跳至主要内容
临床试验/NCT05303831
NCT05303831已完成不适用

Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients on Mechanical Ventilator in Southern Ethiopia: A Multi-center Prospective Cohort Study

Dilla University1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
630
试验地点
1
主要终点
Incidence of mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Incidence of mortality

时间窗: 28-days

The incidence of mortality of patients in the ICU who are on Mechanical ventilator during 28-days follow up

time to death

时间窗: 28-days

The time with which patients die during follow up

次要结局

  • time to wean from the MV(28-days)
  • Incidence of prolonged ventilation(28-days)
  • time to develop adverse events(28-days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Semagn Mekonnen

Assistant professor, thematic research leader

Dilla University

研究点 (1)

Loading locations...

相似试验