Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction

July 31, 2025 updated by: Amr Fouad, Ain Shams University

Weaning induced cardiac dysfunction is a common cause of weaning failure in critically ill patients. plethysmography variability index (PVI) is a non-invasive, real-time, and automated parameter for evalu¬ating fluid responsiveness.

By proving the validity of (PVI) in predicting successful spontaneous breathing trial Massimo can be used an easy noninvasive method that help in deciding the right time for weaning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

intubated mechanically ventilated patients candidate for extubation

Description

Inclusion Criteria:

  1. Intubation and mechanical ventilation
  2. Fulfilling criteria for extubation
  3. Fraction inspired oxygen less than 50%

Exclusion Criteria:

  • a. Hemodynamic instability b. b. tracheostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of change PVI in detecting volume responsiveness
Time Frame: 1 hour
accuracy of change PVI in detecting volume responsiveness through measuring limits of agreement , Bias and correlation between PVI and a standard method of measurement which left ventricular outflow tract velocity time integral
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of trend of changes in hemoglobin by Massimo to detect WIPO and
Time Frame: 1 hour
1 hour
time in minutes between rise of hemoglobin and clinical diagnosis of WIPO
Time Frame: 1 hour
minutes between rise of blood hemoglobin concentration measured by Massimo and clinical diagnosis of WIPO
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Actual)

March 18, 2025

Study Completion (Actual)

April 28, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU R238/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Weaning Failure

Clinical Trials on massimo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe