Clinical trial NCT03800849: Mechanical Ventilation Practices in Uganda's Intensive Care Units
Official title: Mechanical Ventilation Practices and 28-day Patient Mortality in Uganda's Intensive Care Units: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanically Ventilated Patients
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated Adult patients in four selected ICUs during the study period who meet the inclusion criteria.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 28 day ICU mortality of mechanically ventilated patients
timeFrame: 7 months
Secondary outcomes:
measure: Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions
timeFrame: 7 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago hospital
Study officials:
affiliation: Makerere University, Kampala
name: Irene Kyamummi, MBChB
role: PRINCIPAL_INVESTIGATOR
References: