Dyspnea During Mechanical VentilationNCT07205952
Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients
An observational study of Dyspnea During Mechanical Ventilation, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.
Trial summary
The investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyspnea During Mechanical Ventilation
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 22 Nov 2024to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults of either sex with respiratory failure of any cause on invasive mechanical ventilation.
Who may be able to join
- Adults of either sex (≥18 years)
- Endotracheally intubated in the past 24 hours.
- Expected to require ≥24 hours of mechanical ventilation.
Who cannot join
- Continuous neuromuscular blockade.
- Ventilated on Airway Pressure Release Ventilation mode.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de la Universidad de Buenos Aires
Buenos Aires, Buenos Aires
Celica Irrazabal, MD, 54 9 11 4969 8043, clirrazabal@gmail.com
Carlos G Sosa, MD, sosac29l@gmail.com
About this study
The investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause.
Read the detailed description
Inclusion criteria:
- Adults of either sex (≥18 years)
- Non-c0mmunicative, endotracheally intubated in the past 24 hours.
- Expected to require ≥24 hours of mechanical ventilation.
Exclusion criteria:
- Continuous neuromuscular blockade.
- Ventilated on Airway Pressure Release Ventilation mode.
Ventilator measured airway pressure and flow signals will be streamed at 31.25 Hz into 131.1-s time windows (epochs) for up to 5 days. A recursive algorithm will compute individual breath's inspiratory effort (Pmus) and calculate the inspiratory effort time-pressure product (PmusPTP cmH₂O·s·min-¹).
Trained staff will assess the Mechanical Ventilation-Respiratory Distress Observation Scale (MV-RDOS), an intermittent and subjective assessment of dyspnea, at least twice daily. These will be time-matched to the airway signal epochs to determine their degree of correlation by Pearsons R2.
Using receiver operating characteristic (ROC) area under the curve (AUC) analysis, the investigators will determine a dyspnea threshold for PmusPTP equivalent to the dyspnea cut-off for MV-RDOS > 2.6, and report sensitivity/specificity.
To address possible label misclassification, the investigators will train six supervised classifiers on concordant data pairs and apply a unanimity ensemble to label discordant pairs as "dyspneic", not dyspneic" and undetermined". Ensemble determined labels conflicting with those classified by MV-RDOS will be excluded from a secondary analysis.
Primary outcome will be Pearson's R2 (PmusPTP vs MV-RDOS). Secondary outcome will be 28-day ventilator-free days.
- Conditions
- Dyspnea During Mechanical Ventilation
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 |
|---|---|---|
| Adults on invasive mechanical ventilation | Adults of either gender on invasive mechanical ventilation within the preceding 24 hours; and an anticipated need for continued ventilation for ≥24 additional hours. Exclusion criteria are continuous neuromuscular blockade at the time of screening and ventilation using airway pressure release ventilation (APRV). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score.
The degree of correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score will be determined with Pearson's coefficient of determination (R2).
Measured: One year
Secondary outcomes (1)
Ventilator free days.
The number of days from the last day of invasive mechanical ventilation to day 28.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start22 Nov 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dyspnea During Mechanical VentilationStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas José de San Martín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celica Irrazabal, Hospital de Clinicas José de San Martín
- Investigators
- Guillermo Gutierrez, Principal investigator, The George Washington University School of Medicine and Health SciencesCelica Irrazabal, MD, Principal investigator, Hospital de Clínicas José de San Martín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205952
- Sponsor's protocol ID
- 1337-25
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Excel workbook containing deidentified enrollment information including demographics, mode of ventilation, adverse events during monitoring and outcomes. Also provided will be individual MV-RDOS measurements with time and day after enrollment. 2. Excel workbook containing paired MV-RDOS measurements and calculated PmusPTP. 3. Results of machine learning models application to study data. 4. Program used to develop the machine learning models.
Publications
Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
PubMed 22336677Gutierrez G. A non-invasive method to monitor respiratory muscle effort during mechanical ventilation. J Clin Monit Comput. 2024 Oct;38(5):1125-1134. doi: 10.1007/s10877-024-01164-z. Epub 2024 May 11.
PubMed 38733504Gutierrez G. A novel method to calculate compliance and airway resistance in ventilated patients. Intensive Care Med Exp. 2022 Dec 30;10(1):55. doi: 10.1186/s40635-022-00483-2.
PubMed 36581716Decavele M, Rozenberg E, Nierat MC, Mayaux J, Morawiec E, Morelot-Panzini C, Similowski T, Demoule A, Dres M. Respiratory distress observation scales to predict weaning outcome. Crit Care. 2022 Jun 6;26(1):162. doi: 10.1186/s13054-022-04028-7.
PubMed 35668459Demoule A, Decavele M, Antonelli M, Camporota L, Abroug F, Adler D, Azoulay E, Basoglu M, Campbell M, Grasselli G, Herridge M, Johnson MJ, Naccache L, Navalesi P, Pelosi P, Schwartzstein R, Williams C, Windisch W, Heunks L, Similowski T. Dyspnoea in acutely ill mechanically ventilated adult patients: an ERS/ESICM statement. Eur Respir J. 2024 Feb 22;63(2):2300347. doi: 10.1183/13993003.00347-2023. Print 2024 Feb.
PubMed 38387998
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07205952
- Acronym / sponsor ID
- 1337-25
- Conditions
- Dyspnea During Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas José de San MartínUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Oct 2025 (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 investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause.
Detailed description
Inclusion criteria:
- Adults of either sex (≥18 years)
- Non-c0mmunicative, endotracheally intubated in the past 24 hours.
- Expected to require ≥24 hours of mechanical ventilation.
Exclusion criteria:
- Continuous neuromuscular blockade.
- Ventilated on Airway Pressure Release Ventilation mode.
Ventilator measured airway pressure and flow signals will be streamed at 31.25 Hz into 131.1-s time windows (epochs) for up to 5 days. A recursive algorithm will compute individual breath's inspiratory effort (Pmus) and calculate the inspiratory effort time-pressure product (PmusPTP cmH₂O·s·min-¹).
Trained staff will assess the Mechanical Ventilation-Respiratory Distress Observation Scale (MV-RDOS), an intermittent and subjective assessment of dyspnea, at least twice daily. These will be time-matched to the airway signal epochs to determine their degree of correlation by Pearsons R2.
Using receiver operating characteristic (ROC) area under the curve (AUC) analysis, the investigators will determine a dyspnea threshold for PmusPTP equivalent to the dyspnea cut-off for MV-RDOS > 2.6, and report sensitivity/specificity.
To address possible label misclassification, the investigators will train six supervised classifiers on concordant data pairs and apply a unanimity ensemble to label discordant pairs as "dyspneic", not dyspneic" and undetermined". Ensemble determined labels conflicting with those classified by MV-RDOS will be excluded from a secondary analysis.
Primary outcome will be Pearson's R2 (PmusPTP vs MV-RDOS). Secondary outcome will be 28-day ventilator-free days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults on invasive mechanical ventilation | – | –Adults of either gender on invasive mechanical ventilation within the preceding 24 hours; and an anticipated need for continued ventilation for ≥24 additional hours. Exclusion criteria are continuous neuromuscular blockade at the time of screening and ventilation using airway pressure release ventilation (APRV). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults of either sex with respiratory failure of any cause on invasive mechanical ventilation.
Key inclusion criteria (3 listed)
- Adults of either sex (≥18 years)
- Endotracheally intubated in the past 24 hours.
- Expected to require ≥24 hours of mechanical ventilation.
Key exclusion criteria (2 listed)
- Continuous neuromuscular blockade.
- Ventilated on Airway Pressure Release Ventilation mode.
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
Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score.
Time frame: One year
The degree of correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score will be determined with Pearson's coefficient of determination (R2).
1 secondary outcome
Ventilator free days.
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 22336677Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
- Background: PubMed 38733504Gutierrez G. A non-invasive method to monitor respiratory muscle effort during mechanical ventilation. J Clin Monit Comput. 2024 Oct;38(5):1125-1134. doi: 10.1007/s10877-024-01164-z. Epub 2024 May 11.
- Background: PubMed 36581716Gutierrez G. A novel method to calculate compliance and airway resistance in ventilated patients. Intensive Care Med Exp. 2022 Dec 30;10(1):55. doi: 10.1186/s40635-022-00483-2.
- Background: PubMed 35668459Decavele M, Rozenberg E, Nierat MC, Mayaux J, Morawiec E, Morelot-Panzini C, Similowski T, Demoule A, Dres M. Respiratory distress observation scales to predict weaning outcome. Crit Care. 2022 Jun 6;26(1):162. doi: 10.1186/s13054-022-04028-7.
- Background: PubMed 38387998Demoule A, Decavele M, Antonelli M, Camporota L, Abroug F, Adler D, Azoulay E, Basoglu M, Campbell M, Grasselli G, Herridge M, Johnson MJ, Naccache L, Navalesi P, Pelosi P, Schwartzstein R, Williams C, Windisch W, Heunks L, Similowski T. Dyspnoea in acutely ill mechanically ventilated adult patients: an ERS/ESICM statement. Eur Respir J. 2024 Feb 22;63(2):2300347. doi: 10.1183/13993003.00347-2023. Print 2024 Feb.
- Individual participant dataSharing planned: Yes. 1. Excel workbook containing deidentified enrollment information including demographics, mode of ventilation, adverse events during monitoring and outcomes. Also provided will be individual MV-RDOS measurements with time and day after enrollment. 2. Excel workbook containing paired MV-RDOS measurements and calculated PmusPTP. 3. Results of machine learning models application to study data. 4. Program used to develop the machine learning models.
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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.
Guillermo Gutierrez principal investigator
The George Washington University School of Medicine and Health Sciences
Celica Irrazabal, MD principal investigator
Hospital de Clínicas José de San Martín
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 Dyspnea During Mechanical Ventilation, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 Argentina. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Gutierrez, MD, PhD (17035595843, gutier@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score. (time frame: One year). 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 NCT07205952, which also lists 5 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 3 Oct 2025.