- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03800849
Mechanical Ventilation Practices in Uganda's Intensive Care Units
Mechanical Ventilation Practices and 28-day Patient Mortality in Uganda's Intensive Care Units: A Prospective Cohort Study
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Irene Kyamummi, MBChB
- Phone Number: 256 701 833 144
- Email: ikyamummi@yahoo.com
Study Locations
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Kampala, Uganda, 256
- Recruiting
- Mulago Hospital
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Contact:
- Ponsiano Ocama, PHD
- Phone Number: 256 0772421190
- Email: ponsiano.ocama@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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
Sponsor
Investigators
- Principal Investigator: Irene Kyamummi, MBChB, Makerere University, Kampala
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
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