Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients

NCT07205952 | Recruiting

• 1 other identifier: 1337-25
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause.

Conditions

Dyspnea During Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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).

  One year

Secondary Outcomes (1)

• Ventilator free days.

  One year

Study Arms (1)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults of either sex with respiratory failure of any cause on invasive mechanical ventilation.

You may qualify if:

• Adults of either sex (≥18 years)
• Endotracheally intubated in the past 24 hours.
• Expected to require ≥24 hours of mechanical ventilation.

You may not qualify if:

• Continuous neuromuscular blockade.
• Ventilated on Airway Pressure Release Ventilation mode.

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead

Study Sites (1)

Hospital de Clínicas de la Universidad de Buenos Aires

Buenos Aires, Buenos Aires, Argentina

RECRUITING

Related Publications (5)

• 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.

  PMID: 22336677 BACKGROUND

• Gutierrez 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.

  PMID: 38733504 BACKGROUND

• Gutierrez 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.

  PMID: 36581716 BACKGROUND

• Decavele 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.

  PMID: 35668459 BACKGROUND

• Demoule 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.

  PMID: 38387998 BACKGROUND

Study Officials

• Guillermo Gutierrez

  The George Washington University School of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

• Celica Irrazabal, MD

  Hospital de Clínicas José de San Martín

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Gutierrez, MD, PhD

CONTACT

17035595843; gutier@gwu.edu

Celica Irrazabal, MD

CONTACT

54 9 11 4969 8043; clirrazabal@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Intensive Care Unit and Co-Principal Investigator

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 3, 2025
• Study Start: November 22, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: January 1, 2026 through December 31, 2026
• Access Criteria: Data are available to qualified investigators on reasonable request by emailing the principal investigator

Locations

AR (1)