NCT04114474

Brief Summary

The extent focused transthoracic echocardiography when done pre-operatively to patients admitted for elective surgery and suspected to be at risk of cardiac disease specially the geriatric population can affect perioperative anesthetic management of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

September 27, 2019

Last Update Submit

October 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lt. Ventricular EDV

    Transthoracic echocardiography (TEE) LVEDV

    Change from Baseline pre operative LVEDV to first day postoperative

Interventions

TTE (Vivid I echocardiography machine General Electric Healthcare, Milwaukee, WI, USA) with a 3S-RS (1.5-3.6 MHz) transthoracic probe). was done by professional anesthesiologist following the :Hemodynamic Echocardiography Assessment in Real Time ( HEART) protocol. According to the clinical findings of TTE patients may be either free or have one or more of the following haemodynamic states normal, empty, vasodilated ,left ventricular systolic or diastolic failure, left ventricular systolic and diastolic failure, and right ventricular failure, valve stenosis or regurgitation of at least moderate severity

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eligibility for participating in the study was assessed before assignment by the attending physician in the anesthesia clinic . Patients above 60 years of age ASAI and ASA II were included in the study unless history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases were found as theses patients were excluded from the study.

You may qualify if:

  • Patients above 60 years of age ASAI and ASA II were included

You may not qualify if:

  • history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Asyut, 0020, Egypt

Location

Study Officials

  • ALAA A EALZOHRY, MD

    Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University.

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 3, 2019

Study Start

October 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

October 18, 2019

Record last verified: 2019-10

Locations