Respiratory FailureNCT06291636
Re- Admission Rate Among Survived Patients With Acute Respiratory Failure
An observational study of Respiratory Failure, run by Mansoura University at 1 site in Egypt.
Trial summary
Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- How many people
- 994 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 20 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with acute respiratory failure (either type I or type II)
Who may be able to join
- - Age 18 years or more
- Patient with acute respiratory failure (either type I or type II) who were treated with high flow nasal cannula, non-invasive ventilation or invasive mechanical ventilation
- A readmission event was recorded if the same patient ID was present in the same year; therefore, the follow-up period was different for each patient enrolled
- Readmission is considered early if it occurs within 72 h and late if after 72 h of previous admission in the same hospital.
Who cannot join
- All patient with missed or incomplete data
- All patients died after first admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re- Admission Rate Among Survived Patients With Acute Respiratory Failure in Mansoura University Respiratory ICU : One Year Study
Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry poor prognosis compared to newly admitted ones, in addition to the bad psychological impact for both patient and his family
Read the detailed description
Intensive care unit (ICU) is a place where it can provide the comprehensive life-saving care for the critically ill patients. Once the patients recover from the critical illness, the patients should be discharged from ICU to general ward for further management Hospitalizations in the intensive care unit (ICU) deal with the most critical illnesses and consume a significant portion of medical expenses. Readmission to the ICU, either due to the reoccurrence of a previous disease or an unrelated new illness, results in further consumption of cost and medical resources, and has been proposed as a marker for quality of care .
Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry poor prognosis compared to newly admitted ones, in addition to the bad psychological impact for both patient and his family There is a growing interest in determining the main risk factors related to preventable ICU readmissions as well as in developing predictive tools and alerts to help ICU physicians avoid premature ICU discharges Criteria for ICU admission, discharge, and readmission likely vary dramatically from ICU to ICU and from country to country
Aim of Work:
To study the re- admission rate among survived patients with acute respiratory failure in Mansoura University Respiratory ICU during one year 2023
Study Design:
retrospective study patients and Methods After exclusion of patients with missed data, All consecutive adult (>18 years) and admission to pulmonary critical care unit (PCCU) patients at the Mansoura University Hospital from January 2023 till the end of December 2023 were enrolled in the study
All patients were subjected to:
Demographic data (age and gender), admission severity scoring using acute physiology and chronic health evaluation (APACHE II), type of respiratory failure either hypercapnic respiratory failure type II or hypoxemic respiratory failure type I Glasgow coma scale (GCS), underlying comorbidities including dementia, hypertension, congestive heart failure, stroke, chronic kidney disease, liver cirrhosis, and malignancy, use of steroid, mechanical ventilation (MV) and continuous renal replacement therapy, and organ failure in ICU , time of discharge, cause of ICU readmission were collected A readmission event was recorded if the same patient ID was present in the same year; therefore, the follow-up period was different for each patient enrolled with the longest being 1 year Readmission is considered early if it occurs within 72 h an late after 72 h in the same hospital stay
Statistical analysis:
Data will be analyzed using SPSS (statistical package for social sciences) version 22. Qualitative data will be presented as number and percent, Quantitative data will be tested for normality by Shapiro-Wilk test then described as mean and standard deviation for normally distributed data and median and range for non-normally distributed. The appropriate statistical test will be applied according to data type with the following suggested tests: Chi-Square for categorical variable, Student t test and Mann Whitney test.
Ethical consideration:
Study protocol will be submitted for approval by the institutional research board (IRB), Faculty of Medicine - Mansoura University. The research procedures will be conducted in accordance with the principles of the Declaration of Helsinki. Consent will be obtained from each participant in the study after assuring confidentiality. Patients have the right to withdraw from the study at any point of time during the study without penalty.
- Conditions
- Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital and ICU stay and Cause of readmission
From the database of Mansour university hospital registration, we collect the following data about all adult patients (>18 years) with acute respiratory failure and admitted to Mansoura University chest department and its related ICU with at least one readmission from start of January 2023 till the end of December 2023:
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion20 Jan 2024
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 994 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Awad, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291636
- Sponsor's protocol ID
- R.24.01.2451
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re- Admission Rate Among Survived Patients With Acute Respiratory Failure in Mansoura University Respiratory ICU : One Year Study
- ClinicalTrials.gov ID
- NCT06291636
- Acronym / sponsor ID
- R.24.01.2451
- Conditions
- Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 994 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 4 Mar 2024 (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.
Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry poor prognosis compared to newly admitted ones, in addition to the bad psychological impact for both patient and his family
Detailed description
Intensive care unit (ICU) is a place where it can provide the comprehensive life-saving care for the critically ill patients. Once the patients recover from the critical illness, the patients should be discharged from ICU to general ward for further management Hospitalizations in the intensive care unit (ICU) deal with the most critical illnesses and consume a significant portion of medical expenses. Readmission to the ICU, either due to the reoccurrence of a previous disease or an unrelated new illness, results in further consumption of cost and medical resources, and has been proposed as a marker for quality of care .
Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry poor prognosis compared to newly admitted ones, in addition to the bad psychological impact for both patient and his family There is a growing interest in determining the main risk factors related to preventable ICU readmissions as well as in developing predictive tools and alerts to help ICU physicians avoid premature ICU discharges Criteria for ICU admission, discharge, and readmission likely vary dramatically from ICU to ICU and from country to country
Aim of Work:
To study the re- admission rate among survived patients with acute respiratory failure in Mansoura University Respiratory ICU during one year 2023
Study Design:
retrospective study patients and Methods After exclusion of patients with missed data, All consecutive adult (>18 years) and admission to pulmonary critical care unit (PCCU) patients at the Mansoura University Hospital from January 2023 till the end of December 2023 were enrolled in the study
All patients were subjected to:
Demographic data (age and gender), admission severity scoring using acute physiology and chronic health evaluation (APACHE II), type of respiratory failure either hypercapnic respiratory failure type II or hypoxemic respiratory failure type I Glasgow coma scale (GCS), underlying comorbidities including dementia, hypertension, congestive heart failure, stroke, chronic kidney disease, liver cirrhosis, and malignancy, use of steroid, mechanical ventilation (MV) and continuous renal replacement therapy, and organ failure in ICU , time of discharge, cause of ICU readmission were collected A readmission event was recorded if the same patient ID was present in the same year; therefore, the follow-up period was different for each patient enrolled with the longest being 1 year Readmission is considered early if it occurs within 72 h an late after 72 h in the same hospital stay
Statistical analysis:
Data will be analyzed using SPSS (statistical package for social sciences) version 22. Qualitative data will be presented as number and percent, Quantitative data will be tested for normality by Shapiro-Wilk test then described as mean and standard deviation for normally distributed data and median and range for non-normally distributed. The appropriate statistical test will be applied according to data type with the following suggested tests: Chi-Square for categorical variable, Student t test and Mann Whitney test.
Ethical consideration:
Study protocol will be submitted for approval by the institutional research board (IRB), Faculty of Medicine - Mansoura University. The research procedures will be conducted in accordance with the principles of the Declaration of Helsinki. Consent will be obtained from each participant in the study after assuring confidentiality. Patients have the right to withdraw from the study at any point of time during the study without penalty.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with acute respiratory failure (either type I or type II)
Key inclusion criteria (4 listed)
- - Age 18 years or more
- Patient with acute respiratory failure (either type I or type II) who were treated with high flow nasal cannula, non-invasive ventilation or invasive mechanical ventilation
- A readmission event was recorded if the same patient ID was present in the same year; therefore, the follow-up period was different for each patient enrolled
- Readmission is considered early if it occurs within 72 h and late if after 72 h of previous admission in the same hospital.
Key exclusion criteria (2 listed)
- All patient with missed or incomplete data
- All patients died after first admission
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
Length of hospital and ICU stay and Cause of readmission
Time frame: 1 year
From the database of Mansour university hospital registration, we collect the following data about all adult patients (>18 years) with acute respiratory failure and admitted to Mansoura University chest department and its related ICU with at least one readmission from start of January 2023 till the end of December 2023:
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 4 Mar 2024.
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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 Respiratory Failure, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 2 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 4 Mar 2024. 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 Egypt. 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?
Length of hospital and ICU stay and Cause of readmission (time frame: 1 year). 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 4 Mar 2024.