Mechanical VentilationNCT06890936
Clinical Characteristics and Outcomes of Patients Requiring Mechanical Ventilation in an ICU- a Registry Based Study
An observational study of Mechanical Ventilation and Intensive Care Unit, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Intensive Care Unit
- How many people
- 1,800 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2019to 31 Dec 2024
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the ICU
Who may be able to join
- Age>18 years
- Admission to the ICU
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characteristics and Outcomes of Patients Requiring Mechanical Ventilation- a Nepalese Single Center Retrospective Study of 5 Years.
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.
Read more
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.
- Conditions
- Mechanical Ventilation, Intensive Care Unit
- Keywords
- mechanical ventilation, intensive care unit, outcomes
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 |
|---|---|---|
| MV | Patients requiring mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Mortality during ICU stay
Measured: At the end of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Nov 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,800 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bipin Karki, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890936
- Sponsor's protocol ID
- 397(6-11)E2-081/082
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of Patients Requiring Mechanical Ventilation- a Nepalese Single Center Retrospective Study of 5 Years.
- ClinicalTrials.gov ID
- NCT06890936
- Acronym / sponsor ID
- 397(6-11)E2-081/082
- Conditions
- Mechanical Ventilation, Intensive Care Unit
- Keywords
- mechanical ventilation, intensive care unit, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Mar 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MV | – | –Patients requiring mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICU
Key inclusion criteria (2 listed)
- Age>18 years
- Admission to the ICU
Key exclusion criteria (1 listed)
- None
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 mortality
Time frame: At the end of 5 years
Mortality during ICU stay
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 24 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 Mechanical Ventilation and Intensive Care Unit, 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 2 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 24 Mar 2025. 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 mortality (time frame: At the end of 5 years). 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 24 Mar 2025.