Weaning FailureNCT06674824
Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction
An observational study of Weaning Failure, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Weaning Failure
- What is being tested?
- massimo
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2024to 28 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: intubated mechanically ventilated patients candidate for extubation
Who may be able to join
- Intubation and mechanical ventilation
- Fulfilling criteria for extubation
- Fraction inspired oxygen less than 50%
Who cannot join
- a. Hemodynamic instability b. b. tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- massimo
- Keywords
- Massimo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massimoDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Secondary outcomes (2)
Sensitivity of trend of changes in hemoglobin by Massimo to detect WIPO and
Measured: 1 hour
time in minutes between rise of hemoglobin and clinical diagnosis of WIPO
minutes between rise of blood hemoglobin concentration measured by Massimo and clinical diagnosis of WIPO
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start25 Oct 2024
- Primary completion18 Mar 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Fouad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674824
- Sponsor's protocol ID
- FMASU R238/2024
- Status last verified
- Jul 2025
- First submitted
- 28 Oct 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction
- ClinicalTrials.gov ID
- NCT06674824
- Acronym / sponsor ID
- FMASU R238/2024
- Conditions
- Weaning Failure
- Keywords
- Massimo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- intubated mechanically ventilated patients candidate for extubation
Key inclusion criteria (3 listed)
- Intubation and mechanical ventilation
- Fulfilling criteria for extubation
- Fraction inspired oxygen less than 50%
Key exclusion criteria (1 listed)
- a. Hemodynamic instability b. b. tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massimomeasure 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 | Device | – |
Primary outcome
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
2 secondary outcomes
Sensitivity of trend of changes in hemoglobin by Massimo to detect WIPO and
Time frame: 1 hour
time in minutes between rise of hemoglobin and clinical diagnosis of WIPO
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of change PVI in detecting volume responsiveness (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.