Outcome and Predictors of Mortality of Patients on Prolonged Mechanical Ventilation

April 29, 2024 updated by: Sara Timerga, Wollo University

Outcome and Predictors of Mortality of Patients on Prolonged Mechanical Ventilation in Critically Ill Patients: a Multicenter Retrospective Cohort Study

Prolonged mechanical ventilation (PMV) and weaning failure are factors associated with prolonged hospital length of stay and increased morbidity and mortality. In addition to the individual challenges that stress patients and their families, the resource-intensive care these patients receive places a significant burden on the public health system. These burdens often persist over the long term, especially in the case of weaning failure with subsequent home mechanical ventilation (HMV).

This study will provide invaluable and in-depth knowledge of major sources of admission to ICU and will clarify the cause for the outcomes seen after prolonged mechanical ventilation in ICU admission, at Dessie comprehensive Hospital, the result of our study will also serve as a source or baseline information for future valuable researches to be undergone around the subject of interest.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The number of patients requiring prolonged mechanical ventilation after acute illness is increasing. Their long-term outcome is poor and has not improved significantly over the past 20 years. The symptom burden for patients is considerable, and family members often suffer from significant physical and emotional strain. Long-term survivors report lasting physical limitations, but their emotional health is generally good. Care for many patients requiring prolonged mechanical ventilation is shifting t post-intensive care unit settings. While this trend has resulted in cost savings for hospitals and payers, it has not had a major impact on patient outcomes.

Patients requiring prolonged mechanical ventilation consume a disproportionate amount of healthcare resources and clinician time. Measurement and knowledge of their outcomes will guide efforts to improve their care.

This study will be conducted in Dessie Comprehensive Specialized Hospital from August 2023 to January 2024. A retrospective cohort study will be conducted. Data will be checked, coded, entered, and analyzed using SPSS version 22 software. Descriptive statistics will be used to summarize data, tables, and figures for display results. Bivariate and multivariate analyses will be used to see the effect of the independent variable on the outcome variable. Variables that are significant on bivariate analysis at a p-value less than 0.2 will be taken to multivariate analysis. In multivariate analysis, a p-value of less than 0.05 will be used as a cut-off point for the presence of association. The strength of the association will be measured by 95% confidence interval and odd ratio.

Study Type

Observational

Enrollment (Estimated)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All charts of critically ill patients admitted to ICU of Dessie comprehensive specialized hospital.

Description

Inclusion Criteria:

  • All charts of critically ill patients on prolonged mechanical ventilation in of Dessie Comprehensive Specialized Hospital during the study period.

Exclusion Criteria:

  • Charts with incomplete information and missing values as well as those that are not available will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcomes of critically ill patients undergoing prolonged mechanical ventilation
Time Frame: 5 months

Clinical outcome: indicated either patient survived or died at the time of discharge.

Prolonged mechanical ventilation: is defined as successful extubation after more than three spontaneous breathing trials or taking more than 14 days

5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PMV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators plan to share the individual participant data when asked.

IPD Sharing Time Frame

The data will be available with 5 month time.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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