Mechanical Ventilation Practices in Uganda's Intensive Care Units

January 10, 2019 updated by: Makerere University

Mechanical Ventilation Practices and 28-day Patient Mortality in Uganda's Intensive Care Units: A Prospective Cohort Study

A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Patients will then be followed up for death / discharge within 28 days in ICU.

Study Overview

Status

Unknown

Detailed Description

Background: The need for mechanical ventilation is one of the commonest indication for admission to the ICU. Despite the clear benefits of mechanical ventilation, it may be detrimental to the patient if poorly carried out. This has led to a renewed impetus in employing lung protective ventilation strategies, Ventilator Associated Events (VAE) prevention strategies, and safe and appropriate weaning methods to reduce mortality among mechanically ventilated patients. However, there is paucity of data regarding these practices in low-income settings.

Objective: To describe the mechanical ventilation practices, mortality rate and associated factors among mechanically ventilated patients in Uganda's intensive care units.

Methodology: A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Patients will then be followed up for death / discharge within 28 days in ICU.

Data analysis: The primary outcome is all-cause mortality during ICU stay. Data will be summarised into means and standard deviations, medians and interquartile ranges and presented in tables, charts, cross-tabulations and graphs. Univariate and multivariate logistic regression will be used to determine factors associated with mortality.

Utility of results: The results from this study will be disseminated to the Ministry of Health and Makerere University in order to plan, standardise and form guidelines regarding mechanical ventilation practices in ICUs in Uganda.

Study Type

Observational

Enrollment (Anticipated)

214

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

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Mechanically ventilated Adult patients in four selected ICUs during the study period who meet the inclusion criteria.

Description

Inclusion Criteria:

  • All adult patients 18 years and above, initiated on mechanical ventilation, admitted into study ICU during the study period

Exclusion Criteria:

  • Patients ventilated in another ICU for more than 24 hours and transferred to study ICUs

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 day ICU mortality of mechanically ventilated patients
Time Frame: 7 months
Patients will be followed up either to discharge or death in ICU to a maximum of 28 days
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions
Time Frame: 7 months
At discharge, death or at the end of 28 days, the duration of mechanical ventilation, ventilatory settings used and complementary interventions will be described.
7 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Irene Kyamummi, MBChB, Makerere University, Kampala

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 (Actual)

August 14, 2018

Primary Completion (Anticipated)

March 14, 2019

Study Completion (Anticipated)

April 30, 2019

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Ventilation

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.

Clinical Trials on Mechanically Ventilated Patients

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