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.
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.
Egypt1 site, 1 recruiting
- 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
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?
- Conditions
- Intensive Care Unit Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Other | 200 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.
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)
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.
- First posted2 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kilany, Assiut University
- Investigators
- Mohamed Abdelsalam, Master, Principal investigator, Vivantes Auguste-Viktoria-Klinikum
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04112420
- Acronym / sponsor ID
- FATE
- Conditions
- Intensive Care Unit Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 2 Oct 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.
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.
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?
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 200 patients > 60 years with unplanned admission to the intensive care unit are to be included in the study.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Diagnostic Test: Trans-esophageal echocardiography200 Participants more than 60 yrs old having Trans-esophageal Echocardiography examination upon admission to ICU |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Lack of consent
- Alter < 60 years old
- • Non-Informable Patient.
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 |
|---|---|---|
| Trans-esophageal echocardiographyThe 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. | Diagnostic test | Group A |
Primary outcome
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
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)
1 secondary outcome
Correlation between the finding that will be detected by transesophageal Echocardiography (TEE) and the management plan of the patient
Time frame: from the first day of admission in the intensive care up to three days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Mohamed Abdelsalam, Master principal investigator
Vivantes Auguste-Viktoria-Klinikum
1 site in 1 country: see every site and its status.
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.