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Not yet recruiting NCT07109206

Cardio-circulatory and Respiratory Monitoring for Prediction of Outcome in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

— Observational COPD (Chronic Obstructive Pulmonary Disease) Cardiometry Weaning Invasive Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), Cardiometry, Weaning Invasive Mechanical Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Chronic Obstructive Pulmonary Disease (COPD) remains a leading cause of morbidity and mortality worldwide, often necessitating invasive mechanical ventilation (MV) during acute exacerbations. Weaning these patients from MV is a critical juncture in their care, as prolonged ventilation is associated with increased complications, including ventilator-associated pneumonia, diaphragmatic dysfunction, and higher healthcare costs. Traditional weaning indices, such as the Rapid Shallow Breathing Index (RSBI), Maximum Inspiratory Pressure (MIP), and the Integrative Weaning Index (IWI), New Integrative Weaning Index (NIWI) have been employed to predict weaning outcomes. However, their predictive accuracy in COPD patients is variable, often due to the heterogeneous nature of the disease and the presence of comorbidities. Recent advancements have introduced non-invasive hemodynamic monitoring tools, such as the ICON® (Electrical Cardiometry), which measures parameters like cardiac output, stroke volume, and thoracic fluid content. These parameters may offer additional insights into a patient's readiness for weaning by providing real-time data on cardiovascular and fluid status, which are crucial in the weaning process. There is a scarcity of data comparing the predictive value of ICON parameters with traditional weaning indices in COPD patients. Understanding whether ICON-derived metrics can enhance weaning predictions and lead to more individualized and effective weaning strategies, reducing the duration of MV and improving patient outcomes.

Primary outcome measures

  • Evaluate the accuracy of non-invasive hemodynamic parameters using Electric Cardiometry to predict weaning outcome in mechanically ventilated COPD patients. [Time frame: 2 Years]
Secondary outcome measures (1)
  • Evaluate respiratory indices (RSBI, IWI, MIWI) as predictors of weaning outcome in mechanically ventilated COPD patients [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • All COPD patients who are mechanically ventilated for more than 48 h due to acute exacerbation and fulfilling weaning criteria will be included in the study.

Exclusion criteria

  • Patients younger than 18 years old.
  • Patients with pneumothorax, pleural, or pericardial effusion.
  • Patients with injuries, burns, or wounds which precludes the proper application of the device electrodes.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University Medical School. — Asyut

Publications

  • Hajian-Tilaki K. Receiver Operating Characteristic (ROC) Curve Analysis for Medical Diagnostic Test Evaluation. Caspian J Intern Med. 2013 Spring;4(2):627-35. PMID 24009950
  • McHugh ML. The chi-square test of independence. Biochem Med (Zagreb). 2013;23(2):143-9. doi: 10.11613/bm.2013.018. PMID 23894860
  • Paulus WJ. H2FPEF Score: At Last, a Properly Validated Diagnostic Algorithm for Heart Failure With Preserved Ejection Fraction. Circulation. 2018 Aug 28;138(9):871-873. doi: 10.1161/CIRCULATIONAHA.118.035711. No abstract available. PMID 30354456
  • Pfeffer MA, Shah AM, Borlaug BA. Heart Failure With Preserved Ejection Fraction In Perspective. Circ Res. 2019 May 24;124(11):1598-1617. doi: 10.1161/CIRCRESAHA.119.313572. PMID 31120821
  • Papadimitriou L, Georgiopoulou VV, Kort S, Butler J, Kalogeropoulos AP. Echocardiography in Acute Heart Failure: Current Perspectives. J Card Fail. 2016 Jan;22(1):82-94. doi: 10.1016/j.cardfail.2015.08.001. Epub 2015 Aug 13. PMID 26277267
  • Fathy S, Hasanin AM, Raafat M, Mostafa MMA, Fetouh AM, Elsayed M, Badr EM, Kamal HM, Fouad AZ. Thoracic fluid content: a novel parameter for predicting failed weaning from mechanical ventilation. J Intensive Care. 2020 Mar 5;8:20. doi: 10.1186/s40560-020-00439-2. eCollection 2020. PMID 32161651
  • Vahedian-Azimi A, Gohari-Moghadam K, Rahimi-Bashar F, Samim A, Khoshfetrat M, Mohammadi SM, de Souza LC, Mahmoodpoor A. New integrated weaning indices from mechanical ventilation: A derivation-validation observational multicenter study. Front Med (Lausanne). 2022 Jul 22;9:830974. doi: 10.3389/fmed.2022.830974. eCollection 2022. PMID 35935785
  • Schmidt GA, Girard TD, Kress JP, Morris PE, Ouellette DR, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Truwit JD. Liberation From Mechanical Ventilation in Critically Ill Adults: Executive Summary of an Official American College of Chest Physicians/American Thorac PMID 27818329

Identifiers

NCT: NCT07109206 · KarimPhD1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗