Mechanical Ventilation Practices in Uganda's Intensive Ca... | NCT03800849

Studies
Mechanical Ventilation Practices in Uganda's Intensive Care Units

NCT03800849

Sponsor

Makerere University

Status

Unknown status

Last Update Posted

Jan 11, 2019Actual

Enrollment

214Estimated

Phase

Not provided

Conditions

Mechanically Ventilated Patients

Interventions

Not provided

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2018Actual

Primary Completion Date

Mar 14, 2019Estimated

Completion Date

Apr 30, 2019Estimated

First Submitted Date

Sep 11, 2018

First Submission Date that Met QC Criteria

Jan 10, 2019

First Posted Date

Jan 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2019

Last Update Posted Date

Jan 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

214Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Irene Kyamummi, MBChB	Contact	701 833 144	256	ikyamummi@yahoo.com

Overall Officials

Name	Affiliation	Role
Irene Kyamummi, MBChB	Makerere University, Kampala	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mulago hospital	Recruiting	Kampala		256	Uganda