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Intensive Care Unit SyndromeNCT04112420

Detection of the Incidence of Pre-existing Cardio-pulmonary Diseases by Using of Echocardiography

A study testing Trans-esophageal echocardiography in people with Intensive Care Unit Syndrome, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Introduction: The uncomplicated and focused transthoracic cardiac ultrasound examination, which is gentle for the patient, gives the doctor in a short time a lot of information about possible, as unrecognized pathologies of the organs of the chest. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Intensive Care Unit Syndrome
What is being tested?
Trans-esophageal echocardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Oct 2019to 31 Mar 2021
Phase
Interventional
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients of both sexes
  • Age: greater than 60 years old
  • Unplanned admission to the intensive care unit
  • The patient's or caregiver's ability to educate
  • Existing approval of the study

Who cannot join

  • Lack of consent
  • Alter < 60 years old
  • • Non-Informable Patient.

Trial locations and contacts

1 site in 1 country.

Mohamed Klany Ali Abdelsalam, Master contact

+4915213709835

mohamedkelany88@gmail.com

Ragaa Ahmed Herdan, M.D contact

+201001741748

ragaanesthesia@yahoo.com

Egypt1 site, 1 recruiting
  • Assiut University Hospital

    Asyut, 171515

    laa Mohamed Ahmed Attia, M.D, +201099923117, alaa.atya@aun.edu.eg

    Nawal Abdel-aziz Jadel-Rab Abdullah, M.D, +201002955960, n.gadelrab@aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Detection of the Incidence of Intensively Medically Relevant Pre-existing Cardio-pulmonary Diseases by Using of Focused Echocardiography Upon Admission to the Intensive Care Unit

Introduction: The uncomplicated and focused transthoracic cardiac ultrasound examination, which is gentle for the patient, gives the doctor in a short time a lot of information about possible, as unrecognized pathologies of the organs of the chest.

Before a patient undergoes a planned procedure or intervention with a subsequent intensive stay, examinations are necessary from which the anesthetist/intensive physician has important information the state of health of the patient. The findings and the information will be used to plan the individual anesthesia procedures and intensive medical management, which is suitable for the patient.

Read more

The aim of this work is to investigate whether the use of a modified examination protocol in patients who need to be admitted to an intensive care unit has an influence on the actions of the intensive care physician. Does the information that is collected from the findings have a complementary influence in the planning of intensive care management? The Study objectives

Primary objectives:

What is the frequency with which pathological changes are detected?

Secondary objectives:

Do the additional findings have an influence on the intensive care procedure?

Read the detailed description

At the end of the 1980s, a protocol for transthoracic cardiac ultrasound examination was established in order to get a quick overview of the structure and function of a patient's heart. Under the abbreviation "FATE" (focus assessed transthoracic echocardiography), it was "FAST"(focused assessment with sonography for trauma) when it was analogous to the ultrasound examination in traumatized patients, became an important component in the care of the acutely ill patients ( Walcher.F et al,2009).

The uncomplicated and focused transthoracic cardiac ultrasound examination, which is gentle for the patient, gives the doctor in a short time a lot of information about possible, as unrecognized pathologies of the organs of the chest.

In 2014, M.T. Bétker et al. published a study on the preoperative transthoracic sonography of the heart. Pathologies were detected in 27 percent of the patients included in the study, that could have a possible influence on the anesthesiological and intensive medical care procedures (Bøtker, M.T et al,2014).

The aim of this work is to investigate whether the use of a modified examination protocol in patients who need to be admitted to an intensive care unit has an influence on the actions of the intensive care physician. Does the information that is collected from the findings have a complementary influence in the planning of intensive care management? Before a patient undergoes a planned procedure or intervention with a subsequent intensive stay, examinations are necessary from which the anesthetist/intensive physician has important information the state of health of the patient. The findings and the information will be used to plan the individual anesthesia procedures and intensive medical management, which is suitable for the patient.

The examination takes place as part of the premedication visit. In addition to the history and the physical examination, the evaluation of already carried out examinations takes place here. Potential risks and complications are also discussed if the patient desires.

This evaluation helps to reduce the perioperative and interventional risks for the patient. particularly the detection of the cardiopulmonary capacity of the patient. Various technical studies can help to diagnose diseases of the heart, lungs and vascular system or to record the course of a known disorder (Anästh. Intensivmed (51) ,2010).

In addition to laboratory examinations, the electrocardiogram, the X-ray examination of the organs of the thorax, the blood vessel sonography, echocardiography is available.

The most common indications of echocardiography are the assessment of left and right ventricular pumping function and the exclusion of cardiac defects and shunt in patients with signs of heart failure or pathological auscultation findings.

These findings will be analyzed latest the day before a planned operation or intervention during the premedication visits and discussed with the patient in order to develop a patient-specific procedure and regimen.

This possibility exists for urgent interventions or interventions that which must be carried out on the same day, only conditionally and not for all planned admissions in the intensive care unit. Completeness of anesthetic and intensive medical findings about a statement the cardiopulmonary function is not always to be expected. In favor of rapid therapy, this must usually be dispensed with in a patient-individual risk-benefit-assessment.

The purpose of this study is to help answer the question whether the routine use of focused transthoracic echocardiography in unplanned admission to the Intensive Care Unit is a useful additional measure for the anesthesiologist and intensive physician in order to provide the patient with more safety?

Being tested
Trans-esophageal echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trans-esophageal echocardiographyDiagnostic test

    The department registers an unplanned admission of a patient to the intensive care unit. The indication is verified again by the intensive care physician.

    In this case, the patient is then admitted to the intensive care unit, supervised by an intensive care physician, orientated and initiated therapeutic and diagnostic measures.

    As part of the planned transthoracic cardiac ultrasound examination, it is then selected whether the patient is suitable according to the patient's will and the inclusion or exclusion criteria.

    After clarification, time to think and consent, the examination is then carried out according to the protocol by approved doctors of the Clinic for Anesthesia, intensive care and pain therapy. Followed by digital storage for the finding.

    After the subsequent operation, the investigator determines whether knowledge of detected pathologies would have an effective influence on the anesthesiological procedure or not.

Study groups in NCT04112420
Study groupRoleWhat they receive
Group AOther200 Participants more than 60 yrs old having Trans-esophageal Echocardiography examination upon admission to ICU
Receives: Diagnostic Test: Trans-esophageal echocardiography

What is being measured

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

  1. Detection the pathological changes and finding of the Heart and the lung by using the Transesophgeal Echocardiography

    Using the Transesophgeal Echocardiography to detect the pathological changes and finding of the Heart and the lung (Percardial effusion in centimeter,pleural effusion in centimeter,ejection fraction in percentage,left ventricular hypertrophy in centimeter)

    Measured: It take over for every patient about 20 minutes to 30 minutes

Secondary outcomes (1)
  1. Correlation between the finding that will be detected by transesophageal Echocardiography (TEE) and the management plan of the patient

    Measured: from the first day of admission in the intensive care up to three days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2019
  2. Study start1 Oct 2019
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion31 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
200 patients \> 60 years with unplanned admission to the intensive care unit are to be included in the study.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04112420
Sponsor's protocol ID
FATE
Status last verified
Sep 2019
First submitted
25 Sep 2019
Last updated
30 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Trans-esophageal echocardiography in people with Intensive Care Unit Syndrome, run by Assiut 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 5 inclusion and 3 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 Jan 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Klany Ali Abdelsalam, Master (+4915213709835, mohamedkelany88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection the pathological changes and finding of the Heart and the lung by using the Transesophgeal Echocardiography (time frame: It take over for every patient about 20 minutes to 30 minutes). 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 Jan 2020.

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