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OpenTrials
Completed

NCT Number: NCT06674824

Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction

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.

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Key information

Conditions

Weaning Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University hospitals

Cairo, 11591, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • a. Hemodynamic instability b. b. tracheostomy

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 1 hour

  2. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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