Can Total Mechanical Power Be a Determinant of Weaning Failure in Chronic Obstructive Pulmonary Disease (COPD)?

A Comparison of Ventilator Parameters (TV, DP, Total Mechanical Power, etc.) Between Successfully and unsuccessfully Weaned Patients with COPD Undergoing Mechanical Ventilation Due to Respiratory Failure, and Diagnosed with Pneumonia or ARDS in the Intensive Care Unit."

Study Overview

• Status: Completed
• Conditions: Pneumonia; Weaning Failure; Mechanical Power; ARDS (Acute Respiratory Distress Syndrome); COPD (Chronic Obstructive Pulmonary Disease)

Detailed Description

The objective of this study is to investigate which mechanical ventilation parameters and clinical findings influence weaning success by comparing successful and unsuccessful weaning patient groups among patients diagnosed with COPD who were intubated and monitored for more than five days in the intensive care unit. The findings of this study may contribute to the development of future treatment protocols and criteria for evaluating the weaning process.

This study is planned to be conducted in two centers: Bakırköy Dr. Sadi Konuk Training and Research Hospital in Istanbul and Shahid Beheshti University of Medical Sciences, Masih Daneshvari Hospital in Tehran. This multicenter study aims to facilitate the comparison of data obtained under different geographical and clinical conditions, thereby enabling a broader analysis of factors influencing the weaning process across a larger patient population.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bakirkoy Dr Sadi Konuk Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Intubated patients with COPD which has been diagnosed Pneumonia or ARDS and have admission to icu and stayed for more than 5 years.

Description

Inclusion Criteria:

• Patients aged 18 years and older
• COPD-diagnosed patients who have been intubated and stayed in the ICU for more than 5 days

Exclusion Criteria:

• Patients without electronic medical records
• Patients under 18 years of age
• Patients diagnosed with pulmonary malignancy
• Patients who stayed in the ICU for less than 5 days
• Patients monitored in the ICU without intubation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Weaned; patients with successful weaning from mechanic ventilator
Non-weaned; patients who have failed to wean from ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Weaning	The primary outcome of this study will be the successful weaning from mechanical ventilation. This will be defined as the patient being successfully extubated and maintaining adequate oxygenation for more than 48 hours without requiring reintubation or mechanical ventilation support.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Ventilator Parameters	A comparison of total mechanical power between the weaned and non-weaned patient groups.	48 hours

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Collaborators: Masih Daneshvari Hospital
• Investigators: Study Chair: Zafer Cukurova, M.D, Bakırköy Dr. Sadi Konuk Training and Research Hospital; Study Director: Seyed Mohammadreza Hashemian, M.D, Masih Daneshvari Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Actual): December 23, 2024
• Study Completion (Actual): December 23, 2024

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Mechanical Power
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2024-12-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No