Electrical Cardiometry VS Esophageal DopplerNCT04255550
Hemodynamic Monitoring and Correlation Between Electrical Cardiometry and Esophageal Doppler in Patients Undergoing Major Abdominal Surgery
An observational study of Electrical Cardiometry VS Esophageal Doppler, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to correlate hemodynamic monitoring between noninvasive Electrical Cardiometry and minimally invasive Esophageal Doppler in patients undergoing major abdominal surgery Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrical Cardiometry VS Esophageal Doppler
- What is being tested?
- Esophageal doppler
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Apr 2019to 30 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Demographic data, hemodynamic parameters as heart rate (HR), and mean arterial blood pressure (MAP), and urine output will be registered. Cardiac data derived from EC and ED including: CO ,cardiac index( CI), SV, stroke volume index( SVI),systemic vasculare resistance (SVR), and oxygen delivery index (DO2I) will be also recorded. Cardiac data will be recorded at the following time: 1. T1 baseline: prior to skin incision. 2. T2: one hour after induction. 3. T3: half an hour after organ resection. 4. T4: at the end of surgical procedure. During arrhythmias or hemodynamic instability, measurements will not be recorded. After the end of surgery, muscle relaxation will be reversed with 0.05 mg/kg neostigmine and 0.02 mg/kg atropine. Postoperative pain relief will be achieved by intravenous administration of 1mg/kg mepridine and 1gm acetaminophen every 12 hours.
Who may be able to join
- Geriatric patients.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Patients listed for elective major abdominal surgery such as (e.g. cancer stomach, colon, bladder, or pancreas).
Who cannot join
- Age <50 years.
- Patients with hemodynamic instability and on inotropes which means ( perfusion failure, represented by clinical features of circulatory shock and advanced heart failure , It may also be defined as 1 or more out-of-range vital sign measurements, such as low blood pressure).
- Coagulopathies (platelet < 100×109/L, PT > 16 s and INR > 1.2).
- History of esophageal pathology.
- Patient needed massive blood transfusion intraoperatively which means replacement of >1 blood volume in 24 hours or >50% of blood volume in 4 hours (adult blood volume is approximately 70 mL/kg).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to correlate hemodynamic monitoring between noninvasive Electrical Cardiometry and minimally invasive Esophageal Doppler in patients undergoing major abdominal surgery
Read the detailed description
Cardiac output (CO) and Stroke Volume (SV) can be used as markers for global cardiovascular functions and can assess fluid responsiveness to ensure adequate tissue perfusion which is one of the essential concerns of anesthestists and intensivists The gold standard is the thermodilution procedure by pulmonary artery catheter (PAC), yet, cannot be considered as a routine owing to potential difficulty and virtual complications The development of safe, simple, minimally invasive or non-invasive techniques which estimate CO, SV and systemic vascular resistance (SVR) without invasive intravascular catheterization or dye injection is important for clinical decision-making and research in anesthesia and critical care medicine Echocardiography in comparison with other Doppler modalities is a potent diagnostic mean that has the superiority above the traditional PAC for both diagnostic precision and rapidity However, the use of echocardiography needs good training and relatively expensive. Another ultrasound based device is Esophageal Doppler(ED) which looks more suitable for prolonged hemodynamic monitoring. This technique is minimally invasive which calculates the blood flow velocity in descending aorta and can determine SV and CO with sound trustworthiness. Such technique needs less training than standard echocardiography or PAC Thoracic Electric Bioimpedance (TEB) is a noninvasive monitoring which correlates differences in thoracic electrical conductivity to thoracic aortic blood volume and flow. It is a simple method for detection of SV, CO, contractility, SVR, and thoracic fluid content (TFC) for continuous monitoring. The results of previous studies comparing impedance cardiography with thermo dilution and other methods like transoesophageal echocardiography (TEE) have been largely inconclusive which may referred to higher thorax fluid content and consequently higher conductivity after surgical procedure To overcome these problems, upgraded computer equipment and advanced algorithms are used in the newer model; electrical cardiometry (EC), that interprets the maximum changes in TEB and can calculate CO accurately in adults and neonates Although other study compared between two devices in patients undergoing major abdominal and pelvic surgeries , but the sample size was small rather than our study , also it included laparoscopic surgeries which affect hemodynamics (blood pressure , heart rate and other cardiac parameters ) in such points . In addition investigators used the old version of thoracic bio-impedance (NICOM) which is different from our device as we will us (ICON) , Like another study comparing between two devices used also the old version of thoracic bio-impedance and didn't specify the type of surgery at which the study was done . There are also other studies comparing the two devices one of them in paediatrics undergoing kasai operation and the second in patients during liver transplantation , these two studies contain two types of patients not included in the present study .
- Being tested
- Esophageal doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal dopplerDiagnostic test
Also called Electrical cardiometry
It is a prospective observational clinical study to correlate hemodynamic monitoring between non-invasive Electrical Cardiometry and minimally invasive Esophageal Doppler during major abdominal surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output measurement
Correlation between two devices regarding Cardiac Output measurement
Measured: 24 hours Postoperative
Secondary outcomes (4)
Cardiac Index
Assessment of other hemodynamic parameter Cardiac Index
Measured: Up to 24 hours
Stroke Volume
Assessment of other hemodynamic parameter Stroke Volume
Measured: Up to 24 hours
Stroke Volume Index
Assessment of other hemodynamic parameter Stroke Volume Index
Measured: Up to 24 hours
Syetemic Vascular Resestance
Assessment of other hemodynamic parameter Syetemic Vascular Resestance
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start9 Apr 2019
- Primary completion15 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical Cardiometry VS Esophageal DopplerStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Tarek Kaddah, M.D, Principal investigator, Cairo UniversityAbla Elhadedy, M.D, Principal investigator, Theodor Bilharz InstituteShady Rady Abdalla, M.D, Principal investigator, Cairo UniversityAhmed salah abdelazeem elsayed, M.Sc., Principal investigator, Theodor Bilharz InstituteAhmed Abdalla Mohamed, M.D, Study chair, Cairo UniversityHanan Khafagy, M.D, Study director, Theodor Bilharz InstituteReham Saeed, M.D, Study director, Theodor Bilharz InstituteHaitham Abouzeid, M.D, Study director, Theodor Bilharz Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255550
- Sponsor's protocol ID
- Hemodynamic monitoring
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till Publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Monitoring and Correlation Between Electrical Cardiometry and Esophageal Doppler in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04255550
- Acronym / sponsor ID
- Hemodynamic monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 5 Feb 2020 (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.
The aim of this study is to correlate hemodynamic monitoring between noninvasive Electrical Cardiometry and minimally invasive Esophageal Doppler in patients undergoing major abdominal surgery
Detailed description
Cardiac output (CO) and Stroke Volume (SV) can be used as markers for global cardiovascular functions and can assess fluid responsiveness to ensure adequate tissue perfusion which is one of the essential concerns of anesthestists and intensivists The gold standard is the thermodilution procedure by pulmonary artery catheter (PAC), yet, cannot be considered as a routine owing to potential difficulty and virtual complications The development of safe, simple, minimally invasive or non-invasive techniques which estimate CO, SV and systemic vascular resistance (SVR) without invasive intravascular catheterization or dye injection is important for clinical decision-making and research in anesthesia and critical care medicine Echocardiography in comparison with other Doppler modalities is a potent diagnostic mean that has the superiority above the traditional PAC for both diagnostic precision and rapidity However, the use of echocardiography needs good training and relatively expensive. Another ultrasound based device is Esophageal Doppler(ED) which looks more suitable for prolonged hemodynamic monitoring. This technique is minimally invasive which calculates the blood flow velocity in descending aorta and can determine SV and CO with sound trustworthiness. Such technique needs less training than standard echocardiography or PAC Thoracic Electric Bioimpedance (TEB) is a noninvasive monitoring which correlates differences in thoracic electrical conductivity to thoracic aortic blood volume and flow. It is a simple method for detection of SV, CO, contractility, SVR, and thoracic fluid content (TFC) for continuous monitoring. The results of previous studies comparing impedance cardiography with thermo dilution and other methods like transoesophageal echocardiography (TEE) have been largely inconclusive which may referred to higher thorax fluid content and consequently higher conductivity after surgical procedure To overcome these problems, upgraded computer equipment and advanced algorithms are used in the newer model; electrical cardiometry (EC), that interprets the maximum changes in TEB and can calculate CO accurately in adults and neonates Although other study compared between two devices in patients undergoing major abdominal and pelvic surgeries , but the sample size was small rather than our study , also it included laparoscopic surgeries which affect hemodynamics (blood pressure , heart rate and other cardiac parameters ) in such points . In addition investigators used the old version of thoracic bio-impedance (NICOM) which is different from our device as we will us (ICON) , Like another study comparing between two devices used also the old version of thoracic bio-impedance and didn't specify the type of surgery at which the study was done . There are also other studies comparing the two devices one of them in paediatrics undergoing kasai operation and the second in patients during liver transplantation , these two studies contain two types of patients not included in the present study .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Demographic data, hemodynamic parameters as heart rate (HR), and mean arterial blood pressure (MAP), and urine output will be registered. Cardiac data derived from EC and ED including: CO ,cardiac index( CI), SV, stroke volume index( SVI),systemic vasculare resistance (SVR), and oxygen delivery index (DO2I) will be also recorded. Cardiac data will be recorded at the following time: 1. T1 baseline: prior to skin incision. 2. T2: one hour after induction. 3. T3: half an hour after organ resection. 4. T4: at the end of surgical procedure. During arrhythmias or hemodynamic instability, measurements will not be recorded. After the end of surgery, muscle relaxation will be reversed with 0.05 mg/kg neostigmine and 0.02 mg/kg atropine. Postoperative pain relief will be achieved by intravenous administration of 1mg/kg mepridine and 1gm acetaminophen every 12 hours.
Key inclusion criteria (3 listed)
- Geriatric patients.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Patients listed for elective major abdominal surgery such as (e.g. cancer stomach, colon, bladder, or pancreas).
Key exclusion criteria (5 listed)
- Age <50 years.
- Patients with hemodynamic instability and on inotropes which means ( perfusion failure, represented by clinical features of circulatory shock and advanced heart failure , It may also be defined as 1 or more out-of-range vital sign measurements, such as low blood pressure).
- Coagulopathies (platelet < 100×109/L, PT > 16 s and INR > 1.2).
- History of esophageal pathology.
- Patient needed massive blood transfusion intraoperatively which means replacement of >1 blood volume in 24 hours or >50% of blood volume in 4 hours (adult blood volume is approximately 70 mL/kg).
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 |
|---|---|---|
| Esophageal dopplerAlso: Electrical cardiometryIt is a prospective observational clinical study to correlate hemodynamic monitoring between non-invasive Electrical Cardiometry and minimally invasive Esophageal Doppler during major abdominal surgery. | Diagnostic test | – |
Primary outcome
Cardiac Output measurement
Time frame: 24 hours Postoperative
Correlation between two devices regarding Cardiac Output measurement
4 secondary outcomes
Cardiac Index
Time frame: Up to 24 hours
Stroke Volume
Time frame: Up to 24 hours
Stroke Volume Index
Time frame: Up to 24 hours
Syetemic Vascular Resestance
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided. Till Publication
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.
Tarek Kaddah, M.D principal investigator
Cairo University
Abla Elhadedy, M.D principal investigator
Theodor Bilharz Institute
Shady Rady Abdalla, M.D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrical Cardiometry VS Esophageal Doppler, run by Cairo 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 19 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output measurement (time frame: 24 hours Postoperative). 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 19 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.