Hemodynamic Monitoring and Correlation Between Electrical Cardiometry and Esophageal Doppler in Patients Undergoing Major Abdominal Surgery

NCT04255550 | Completed DMC

• 1 other identifier: Hemodynamic monitoring
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Electrical Cardiometry VS Esophageal Doppler

Outcome Measures

Primary Outcomes (1)

• Cardiac Output measurement

  Correlation between two devices regarding Cardiac Output measurement

  24 hours Postoperative

Secondary Outcomes (4)

• Cardiac Index

  Up to 24 hours

• Stroke Volume

  Up to 24 hours

• Stroke Volume Index

  Up to 24 hours

• Syetemic Vascular Resestance

  Up to 24 hours

Interventions

Esophageal doppler DIAGNOSTIC_TEST

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.

Also known as: Electrical cardiometry

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead
• Theodor Bilharz Research Institute: collaborator

Study Sites (1)

Tarek Kaddah

Cairo, 11451, Egypt

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Ahmed Abdalla Mohamed, M.D

  Cairo University

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: April 9, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 30, 2020
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

EG (1)