NCT06087939

Brief Summary

Prolonged mechanical ventilation (PMV) and weaning failure are factors associated with prolonged hospital length of stay and increased morbidity and mortality. In addition to the individual challenges that stress patients and their families, the resource-intensive care these patients receive places a significant burden on the public health system. These burdens often persist over the long term, especially in the case of weaning failure with subsequent home mechanical ventilation (HMV). This study will provide invaluable and in-depth knowledge of major sources of admission to ICU and will clarify the cause for the outcomes seen after prolonged mechanical ventilation in ICU admission, at Dessie comprehensive Hospital, the result of our study will also serve as a source or baseline information for future valuable researches to be undergone around the subject of interest.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

September 29, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

September 29, 2023

Last Update Submit

April 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical outcomes of critically ill patients undergoing prolonged mechanical ventilation

    Clinical outcome: indicated either patient survived or died at the time of discharge. Prolonged mechanical ventilation: is defined as successful extubation after more than three spontaneous breathing trials or taking more than 14 days

    5 months

Interventions

Mechanical ventilation (MV) is a life support technique that is routinely used in the intensive care units (ICUs) for patients with life-threatening conditions.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All charts of critically ill patients admitted to ICU of Dessie comprehensive specialized hospital.

You may qualify if:

  • All charts of critically ill patients on prolonged mechanical ventilation in of Dessie Comprehensive Specialized Hospital during the study period.

You may not qualify if:

  • Charts with incomplete information and missing values as well as those that are not available will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 18, 2023

Study Start

July 15, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

The investigators plan to share the individual participant data when asked.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available with 5 month time.