Clinical trial NCT05303831: Pattern of Disease and Determinants of Clinical Outcomes Among ICU Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Outcomes
Lead sponsor: Dilla University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 630
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Adult patients who are on Mechanical ventilator in Dilla University referral hospital, Wolaita Sodo University Hospital, and Hawassa University specialized Hospital ICUs during the study period

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of mortality
timeFrame: 28-days
measure: time to death
timeFrame: 28-days
Secondary outcomes:
measure: time to wean from the MV
timeFrame: 28-days
measure: time to develop adverse events
timeFrame: 28-days
measure: Incidence of prolonged ventilation
timeFrame: 28-days
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Dilla University
Study officials:
References: