Acute Respiratory Failure (ARF)NCT07870174
Work of Breathing Predicts Noninvasive Ventilation Failure
An observational study of Acute Respiratory Failure (ARF), run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Acute respiratory failure is a condition in which the lungs cannot provide enough oxygen or remove enough carbon dioxide from the blood. Noninvasive ventilation supports breathing through a mask. However, this treatment may not provide enough support for some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure (ARF)
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2024to 30 Sep 2026
- 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: Adults aged 18 years or older presenting to the emergency department with acute respiratory failure of any etiology for which noninvasive mechanical ventilation is indicated. Patients meeting the study eligibility criteria will undergo work of breathing (WOB) assessment at NIV initiation and 2 hours after initiation and will be followed until hospital discharge or in-hospital death to determine whether endotracheal intubation becomes necessary despite NIV treatment.
Who may be able to join
- Age 18 years or older.
- Acute respiratory failure of any etiology for which noninvasive mechanical ventilation is indicated.
Who cannot join
- Age younger than 18 years.
- Glasgow Coma Scale (GCS) score below 15.
- Being under the influence of alcohol or illicit drugs at presentation.
- Confirmed or suspected pneumothorax.
- Trauma-related presentation to the emergency department.
- Pregnancy.
- Gastrointestinal bleeding.
- Need for immediate endotracheal intubation or cardiopulmonary resuscitation upon presentation to the emergency department.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Atatürk Research and training Hospital
Izmir, Karabağlar, 35150
About this study
Official title: Predictive Value of Work of Breathing for Noninvasive Ventilation Failure in Acute Respiratory Failure
Acute respiratory failure is a condition in which the lungs cannot provide enough oxygen or remove enough carbon dioxide from the blood. Noninvasive ventilation supports breathing through a mask. However, this treatment may not provide enough support for some patients.
This study aims to evaluate whether work of breathing (WOB), which describes the effort needed to breathe, can help predict noninvasive ventilation failure in patients with acute respiratory failure. WOB assessments will be compared between patients in whom noninvasive ventilation succeeds and those in whom it fails. The findings may help healthcare professionals identify patients who are less likely to benefit from this treatment and may need closer monitoring or additional breathing support.
- Conditions
- Acute Respiratory Failure (ARF)
- Keywords
- Work of Breathing, Emergency Department, Noninvasive Ventilation, Respiratory Effort
- Medical subject headings
- Emergencies
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 |
|---|---|---|
| Patients With Acute Respiratory Failure Receiving Noninvasive Ventilation | Patients with acute respiratory failure receiving noninvasive ventilation as part of routine clinical care. Work of breathing (WOB) will be assessed to evaluate its ability to predict noninvasive ventilation failure. Patients will be followed until hospital discharge or in-hospital death, whichever occurs first. WOB findings will be compared between patients with noninvasive ventilation success and those with noninvasive ventilation failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninvasive Ventilation Failure Requiring Endotracheal Intubation
Noninvasive ventilation (NIV) failure is defined as the development of a clinical need for endotracheal intubation despite NIV treatment. Work of breathing (WOB) will be assessed at NIV initiation and 2 hours after initiation. The predictive performance of WOB at each assessment time point for NIV failure will be evaluated.
Measured: From NIV initiation until hospital discharge or in-hospital death, whichever occurs first; WOB assessed at NIV initiation and 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start4 May 2024
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure (ARF)Studies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- 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
- 200 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hüseyin Acar, Izmir Katip Celebi University
- Investigators
- Hüseyin ACAR, Assoc. Prof, MD, Principal investigator, İzmir Katip Çelebi University, Faculty of Medicine, Emergency Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870174
- Sponsor's protocol ID
- IKC-WOB-588
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data with other researchers. Study findings will be disseminated through scientific publications and presentations using aggregate data.
Publications
Fazio SA, Lin G, Cortes-Puch I, Stocking JC, Tokeshi B, Kuhn BT, Adams JY, Harper R. Work of Breathing During Proportional Assist Ventilation as a Predictor of Extubation Failure. Respir Care. 2023 Aug;68(8):1049-1057. doi: 10.4187/respcare.10225. Epub 2023 May 9.
PubMed 37160340Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.
PubMed 32325004Duan J, Han X, Bai L, Zhou L, Huang S. Assessment of heart rate, acidosis, consciousness, oxygenation, and respiratory rate to predict noninvasive ventilation failure in hypoxemic patients. Intensive Care Med. 2017 Feb;43(2):192-199. doi: 10.1007/s00134-016-4601-3. Epub 2016 Nov 3.
PubMed 27812731Apigo M, Schechtman J, Dhliwayo N, Al Tameemi M, Gazmuri RJ. Development of a work of breathing scale and monitoring need of intubation in COVID-19 pneumonia. Crit Care. 2020 Jul 31;24(1):477. doi: 10.1186/s13054-020-03176-y. No abstract available.
PubMed 32736637
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Work of Breathing for Noninvasive Ventilation Failure in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT07870174
- Acronym / sponsor ID
- IKC-WOB-588
- Conditions
- Acute Respiratory Failure (ARF)
- Keywords
- Work of Breathing, Emergency Department, Noninvasive Ventilation, Respiratory Effort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 4 May 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 13 Oct 2026 (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.
Acute respiratory failure is a condition in which the lungs cannot provide enough oxygen or remove enough carbon dioxide from the blood. Noninvasive ventilation supports breathing through a mask. However, this treatment may not provide enough support for some patients.
This study aims to evaluate whether work of breathing (WOB), which describes the effort needed to breathe, can help predict noninvasive ventilation failure in patients with acute respiratory failure. WOB assessments will be compared between patients in whom noninvasive ventilation succeeds and those in whom it fails. The findings may help healthcare professionals identify patients who are less likely to benefit from this treatment and may need closer monitoring or additional breathing support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Acute Respiratory Failure Receiving Noninvasive Ventilation | – | –Patients with acute respiratory failure receiving noninvasive ventilation as part of routine clinical care. Work of breathing (WOB) will be assessed to evaluate its ability to predict noninvasive ventilation failure. Patients will be followed until hospital discharge or in-hospital death, whichever occurs first. WOB findings will be compared between patients with noninvasive ventilation success and those with noninvasive ventilation failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older presenting to the emergency department with acute respiratory failure of any etiology for which noninvasive mechanical ventilation is indicated. Patients meeting the study eligibility criteria will undergo work of breathing (WOB) assessment at NIV initiation and 2 hours after initiation and will be followed until hospital discharge or in-hospital death to determine whether endotracheal intubation becomes necessary despite NIV treatment.
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Acute respiratory failure of any etiology for which noninvasive mechanical ventilation is indicated.
Key exclusion criteria (8 listed)
- Age younger than 18 years.
- Glasgow Coma Scale (GCS) score below 15.
- Being under the influence of alcohol or illicit drugs at presentation.
- Confirmed or suspected pneumothorax.
- Trauma-related presentation to the emergency department.
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
Noninvasive Ventilation Failure Requiring Endotracheal Intubation
Time frame: From NIV initiation until hospital discharge or in-hospital death, whichever occurs first; WOB assessed at NIV initiation and 2 hours.
Noninvasive ventilation (NIV) failure is defined as the development of a clinical need for endotracheal intubation despite NIV treatment. Work of breathing (WOB) will be assessed at NIV initiation and 2 hours after initiation. The predictive performance of WOB at each assessment time point for NIV failure will be evaluated.
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 16 Oct 2026.
- Background: PubMed 37160340Fazio SA, Lin G, Cortes-Puch I, Stocking JC, Tokeshi B, Kuhn BT, Adams JY, Harper R. Work of Breathing During Proportional Assist Ventilation as a Predictor of Extubation Failure. Respir Care. 2023 Aug;68(8):1049-1057. doi: 10.4187/respcare.10225. Epub 2023 May 9.
- Background: PubMed 32325004Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC.
- Background: PubMed 27812731Duan J, Han X, Bai L, Zhou L, Huang S. Assessment of heart rate, acidosis, consciousness, oxygenation, and respiratory rate to predict noninvasive ventilation failure in hypoxemic patients. Intensive Care Med. 2017 Feb;43(2):192-199. doi: 10.1007/s00134-016-4601-3. Epub 2016 Nov 3.
- Background: PubMed 32736637Apigo M, Schechtman J, Dhliwayo N, Al Tameemi M, Gazmuri RJ. Development of a work of breathing scale and monitoring need of intubation in COVID-19 pneumonia. Crit Care. 2020 Jul 31;24(1):477. doi: 10.1186/s13054-020-03176-y. No abstract available.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data with other researchers. Study findings will be disseminated through scientific publications and presentations using aggregate data.
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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.
Hüseyin ACAR, Assoc. Prof, MD principal investigator
İzmir Katip Çelebi University, Faculty of Medicine, Emergency Medicine Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure (ARF), run by Izmir Katip Celebi 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 8 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 16 Oct 2026. 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?
Noninvasive Ventilation Failure Requiring Endotracheal Intubation (time frame: From NIV initiation until hospital discharge or in-hospital death, whichever occurs first; WOB assessed at NIV initiation and 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07870174, which also lists 4 linked publications.
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 16 Oct 2026.