Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients

Completed

• Conditions: Clinical Outcomes

• Registration Number: NCT05303831
• Lead Sponsor: Dilla University

Brief Summary

The global mortality rate of patients on MV is very high which is varied with the income level of the country, duration of a mechanical ventilator, the pattern of disease, ICU staff profile, availability of medical supplies. All Studies conducted so far in Sub-Saharan Africa including Ethiopia among ICU patients primarily focused on the pattern of admission, the incidence of mortality, and its determinants. However, the body of evidence on the pattern of disease, the incidence of MV, and determinants of mortality among patients on MV is still uncertain and a topic of debate nationally as well as locally.

Therefore, A multicenter prospective cohort study is planned to be carried out in Southern Ethiopia Teaching and referral hospital ICUs.

Detailed Description

Introduction: The global mortality rate of patients on MV is very high which is varied with the income level of the country, duration of a mechanical ventilator, the pattern of disease, ICU staff profile, availability of medical supplies. All Studies conducted so far in Sub-Saharan Africa including Ethiopia among ICU patients primarily focused on the pattern of admission, the incidence of mortality, and its determinants. However, the body of evidence on the pattern of disease, the incidence of MV, and determinants of mortality among patients on MV is still uncertain and a topic of debate nationally as well as locally.

Objective: The general objective of the study is to investigate the pattern of disease and determinants of mortality among ICU patients on Mechanical ventilators in Southern Ethiopia from April 2021 to September 2022.

Methods: After obtaining Ethical clearance from Research Ethics Committee (IRB), a multi-center cohort study will be conducted in three teaching and referral hospitals in Southern Ethiopia; namely, Hawassa university referral hospital (HURH), Dilla University referral hospital (DURH), and Wolaita Sodo referral hospital (WURH) from March 2021, to September 2022. Four Hundred Forty-four consecutive Adult patients who will be on a mechanical ventilator in ICU fulfilling the inclusion criteria and will be followed for 28-days to assess the pattern of disease, survival status and determinants of mortality will be included. Data will be entered into Statistical Package for Social Sciences version 22 for analysis. Descriptive statistics will be run to see the overall distribution of the study subjects concerning the variables under study. Chi-square test and odds ratio will be used to determine the association between hypothesized independent and dependent variables. Multivariate analysis will be conducted to control possible confounders and identify independent predictors of length of ICU stay and 28- days mortality. Survival analysis and Cox regression will be done to estimate the probability of dying within 28 days and time to wean from a mechanical ventilator.

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Study Start: 2022-04-04
• Primary Completion: 2022-08-29
• Study Completion: 2022-09-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

All Adult patients greater than 12 years old and who are on Mechanical ventilators in DURH, Wolaita Sodo University Hospital, and Hawassa University specialized hospital ICUs and staying in ICU for more than 24hrs of Admission

Exclusion Criteria

• Patients admitted to ICU on re-admission and patients with no attendants will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of mortality	28-days	The incidence of mortality of patients in the ICU who are on Mechanical ventilator during 28-days follow up
time to death	28-days	The time with which patients die during follow up

Secondary Outcome Measures

Name	Time	Method
time to wean from the MV	28-days	This refers to the time when patients weaned from the MV
Incidence of prolonged ventilation	28-days	This study intends to investigate how many of patients are on mechanical ventilator for prolonged period during follow up as per the criteria of prolonged MV
time to develop adverse events	28-days	The time with which patients develop complications during follow up such as cardiac arrest, ventilator associated Pneumonia etc.

Trial Locations

Locations (1)

Dilla University; 🇪🇹 Addis Ababa, Ethiopia