Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients

Clinical Outcomes Clinical Trial

— PDCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05303831
• Other study ID #: duirb/001/21-08
• Status: Completed
• Start date: April 4, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: December 2022
• Source: Dilla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: September 20, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Outcomes

Intervention

Other:
• Mechanical ventilator
patients on a mechanical ventilators in ICU will be followed for 28-days for clinical outcomes

Locations

Country	Name	City	State
Ethiopia	Dilla University	Addis Ababa

Sponsors (1)

Lead Sponsor	Collaborator
Dilla University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of mortality	The incidence of mortality of patients in the ICU who are on Mechanical ventilator during 28-days follow up	28-days
Primary	time to death	The time with which patients die during follow up	28-days
Secondary	time to wean from the MV	This refers to the time when patients weaned from the MV	28-days
Secondary	time to develop adverse events	The time with which patients develop complications during follow up such as cardiac arrest, ventilator associated Pneumonia etc.	28-days
Secondary	Incidence of prolonged ventilation	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	28-days