OutcomeNCT06087939
Outcome and Predictors of Mortality of Patients on Prolonged Mechanical Ventilation
An observational study of Outcome, run by Wollo University.
Trial summary
Prolonged mechanical ventilation (PMV) and weaning failure are factors associated with prolonged hospital length of stay and increased morbidity and mortality. In addition to the individual challenges that stress patients and their families, the resource-intensive care these patients receive places a significant… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcome
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 30 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All charts of critically ill patients admitted to ICU of Dessie comprehensive specialized hospital.
Who may be able to join
- All charts of critically ill patients on prolonged mechanical ventilation in of Dessie Comprehensive Specialized Hospital during the study period.
Who cannot join
- Charts with incomplete information and missing values as well as those that are not available will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcome and Predictors of Mortality of Patients on Prolonged Mechanical Ventilation in Critically Ill Patients: a Multicenter Retrospective Cohort Study
Prolonged mechanical ventilation (PMV) and weaning failure are factors associated with prolonged hospital length of stay and increased morbidity and mortality. In addition to the individual challenges that stress patients and their families, the resource-intensive care these patients receive places a significant burden on the public health system. These burdens often persist over the long term, especially in the case of weaning failure with subsequent home mechanical ventilation (HMV).
This study will provide invaluable and in-depth knowledge of major sources of admission to ICU and will clarify the cause for the outcomes seen after prolonged mechanical ventilation in ICU admission, at Dessie comprehensive Hospital, the result of our study will also serve as a source or baseline information for future valuable researches to be undergone around the subject of interest.
Read the detailed description
The number of patients requiring prolonged mechanical ventilation after acute illness is increasing. Their long-term outcome is poor and has not improved significantly over the past 20 years. The symptom burden for patients is considerable, and family members often suffer from significant physical and emotional strain. Long-term survivors report lasting physical limitations, but their emotional health is generally good. Care for many patients requiring prolonged mechanical ventilation is shifting t post-intensive care unit settings. While this trend has resulted in cost savings for hospitals and payers, it has not had a major impact on patient outcomes.
Patients requiring prolonged mechanical ventilation consume a disproportionate amount of healthcare resources and clinician time. Measurement and knowledge of their outcomes will guide efforts to improve their care.
This study will be conducted in Dessie Comprehensive Specialized Hospital from August 2023 to January 2024. A retrospective cohort study will be conducted. Data will be checked, coded, entered, and analyzed using SPSS version 22 software. Descriptive statistics will be used to summarize data, tables, and figures for display results. Bivariate and multivariate analyses will be used to see the effect of the independent variable on the outcome variable. Variables that are significant on bivariate analysis at a p-value less than 0.2 will be taken to multivariate analysis. In multivariate analysis, a p-value of less than 0.05 will be used as a cut-off point for the presence of association. The strength of the association will be measured by 95% confidence interval and odd ratio.
- Conditions
- Outcome
- Being tested
- Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Mechanical ventilation (MV) is a life support technique that is routinely used in the intensive care units (ICUs) for patients with life-threatening conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcomes of critically ill patients undergoing prolonged mechanical ventilation
Clinical outcome: indicated either patient survived or died at the time of discharge.
Prolonged mechanical ventilation: is defined as successful extubation after more than three spontaneous breathing trials or taking more than 14 days
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Jul 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wollo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Timerga, Wollo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087939
- Sponsor's protocol ID
- PMV
- Status last verified
- Apr 2024
- First submitted
- 29 Sep 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share the individual participant data when asked.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Predictors of Mortality of Patients on Prolonged Mechanical Ventilation in Critically Ill Patients: a Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06087939
- Acronym / sponsor ID
- PMV
- Conditions
- Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Wollo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 18 Oct 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.
Prolonged mechanical ventilation (PMV) and weaning failure are factors associated with prolonged hospital length of stay and increased morbidity and mortality. In addition to the individual challenges that stress patients and their families, the resource-intensive care these patients receive places a significant burden on the public health system. These burdens often persist over the long term, especially in the case of weaning failure with subsequent home mechanical ventilation (HMV).
This study will provide invaluable and in-depth knowledge of major sources of admission to ICU and will clarify the cause for the outcomes seen after prolonged mechanical ventilation in ICU admission, at Dessie comprehensive Hospital, the result of our study will also serve as a source or baseline information for future valuable researches to be undergone around the subject of interest.
Detailed description
The number of patients requiring prolonged mechanical ventilation after acute illness is increasing. Their long-term outcome is poor and has not improved significantly over the past 20 years. The symptom burden for patients is considerable, and family members often suffer from significant physical and emotional strain. Long-term survivors report lasting physical limitations, but their emotional health is generally good. Care for many patients requiring prolonged mechanical ventilation is shifting t post-intensive care unit settings. While this trend has resulted in cost savings for hospitals and payers, it has not had a major impact on patient outcomes.
Patients requiring prolonged mechanical ventilation consume a disproportionate amount of healthcare resources and clinician time. Measurement and knowledge of their outcomes will guide efforts to improve their care.
This study will be conducted in Dessie Comprehensive Specialized Hospital from August 2023 to January 2024. A retrospective cohort study will be conducted. Data will be checked, coded, entered, and analyzed using SPSS version 22 software. Descriptive statistics will be used to summarize data, tables, and figures for display results. Bivariate and multivariate analyses will be used to see the effect of the independent variable on the outcome variable. Variables that are significant on bivariate analysis at a p-value less than 0.2 will be taken to multivariate analysis. In multivariate analysis, a p-value of less than 0.05 will be used as a cut-off point for the presence of association. The strength of the association will be measured by 95% confidence interval and odd ratio.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All charts of critically ill patients admitted to ICU of Dessie comprehensive specialized hospital.
Key inclusion criteria (1 listed)
- All charts of critically ill patients on prolonged mechanical ventilation in of Dessie Comprehensive Specialized Hospital during the study period.
Key exclusion criteria (1 listed)
- Charts with incomplete information and missing values as well as those that are not available will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilationMechanical ventilation (MV) is a life support technique that is routinely used in the intensive care units (ICUs) for patients with life-threatening conditions. | Device | – |
Primary outcome
clinical outcomes of critically ill patients undergoing prolonged mechanical ventilation
Time frame: 5 months
Clinical outcome: indicated either patient survived or died at the time of discharge. Prolonged mechanical ventilation: is defined as successful extubation after more than three spontaneous breathing trials or taking more than 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Yes. The investigators plan to share the individual participant data when asked.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome, run by Wollo University.
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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Timerga (+251925044807, sara24tn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcomes of critically ill patients undergoing prolonged mechanical ventilation (time frame: 5 months). 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 30 Apr 2024.