Mechanical Ventilation Practices in Uganda's Intensive Care Units

Mechanically Ventilated Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800849
• Other study ID #: Ventilation
• Status: Recruiting
• Start date: August 14, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2018
• Source: Makerere University
• Contact: Irene Kyamummi, MBChB
• Phone: 701 833 144
• Email: ikyamummi[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: April 30, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanically Ventilated Patients

Locations

Country	Name	City	State
Uganda	Mulago hospital	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day ICU mortality of mechanically ventilated patients	Patients will be followed up either to discharge or death in ICU to a maximum of 28 days	7 months
Secondary	Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions	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