Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004757

Trial Description

start of 1:1-Block title

Title

Effectiveness of Transthoracic Echocardiography immediately after Cardiac Surgery

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

TrEchoS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study will be undertaken in 110 adult patients immediately following open heart surgery. While being mechanically ventilated on the intensive care unit, patients undergo ultrasonography of the heart and adjacent organs in supine and additionally in left lateral recumbent positions. Ultrasonography is performed with an ultrasonic probe, which is positioned on the left side of the chest wall at certain landmarks close to the apex and the base of the heart (transthoracic echocardiography). Transthoracic echocardiography examinations comply with the requirements of a detailled registration protocol and aim to measure critical parameters, generally accepted to precisely define the functional state of the cardiovascular system. Furthermore, examinations screen for postoperative haemorrhage as a potential source of complication after cardiac surgery. The study rules out: (1) the percentage of post cardiac surgical patients, in whom transthoracic echocardiography is qualified to fully delineate the functional state of the cardiovascular system, and (2) the position of the ultrasonic probe on the chest wall and the body position of the patient (supine versus left lateral recumbent), which are most suitable to gain optimal results.

As the current standard of choice, echocardiography early after cardiac surgery is performed with an ultrasonic probe, which is advanced via mouth, throat and oesophagus into the stomach until it is lying directly behind the heart (transoesophageal echocardiography). In nearly all patients transoesophageal echocardiography provides excellent registrations of the heart, characterised by high image resolution and sound interpretability. However, there are potential risks associated with the technique. Firstly, the upper gastrointestinal tract may suffer damage. Secondly, supplementary administration of opioids and sedatives to the patient is necessary in order to allow for the advancement of the probe, which has a largest diameter of up to 15 mm. Transthoracic echocardiography, on the other hand, is hallmarked by the absence of any side effect. Moreover, its execution is more expeditious, a clear advantage in emergency situations. However, prevailing expert opinion dictates that transthoracic echocardiographic assessment of haemodynamic status is insufficient in cardiac surgical patients, because of several factors, such as the presence of mechanical ventilation, the interposition of the lung between the probe and the heart, the accumulation of air in the mediastinal and pleural spaces, indwelling chest tubes, and obstructive bandages, which interfere adversely with the quality of imaging.

Therefore, the objective of this study is to test the hypothesis that transthoracic echocardiography can significantly impact the cardiac surgical setting by its ability to determine intracardiac haemodynamics noninvasively and to rule out complications from haemorrhage, and that transthoracic echocardiography should replace transoesophageal echocardiography as the method of choice in postoperative cardiac surgical patients.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

BACKGROUND:
Low cardiac output syndrome (LCOS) frequently occurs after cardiac surgery, affecting up to 20% of patients, and substantially contributing to postoperative morbidity and mortality. Early diagnosis, the prerequisite for optimal management, falls within the realm of transesophageal echocardiography (TEE). However, during recent years transthoracic echocardiography (TTE) has gained acceptance as a pivotal tool to assess the integrity of the cardiovascular system. TTE is a potentially less invasive, faster, cheaper and easier to use alternative to TEE, but success rate is considered to be unacceptably low due to severely limited acoustic access. Therefore, this study aimed to define the effectiveness of TTE to diagnose causes of LCOS in ventilated patients after cardiac surgery.

METHODS:
110 consecutive patients are prospectively enrolled in the study. TTE studies are performed on ventilated patients within 4 hours after cardiac surgery. Each patient undergoes TTE in the supine and left lateral decubitus position. TTE examinations are in keeping with a detailed registration protocol, and place particular emphasis on the quantification of basic haemodynamic determinants and the exclusion of bleeding complications.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004757
  •   2014/07/30
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   2013-096-f-N, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Functional status of the cardiovascular system following cardiac surgical procedures
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Group: Transthoracic Echocardiography. In all patientes included in the protocol, study intervention simply consists of transthoracic echocardiography. Transoesophageal echocardiography is not conducted.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Effectivity of transthoracic echocardiography to define the functional status of the cardiovascular system early after cardiac surgery

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/01/01
  •   110
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

previous cardiac surgery, mechanical ventilation

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

none

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieUniversitätsklinikum Münster
    • Mr.  Univ.-Prof. Dr. med.  Alexander  Zarbock 
    • Albert-Schweitzer-Campus 1, Gebäude A1
    • 48149  Münster
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieUniversitätsklinikum Münster
    • Mr.  Priv.-Doz. Dr. med.  Christoph  Schmidt 
    • Albert-Schweitzer-Campus 1, Gebäude A1
    • 48149  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieUniversitätsklinikum Münster
    • Mr.  Priv. Doz. Dr. med.  Christoph  Schmidt 
    • Albert-Schweitzer-Campus 1, Gebäude A1
    • 48149  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieUniversitätsklinikum Münster
    • Mr.  Priv. Doz. Dr. med.  Christoph  Schmidt 
    • Albert-Schweitzer-Campus 1, Gebäude A1
    • 48149  Münster
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieUniversitätsklinikum Münster
    • Mr.  Univ.-Prof. Dr. med.  Alexander  Zarbock 
    • Albert-Schweitzer-Campus 1, Gebäude A1
    • 48149  Münster
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/10/07
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.