NCT05303831

Brief Summary

The global mortality rate of patients on MV is very high which is varied with the income level of the country, duration of a mechanical ventilator, the pattern of disease, ICU staff profile, availability of medical supplies. All Studies conducted so far in Sub-Saharan Africa including Ethiopia among ICU patients primarily focused on the pattern of admission, the incidence of mortality, and its determinants. However, the body of evidence on the pattern of disease, the incidence of MV, and determinants of mortality among patients on MV is still uncertain and a topic of debate nationally as well as locally. Therefore, A multicenter prospective cohort study is planned to be carried out in Southern Ethiopia Teaching and referral hospital ICUs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

March 21, 2022

Last Update Submit

December 5, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of mortality

    The incidence of mortality of patients in the ICU who are on Mechanical ventilator during 28-days follow up

    28-days

  • time to death

    The time with which patients die during follow up

    28-days

Secondary Outcomes (3)

  • time to wean from the MV

    28-days

  • time to develop adverse events

    28-days

  • Incidence of prolonged ventilation

    28-days

Interventions

patients on a mechanical ventilators in ICU will be followed for 28-days for clinical outcomes

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Adult patients who are on Mechanical ventilator in Dilla University referral hospital, Wolaita Sodo University Hospital, and Hawassa University specialized Hospital ICUs during the study period

You may not qualify if:

  • Patients admitted to ICU on re-admission and patients with no attendants will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilla University

Addis Ababa, 914, Ethiopia

Location

Related Publications (1)

  • Abate SM, Basu B, Jemal B, Ahmed S, Mantefardo B, Taye T. Pattern of disease and determinants of mortality among ICU patients on mechanical ventilator in Sub-Saharan Africa: a multilevel analysis. Crit Care. 2023 Jan 24;27(1):37. doi: 10.1186/s13054-023-04316-w.

MeSH Terms

Interventions

Ventilators, Mechanical

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, thematic research leader

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

April 4, 2022

Primary Completion

August 29, 2022

Study Completion

September 20, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations