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

Primary Purpose

Intensive Care Unit Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Trans-esophageal echocardiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intensive Care Unit Syndrome

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Assiut University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Group A

Arm Description

200 Participants more than 60 yrs old having Trans-esophageal Echocardiography examination upon admission to ICU

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2019
Last Updated
January 28, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04112420
Brief Title
Detection of the Incidence of Pre-existing Cardio-pulmonary Diseases by Using of Echocardiography
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
200 Participants more than 60 yrs old having Trans-esophageal Echocardiography examination upon admission to ICU
Intervention Type
Diagnostic Test
Intervention Name(s)
Trans-esophageal echocardiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection the pathological changes and finding of the Heart and the lung by using the Transesophgeal Echocardiography
Description
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)
Time Frame
It take over for every patient about 20 minutes to 30 minutes
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Lack of consent Alter < 60 years old • Non-Informable Patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Klany Ali Abdelsalam, Master
Phone
+4915213709835
Email
mohamedkelany88@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ragaa Ahmed Herdan, M.D
Phone
+201001741748
Email
ragaanesthesia@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelsalam, Master
Organizational Affiliation
Vivantes Auguste-Viktoria-Klinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
171515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
laa Mohamed Ahmed Attia, M.D
Phone
+201099923117
Email
alaa.atya@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Nawal Abdel-aziz Jadel-Rab Abdullah, M.D
Phone
+201002955960
Email
n.gadelrab@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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