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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Tamer Awad Elsayed

    Al Mansurah, Dakhlia, 050

Other trials in Egypt

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.

Medical subject headings
Respiratory Insufficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted4 Mar 2024
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2023
  4. Study completion20 Jan 2024

Resources

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)
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

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.

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