NCT06890936

Brief Summary

Rationale: Patients admitted to the Intensive Care Unit (ICU) often require respiratory support in terms of mechanical ventilation (either non-invasive or invasive). Though these patients may be diverse in clinical characteristics, the need of respiratory support in itself is in many conditions a factor relating poorer outcomes. The exact association of the requirement of respiratory support in our patient population is missing in the current literature. This study will look at 5-year data of patients admitted to the ICUs of Tribhuvan University Teaching Hospital and try to characterize these patients according to their clinical profile. Further, this study will also help to generate data regarding the outcomes of such patients. Study Objective: To characterize the patients requiring respiratory support in the ICUs of TUTH and find their outcomes in terms of ICU mortality. Design: A registry based, retrospective, descriptive, cohort study. Sample size: Convenience sampling of all the patients who are admitted to the ICU. Duration: Retrospective data from the 5-year period between November 1, 2019 to December 31, 2024. Place: Intensive care units (ICUs), Tribhuvan University Teaching Hospital (TUTH). Interventions: Not applicable Expected results: The study will help determine the clinical characteristics of patients admitted to the ICUs of TUTH requiring respiratory support and their associated outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

5.2 years

First QC Date

March 16, 2025

Last Update Submit

March 20, 2025

Conditions

Keywords

mechanical ventilationintensive care unitoutcomes

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    Mortality during ICU stay

    At the end of 5 years

Study Arms (1)

MV

Patients requiring mechanical ventilation

Eligibility Criteria

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

All patients admitted to the ICU

You may qualify if:

  • Age\>18 years
  • Admission to the ICU

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University Teaching Hospital

Mahārājgañj, Bagmati, 44600, Nepal

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 16, 2025

First Posted

March 24, 2025

Study Start

November 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations