- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04255550
Hemodynamic Monitoring and Correlation Between Electrical Cardiometry and Esophageal Doppler in Patients Undergoing Major Abdominal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11451
- Tarek Kaddah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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:
- T1 baseline: prior to skin incision.
- T2: one hour after induction.
- T3: half an hour after organ resection.
- 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.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Output measurement
Time Frame: 24 hours Postoperative
|
Correlation between two devices regarding Cardiac Output measurement
|
24 hours Postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Index
Time Frame: Up to 24 hours
|
Assessment of other hemodynamic parameter Cardiac Index
|
Up to 24 hours
|
Stroke Volume
Time Frame: Up to 24 hours
|
Assessment of other hemodynamic parameter Stroke Volume
|
Up to 24 hours
|
Stroke Volume Index
Time Frame: Up to 24 hours
|
Assessment of other hemodynamic parameter Stroke Volume Index
|
Up to 24 hours
|
Syetemic Vascular Resestance
Time Frame: Up to 24 hours
|
Assessment of other hemodynamic parameter Syetemic Vascular Resestance
|
Up to 24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tarek Kaddah, M.D, Cairo University
- Principal Investigator: Abla Elhadedy, M.D, Theodor Bilharz Institute
- Principal Investigator: Shady Rady Abdalla, M.D, Cairo University
- Principal Investigator: Ahmed salah abdelazeem elsayed, M.Sc., Theodor Bilharz Institute
- Study Chair: Ahmed Abdalla Mohamed, M.D, Cairo University
- Study Director: Hanan Khafagy, M.D, Theodor Bilharz Institute
- Study Director: Reham Saeed, M.D, Theodor Bilharz Institute
- Study Director: Haitham Abouzeid, M.D, Theodor Bilharz Institute
- Study Director: Ahmed Essam, M.D, Theodor Bilharz Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Hemodynamic monitoring
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Electrical Cardiometry VS Esophageal Doppler
-
Ahmed Abd El-Rahim Abd El-Hamid HammadCompletedElectrical Cardiometry | Ultrasound of IJVEgypt
-
Al-Azhar UniversityCompletedShock | Transthoracic Echocardiography | Electrical Cardiometry | Fluid ResuscitationEgypt
-
Tanta UniversityCompletedSepsis | Fluid Responsiveness | Transthoracic Echocardiography | Electrical Cardiometry | Stoke VolumeEgypt
-
Tanta UniversityNot yet recruitingIntensive Care Unit | Mechanical Ventilation | Lung Ultrasound | Electrical Cardiometry | Thoracic Fluid Content
-
Austrian Society Of Surgical OncologyCompletedQuality of Life | Gastro Esophageal Reflux | Dysphagia | Electrical Stimulation of the Lower Esophageal SphincterAustria
-
Aarne FeldheiserTechnische Universität Berlin; Humboldt-Universität zu Berlin; German Institute... and other collaboratorsCompletedPerioperative Early Tiredness (Acute Fatigue) in Patients With Epithelial Ovarian Cancer (PERISCOPE)Nutrition | Mitochondrial Dysfunction | Electrical Cardiometry | Perioperative Early Tiredness (Acute Fatigue) | BiosignalsGermany
Clinical Trials on Esophageal doppler
-
Ajou University School of MedicineCompleted
-
University Health Network, TorontoCompleted
-
Gabriele Baldini, MD, MSc, Assistant ProfessorCompleted
-
Loma Linda UniversityWayne State University; University of Massachusetts, Worcester; VA Loma Linda...TerminatedSeptic Shock | Severe SepsisUnited States
-
Assistance Publique - Hôpitaux de ParisFresenius Kabi; GAMIDATerminated
-
University of Sao Paulo General HospitalUniversity of Sao PauloCompleted
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, FranceRecruitingBlood Pressure | Surgery | General Anesthesia | Intensive Care | Hemodynamic Instability | Cardiac Output | Interventional Radiology | Organ FailureFrance
-
The Cleveland ClinicCompleted
-
Northeast Scientific, Inc.UnknownAtrial Fibrillation | Cardiac Arrhythmia | Esophageal FistulaUnited States
-
Yonsei UniversityCompletedElective Posterior Lumbar Spinal FusionKorea, Republic of