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

NCT ID: NCT07109206

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-30

Study Completion Date

2028-07-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 ICONĀ® (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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Success

Cases with successful weaning and extubation from mechanical ventilation

No interventions assigned to this group

Failed

Group with failed weaning trial

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

1. Patients younger than 18 years old.
2. Patients with pneumothorax, pleural, or pericardial effusion.
3. Patients with injuries, burns, or wounds which precludes the proper application of the device electrodes.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karim Osama Mohammed Sleem

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karim Sleem, Master's Degree

Role: PRINCIPAL_INVESTIGATOR

Assiut University Medical School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University Medical School.

Asyut, Egypt, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karim Osama Sleem, Masters Degree of Medicine

Role: CONTACT

+201008955986

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karim Sleem, Masters Degree

Role: primary

01008955986

References

Explore related publications, articles, or registry entries linked to this study.

Hajian-Tilaki K. Receiver Operating Characteristic (ROC) Curve Analysis for Medical Diagnostic Test Evaluation. Caspian J Intern Med. 2013 Spring;4(2):627-35.

Reference Type BACKGROUND
PMID: 24009950 (View on PubMed)

McHugh ML. The chi-square test of independence. Biochem Med (Zagreb). 2013;23(2):143-9. doi: 10.11613/bm.2013.018.

Reference Type BACKGROUND
PMID: 23894860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30354456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31120821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26277267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32161651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35935785 (View on PubMed)

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 Thoracic Society Clinical Practice Guideline. Chest. 2017 Jan;151(1):160-165. doi: 10.1016/j.chest.2016.10.037. Epub 2016 Nov 3.

Reference Type BACKGROUND
PMID: 27818329 (View on PubMed)

Sungono V, Hariyanto H, Soesilo TEB, Adisasmita AC, Syarif S, Lukito AA, Widysanto A, Puspitasari V, Tampubolon OE, Sutrisna B, Sudaryo MK. Cohort study of the APACHE II score and mortality for different types of intensive care unit patients. Postgrad Med J. 2022 Dec 1;98(1166):914-918. doi: 10.1136/postgradmedj-2021-140376.

Reference Type BACKGROUND
PMID: 37063012 (View on PubMed)

Abdelgawad TA, Ibrahim HM, Elsayed EM, Abdelhamid NS, Bawady SAH, Rezk AR. Hemodynamic monitoring during weaning from mechanical ventilation in critically ill pediatric patients: a prospective observational study. BMC Pediatr. 2024 Oct 26;24(1):681. doi: 10.1186/s12887-024-05110-5.

Reference Type BACKGROUND
PMID: 39462317 (View on PubMed)

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

Reference Type BACKGROUND
PMID: 17695343 (View on PubMed)

Zakarias D, Marics G, Kovacs K, Jermendy A, Vatai B, Schuster G, Toth-Heyn P, Szabo J A, Lodi C. [Clinical application of the electric cardiometry based non-invasive ICON(R) hemodynamic monitor]. Orv Hetil. 2018 Nov;159(44):1775-1781. doi: 10.1556/650.2018.31225. Hungarian.

Reference Type BACKGROUND
PMID: 30392409 (View on PubMed)

Greiwe G, Saad R, Hapfelmeier A, Neumann N, Tariparast P, Saugel B, Flick M. Electrical cardiometry for non-invasive cardiac output monitoring: a method comparison study in patients after coronary artery bypass graft surgery. J Clin Monit Comput. 2025 Apr;39(2):371-376. doi: 10.1007/s10877-024-01246-y. Epub 2024 Dec 11.

Reference Type BACKGROUND
PMID: 39661264 (View on PubMed)

Nemer SN, Barbas CS, Caldeira JB, Carias TC, Santos RG, Almeida LC, Azeredo LM, Noe RA, Guimaraes BS, Souza PC. A new integrative weaning index of discontinuation from mechanical ventilation. Crit Care. 2009;13(5):R152. doi: 10.1186/cc8051. Epub 2009 Sep 22.

Reference Type BACKGROUND
PMID: 19772625 (View on PubMed)

Agusti A, Vogelmeier C, Faner R. COPD 2020: changes and challenges. Am J Physiol Lung Cell Mol Physiol. 2020 Nov 1;319(5):L879-L883. doi: 10.1152/ajplung.00429.2020. Epub 2020 Sep 23. No abstract available.

Reference Type BACKGROUND
PMID: 32964724 (View on PubMed)

Huo Y, Guo S, Zhang K, Zhang T, Li B, Zhang Q, Han Y, Wang X, Hu Z. A clinical study on the ability of the integrative weaning index to predict weaning from mechanical ventilation. Ann Palliat Med. 2020 Sep;9(5):3162-3169. doi: 10.21037/apm-20-1335.

Reference Type BACKGROUND
PMID: 33065782 (View on PubMed)

Gadre SK, Duggal A, Mireles-Cabodevila E, Krishnan S, Wang XF, Zell K, Guzman J. Acute respiratory failure requiring mechanical ventilation in severe chronic obstructive pulmonary disease (COPD). Medicine (Baltimore). 2018 Apr;97(17):e0487. doi: 10.1097/MD.0000000000010487.

Reference Type BACKGROUND
PMID: 29703009 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KarimPhD1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.