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmine Cristiano Di Gioia, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869045
- Sponsor's protocol ID
- DSF
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Point-of-care Ultrasound (POCUS) on the Prognosis of Respiratory Failure in Patients Presenting to the Emergency Department Based on Diaphragmatic Dysfunction
- ClinicalTrials.gov ID
- NCT05869045
- Acronym / sponsor ID
- DSF
- Conditions
- Respiratory Failure, Diaphragm Disease
- Keywords
- Point of care ultrasound, Diaphragm Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 22 May 2023 (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 aims to evaluate the use of POCUS to assess diaphragmatic function and its association with clinical outcomes in patients with respiratory failure who are admitted to the emergency department.
Detailed description
Respiratory failure is a common condition that requires prompt diagnosis and treatment in the emergency department. Diaphragmatic dysfunction (DD) is a potential contributor to respiratory failure, but it is often underdiagnosed and undertreated. Point-of-care ultrasound (POCUS) is a non-invasive and feasible tool that can measure diaphragmatic function using parameters such as diaphragm excursion and diaphragm shortening fraction (DSF). However, the prognostic value of POCUS for DD in patients with respiratory failure is unclear.
This study is a prospective observational cohort study that will enroll consecutive patients with respiratory failure who are admitted to the emergency department of a tertiary hospital. All patients will undergo POCUS examination of the diaphragm within 6 hours of admission by trained emergency physicians. The primary outcome will be the composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission. The secondary outcomes will include length of hospital stay, intensive care unit admission, and ventilator-free days. The association between POCUS parameters of diaphragmatic function and clinical outcomes will be analyzed using multivariate logistic regression and Cox proportional hazards models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Diaphragmatic dysfunction (DD) | – | Other: Diaphragm shortening fraction measurement by point-of-care ultrasound.Patients with diaphragmatic dysfunction measured by point-of-care ultrasound using the diaphragm shortening fraction (DSF) method, which resulted in values lower than 10%. DSF is calculated by the formula: diaphragmatic thickness at the end of inspiration - diaphragmatic thickness at the end of expiration/diaphragmatic thickness at the end of expiration×100 |
| Patients without Diaphragmatic dysfunction (DD) | – | Other: Diaphragm shortening fraction measurement by point-of-care ultrasound.Patients without diaphragmatic dysfunction measured by point-of-care ultrasound using the DSF method, which resulted in values higher than 10%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) with respiratory failure who are admitted to the emergency department
Key inclusion criteria (2 listed)
- Respiratory failure defined as one or more of the following: respiratory rate >24 breaths/min, oxygen saturation <90% on room air, PaO2/FiO2 ratio <300 mmHg, or need for supplemental oxygen
- Ability to provide informed consent or availability of a legal representative
Key exclusion criteria (4 listed)
- Pregnancy
- History of thoracic surgery or trauma
- Known neuromuscular disease affecting the diaphragm
- Contraindications for POCUS examination such as chest wall deformity, subcutaneous emphysema, or skin infection
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 |
|---|---|---|
| Diaphragm shortening fraction measurement by point-of-care ultrasound.A noninvasive and feasible method to assess diaphragmatic function and predict the prognosis of patients with respiratory failure presenting to the emergency department. The method consists of measuring the diaphragmatic thickness at the end of inspiration and expiration using a linear probe placed in the subcostal region and calculating the percentage of change using the formula: diaphragmatic thickness at the end of inspiration - diaphragmatic thickness at the end of expiration/diaphragmatic thickness at the end of expiration×100. A value lower than 10% indicates diaphragmatic dysfunction and a higher risk of adverse outcomes. | Other | Patients with Diaphragmatic dysfunction (DD), Patients without Diaphragmatic dysfunction (DD) |
Primary outcome
Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission
Time frame: Patients will be followed up for a maximum of 1 months from admission to the emergency department, until discharge or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Diaphragm Disease, run by Azienda Ospedaliero-Universitaria di Modena.
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 4 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Carmine Cristiano Di Gioia (+39 3493812503, cristianodigioia@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission (time frame: Patients will be followed up for a maximum of 1 months from admission to the emergency department, until discharge or death). 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 22 May 2023.