NCT03800849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

January 11, 2019

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

September 11, 2018

Last Update Submit

January 10, 2019

Conditions

Mechanically Ventilated Patients

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions

    7 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago hospital

Kampala, 256, Uganda

RECRUITING

Study Officials

  • Irene Kyamummi, MBChB

    Makerere University, Kampala

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Kyamummi, MBChB

CONTACT

701 833 144ikyamummi@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

January 11, 2019

Study Start

August 14, 2018

Primary Completion

March 14, 2019

Study Completion

April 30, 2019

Last Updated

January 11, 2019

Record last verified: 2018-09

Locations

UG(1)