Mechanically Ventilated PatientsNCT03800849
Mechanical Ventilation Practices in Uganda's Intensive Care Units
An observational study of Mechanically Ventilated Patients, run by Makerere University at 1 site in Uganda.
Trial summary
A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients
- How many people
- 214 participants
- Where
- 1 siteUganda
- Study dates
- 14 Aug 2018to 30 Apr 2019
- 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: Mechanically ventilated Adult patients in four selected ICUs during the study period who meet the inclusion criteria.
Who may be able to join
- All adult patients 18 years and above, initiated on mechanical ventilation, admitted into study ICU during the study period
Who cannot join
- Patients ventilated in another ICU for more than 24 hours and transferred to study ICUs
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mulago hospital
Kampala, 256
Ponsiano Ocama, PHD, 0772421190 ext. 256, ponsiano.ocama@gmail.com
About this study
Official title: Mechanical Ventilation Practices and 28-day Patient Mortality in Uganda's Intensive Care Units: A Prospective Cohort Study
A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Patients will then be followed up for death / discharge within 28 days in ICU.
Read the detailed description
Background: The need for mechanical ventilation is one of the commonest indication for admission to the ICU. Despite the clear benefits of mechanical ventilation, it may be detrimental to the patient if poorly carried out. This has led to a renewed impetus in employing lung protective ventilation strategies, Ventilator Associated Events (VAE) prevention strategies, and safe and appropriate weaning methods to reduce mortality among mechanically ventilated patients. However, there is paucity of data regarding these practices in low-income settings.
Objective: To describe the mechanical ventilation practices, mortality rate and associated factors among mechanically ventilated patients in Uganda's intensive care units.
Methodology: A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Patients will then be followed up for death / discharge within 28 days in ICU.
Data analysis: The primary outcome is all-cause mortality during ICU stay. Data will be summarised into means and standard deviations, medians and interquartile ranges and presented in tables, charts, cross-tabulations and graphs. Univariate and multivariate logistic regression will be used to determine factors associated with mortality.
Utility of results: The results from this study will be disseminated to the Ministry of Health and Makerere University in order to plan, standardise and form guidelines regarding mechanical ventilation practices in ICUs in Uganda.
- Conditions
- Mechanically Ventilated Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day ICU mortality of mechanically ventilated patients
Patients will be followed up either to discharge or death in ICU to a maximum of 28 days
Measured: 7 months
Secondary outcomes (1)
Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions
At discharge, death or at the end of 28 days, the duration of mechanical ventilation, ventilatory settings used and complementary interventions will be described.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start14 Aug 2018
- Primary completion14 Mar 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies 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
- Prospective
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Kyamummi, MBChB, Principal investigator, Makerere University, Kampala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800849
- Sponsor's protocol ID
- Ventilation
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation Practices and 28-day Patient Mortality in Uganda's Intensive Care Units: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03800849
- Acronym / sponsor ID
- Ventilation
- Conditions
- Mechanically Ventilated Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 14 Mar 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 11 Jan 2019 (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.
A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Patients will then be followed up for death / discharge within 28 days in ICU.
Detailed description
Background: The need for mechanical ventilation is one of the commonest indication for admission to the ICU. Despite the clear benefits of mechanical ventilation, it may be detrimental to the patient if poorly carried out. This has led to a renewed impetus in employing lung protective ventilation strategies, Ventilator Associated Events (VAE) prevention strategies, and safe and appropriate weaning methods to reduce mortality among mechanically ventilated patients. However, there is paucity of data regarding these practices in low-income settings.
Objective: To describe the mechanical ventilation practices, mortality rate and associated factors among mechanically ventilated patients in Uganda's intensive care units.
Methodology: A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and above initiated on mechanical ventilation will be recruited. Patients' data will be collected from the files and charts at initiation of mechanical ventilation. Patients will then be followed up for death / discharge within 28 days in ICU.
Data analysis: The primary outcome is all-cause mortality during ICU stay. Data will be summarised into means and standard deviations, medians and interquartile ranges and presented in tables, charts, cross-tabulations and graphs. Univariate and multivariate logistic regression will be used to determine factors associated with mortality.
Utility of results: The results from this study will be disseminated to the Ministry of Health and Makerere University in order to plan, standardise and form guidelines regarding mechanical ventilation practices in ICUs in Uganda.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated Adult patients in four selected ICUs during the study period who meet the inclusion criteria.
Key inclusion criteria (1 listed)
- All adult patients 18 years and above, initiated on mechanical ventilation, admitted into study ICU during the study period
Key exclusion criteria (1 listed)
- Patients ventilated in another ICU for more than 24 hours and transferred to study ICUs
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
28 day ICU mortality of mechanically ventilated patients
Time frame: 7 months
Patients will be followed up either to discharge or death in ICU to a maximum of 28 days
1 secondary outcome
Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
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Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
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Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
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Diaphragm Training Ultrasound
DIAPHRAGM -Ultrasound -Weaning -Mechanical Ventilation
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.
Irene Kyamummi, MBChB principal investigator
Makerere University, Kampala
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 Mechanically Ventilated Patients, run by Makerere University at 1 site in Uganda.
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 11 Jan 2019. 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 Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Kyamummi, MBChB (701 833 144 ext. 256, ikyamummi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day ICU mortality of mechanically ventilated patients (time frame: 7 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 11 Jan 2019.