FOCUS of Study: Time of Admission to ICU and OutcomeNCT06162481
Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital
An observational study of FOCUS of Study: Time of Admission to ICU and Outcome, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- FOCUS of Study: Time of Admission to ICU and Outcome
- How many people
- 3,242 participants
- Where
- 1 siteNepal
- Study dates
- 15 Mar 2023to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients admitted to ICU
Who may be able to join
- age >= 16 years
Who cannot join
- Patient who were discharged on request, left against medical advice, had withdrawal of active life support
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Admitted during office hours | Not described | |
| Admitted off hours | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay
Measured: Each patient will be followed till death or discharge alive from ICU whichever occurs earlier
days of mechanical ventilation
Measured: Each patient will be followed till death or liberation from Mechanical ventilation whichever occurs earlier
In ICU mortality
Measured: each patient will be followed till death or discharge from ICU whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Mar 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FOCUS of Study: Time of Admission to ICU and OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashmita Paudel, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162481
- Sponsor's protocol ID
- 4 4 2 ( 6 - 1 1 ) 6 2
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital
- ClinicalTrials.gov ID
- NCT06162481
- Acronym / sponsor ID
- 4 4 2 ( 6 - 1 1 ) 6 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,242 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Admitted during office hours | – | – |
| Admitted off hours | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to ICU
Key inclusion criteria (1 listed)
- age >= 16 years
Key exclusion criteria (1 listed)
- Patient who were discharged on request, left against medical advice, had withdrawal of active life support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU length of stay
Time frame: Each patient will be followed till death or discharge alive from ICU whichever occurs earlier
days of mechanical ventilation
Time frame: Each patient will be followed till death or liberation from Mechanical ventilation whichever occurs earlier
In ICU mortality
Time frame: each patient will be followed till death or discharge from ICU whichever is earlier
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FOCUS of Study: Time of Admission to ICU and Outcome, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU length of stay (time frame: Each patient will be followed till death or discharge alive from ICU whichever occurs earlier). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.