NCT06730087

Brief Summary

Assessment of validity of electrical cardiometry (EC) to measure fluid responsiveness and extravascular lung water that is expressed in the form of (thoracic fluid content) .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

November 6, 2024

Last Update Submit

December 10, 2024

Conditions

Keywords

cardiometry

Outcome Measures

Primary Outcomes (1)

  • electric cardiometry effectiveness in fluid management in critically ill patient

    compairing fluid responsiveness by stroke vloume variation in carddiometry( Fluid responsiveness was defined as SVV \>10% to 15%) and IVC destinsability index by ultrasound (fluid rspnisveness was defined as \[(maximum IVC diameter on inspiration-minimum diameter on expiration)/minimum diameter on expiration\] \> 18%). compairing pulmonary edema by fluid thoracic content(normal range:25 to 35) in cardiometry and B lines in chest ultrasound(more than 3 b-lines in all 4 fields/BLUE points considered positive for pulmonary edema according to BLUE protocol).

    baseline

Study Arms (1)

2 groups which will compare cardiometry with ultrasound

patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted in Assiut University Hospital, in respiratory intensive care unit. This study is a cross sectional design for Extravascular lung water and fluid responsiveness assessment in critically ill patient

You may qualify if:

  • Patients who are 18 years old or more.
  • patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content).

You may not qualify if:

  • Patients less than 18 years old.
  • Patients who refuse to participate in the study.
  • eria:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

faculty of mdicine Assiut university

Asyut, Asyut Governorate, 71111, Egypt

Location

faculty of medicine Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mostafa Mahmoud Attia

CONTACT

samiaa hamdy sadek, professr

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant

Study Record Dates

First Submitted

November 6, 2024

First Posted

December 12, 2024

Study Start

December 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations