Respiratory FailureICUNCT05591209
Pattern of Admission and Outcome of Patients Admitted to the Intensive Care
An observational study of Respiratory Failure and Treatment Outcome, run by Haramaya Unversity at 2 sites in Ethiopia.
Trial summary
The study was a retrospective observational cohort where patient medical record review was done and data were gathered on 419 cases. The ICU admission pattern and patient outcome were the primary outcomes presented in the manuscript. Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Respiratory Failure, Treatment Outcome
- How many people
- 419 participants
- Where
- 2 sitesEthiopia
- Study dates
- 1 Apr 2022to 30 Aug 2022
- 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 4 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: all patients admitted to ICU of HrU- HFCSH
Who may be able to join
- complete medical record
- admission to ICU
Who cannot join
- patients who were transferred or self discharged
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Pattern of Admission and Outcome of Patients Admitted to the Intensive Care Unit of a Tertiary Hospital in Low Resource Setting. A Cohort Study
The study was a retrospective observational cohort where patient medical record review was done and data were gathered on 419 cases. The ICU admission pattern and patient outcome were the primary outcomes presented in the manuscript.
Read the detailed description
The study was conducted at a teaching University hospital in a low-resource setting retrospectively on admission to ICU over the last five years. samples were selected using a simple random sampling technique to come up with the desired number.
- Conditions
- Respiratory Failure, Treatment Outcome
- Medical subject headings
- Respiratory Insufficiency
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 |
|---|---|---|
| Alive and Dead | Following ICU admission patients are followed until discharge with the outcome of alive or dead |
What is being measured
The primary outcome is the main question the study is designed to answer.
pattern of admission and outcome of patients admitted to the Intensive care Unit of a tertiary hospital in Low resource setting. A cohort study
a retrospective cohort study
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Apr 2022
- Primary completion30 Apr 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Retrospective
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haramaya Unversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Badhaasaa, Haramaya Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591209
- Sponsor's protocol ID
- IHRERC/052/2022
- Acronym
- ICU
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be exposed
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Admission and Outcome of Patients Admitted to the Intensive Care Unit of a Tertiary Hospital in Low Resource Setting. A Cohort Study
- ClinicalTrials.gov ID
- NCT05591209
- Acronym / sponsor ID
- ICU / IHRERC/052/2022
- Conditions
- Respiratory Failure, Treatment Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Haramaya UnversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 24 Oct 2022 (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.
The study was a retrospective observational cohort where patient medical record review was done and data were gathered on 419 cases. The ICU admission pattern and patient outcome were the primary outcomes presented in the manuscript.
Detailed description
The study was conducted at a teaching University hospital in a low-resource setting retrospectively on admission to ICU over the last five years. samples were selected using a simple random sampling technique to come up with the desired number.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alive and Dead | – | –Following ICU admission patients are followed until discharge with the outcome of alive or dead |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients admitted to ICU of HrU- HFCSH
Key inclusion criteria (2 listed)
- complete medical record
- admission to ICU
Key exclusion criteria (1 listed)
- patients who were transferred or self discharged
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
pattern of admission and outcome of patients admitted to the Intensive care Unit of a tertiary hospital in Low resource setting. A cohort study
Time frame: 1 month
a retrospective cohort study
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 28 Feb 2024.
- Individual participant dataSharing planned: No. IPD will not be exposed
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Treatment Outcome, run by Haramaya Unversity at 2 sites in Ethiopia.
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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. 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?
pattern of admission and outcome of patients admitted to the Intensive care Unit of a tertiary hospital in Low resource setting. A cohort study (time frame: 1 month). 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 28 Feb 2024.