NCT04112420

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

January 30, 2020

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 25, 2019

Last Update Submit

January 28, 2020

Conditions

Outcome Measures

Primary Outcomes (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)

    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

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

Study Arms (1)

Group A

OTHER

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

Diagnostic Test: Trans-esophageal echocardiography

Interventions

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.

Group A

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 171515, Egypt

RECRUITING

Study Officials

  • Mohamed Abdelsalam, Master

    Vivantes Auguste-Viktoria-Klinikum

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Klany Ali Abdelsalam, Master

CONTACT

Ragaa Ahmed Herdan, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 200 patients \> 60 years with unplanned admission to the intensive care unit are to be included in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 2, 2019

Study Start

October 1, 2019

Primary Completion

March 1, 2021

Study Completion

March 31, 2021

Last Updated

January 30, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations