Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction

NCT06674824 | Completed

• 1 other identifier: FMASU R238/2024
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weaning Failure

Keywords

Massimo

Outcome Measures

Primary Outcomes (1)

• accuracy of change PVI in detecting volume responsiveness

  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 Outcomes (2)

• Sensitivity of trend of changes in hemoglobin by Massimo to detect WIPO and

  1 hour

• time in minutes between rise of hemoglobin and clinical diagnosis of WIPO

  1 hour

Interventions

massimo DEVICE

measure plethysmography variability index in patients on spontaneous trial planning for extubation and evaluate its sensitivity in relation to transthoracic echocardiographic velocity time integral in early detecting weaning induced pulmonary edema

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

intubated mechanically ventilated patients candidate for extubation

You may qualify if:

• Intubation and mechanical ventilation
• Fulfilling criteria for extubation
• Fraction inspired oxygen less than 50%

You may not qualify if:

• a. Hemodynamic instability b. b. tracheostomy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesia, intensive care and pain management

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 5, 2024
• Study Start: October 25, 2024
• Primary Completion: March 18, 2025
• Study Completion: April 28, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

EG (1)