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CompletedNCT07870174Updated Oct 16, 2026

Work of Breathing Predicts Noninvasive Ventilation Failure

An observational study in Acute Respiratory Failure (ARF), sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Izmir Katip Celebi University · Observational

Updated Oct 15, 2026Eligibility revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Acute Respiratory Failure (ARF)

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Keywords

  • Work of Breathing
  • Emergency Department
  • Noninvasive Ventilation
  • Respiratory Effort
03

In context

Emergencies

1,721 studies on the registry are indexed under Emergencies; 335 are open to participants now.

This study's enrollment of 200 is below the median of 351 across 726 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older.
  • Acute respiratory failure of any etiology for which noninvasive mechanical ventilation is indicated.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From NIV initiation until hospital discharge or in-hospital death, whichever occurs first; WOB assessed at NIV initiation and 2 hours.

07

Study locations

1 site
  • İzmir Atatürk Research and training Hospital
    Izmir, Karabağlar 35150, Turkey (Türkiye)
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References and documents

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 37160340 ↗
  • Tonelli 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 32325004 ↗
  • Duan 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 27812731 ↗
  • Apigo 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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Sep 2026, 28 months.

Of 310 non-industry observational studies under Emergencies, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 28 months is above that.

Counting every sponsor, half of 321 studies reached it within 14 months; a quarter within 5 and three quarters within 30.

Emergencies covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartActual
May 4, 2024
Primary completionActual
Sep 30, 2026
CompletionActual
Sep 30, 2026
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
eligibility
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 15, 2026
    Eligibility Criteria revised
    + 1 other change: responsible party
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870174
Responsible party
Hüseyin Acar (Associate Professor of Emergency Medicine, Izmir Katip Celebi University) — Principal investigator
First posted
Oct 13, 2026
Start date
May 4, 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026
Last update
Oct 16, 2026

Study contacts

Hüseyin ACAR, Assoc. Prof, MD
principal investigator · İzmir Katip Çelebi University, Faculty of Medicine, Emergency Medicine Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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