Admission Time and Outcomes of Patients Admitted to Inten... | NCT06162481

Studies
Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital

NCT06162481

Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Status

Completed

Last Update Posted

Dec 8, 2023Actual

Enrollment

3,242Actual

Phase

Not provided

Conditions

FOCUS of Study: Time of Admission to ICU and Outcome

Interventions

Not provided

Countries

Nepal

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2023Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Aug 31, 2023Actual

First Submitted Date

Nov 22, 2023

First Submission Date that Met QC Criteria

Nov 30, 2023

First Posted Date

Dec 8, 2023Actual

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

Nov 30, 2023

Last Update Posted Date

Dec 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ashmita Paudel, Principal Investigator, Tribhuvan University Teaching Hospital, Institute Of Medicine.Principal Investigator

Lead Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

An intensive care unit (ICU) is a specialized unit within the hospital where patients who need immediate medical attention are admitted both during office hours and off hours.1 Literatures report reduced working efficiency because of long working hours, unavailability of 24/7 intensivist staffing and the absence of the same level of hospital services like laboratory investigations during off hours affecting outcome of the patients. 2-6 High intensity staffing model and shorter workhours can improve the outcome.7 However, these are not always feasible in ICUs of low and middle income countries like Nepal. Any variations in outcome depending upon time of ICU admission may impact the workforce planning, medical insurance, and healthcare policy.

The aim of this study was to compare the outcomes of patients admitted to the ICU during office hours and off hours in terms of ICU mortality, duration of mechanical ventilation and length of stay.

Detailed Description

Not provided

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

3,242Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICU length of stay		Each patient will be followed till death or discharge alive from ICU whichever occurs earlier
days of mechanical ventilation		Each patient will be followed till death or liberation from Mechanical ventilation whichever occurs earlier
In ICU mortality		each patient will be followed till death or discharge from ICU whichever is earlier

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- age >= 16 years

Exclusion Criteria:

Patient who were discharged on request, left against medical advice, had withdrawal of active life support

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients admitted to ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tribhuvan University Teaching Hospital		Kathmandu	Bagmati		Nepal

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
Admitted during office hours
Admitted off hours