Evaluating changes in perfusion index after leg raising in critically ill patients
Evaluation of Pulse-oximetry Derived Perfusion Index Change Post Passive Leg Raising for Fluid Responsiveness in Critically Ill Patients
This study looks at how raising the legs of critically ill patients affects their blood flow and heart function to see if it helps them respond better to fluids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Hepatology & Tropical Medicine Research Institute Government |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06063993 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the changes in Peripheral Perfusion Index (PI) following a Passive Leg Raising (PLR) maneuver in critically ill patients. The study will involve monitoring various hemodynamic parameters, including blood pressure and heart rate, to determine fluid responsiveness. Eligible patients will be those showing signs of hemodynamic instability, and the PLR will be performed in a controlled manner to enhance cardiac preload. Data will be collected to analyze the relationship between PI changes and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are admitted to the intensive care unit and exhibit signs of hemodynamic instability.
Not a fit: Patients with known peripheral vascular disease, severe obesity, or those on multiple vasopressors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the assessment of fluid responsiveness in critically ill patients, leading to better management of their hemodynamic status.
How similar studies have performed: While the use of PI for hemodynamic monitoring has been explored, this specific approach using PLR in critically ill patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subjects are adults aged ≥18 years old * admitted tothe intensive care unit of the National Hepatologyand Tropical Medicine Research Institute (NHTMRI). * Patients with clinical signs of hemodynamic instability i.e. a systolic blood pressure \< 90 mmHg or decrease in systolic blood pressure \> 40 mmHg, signs of organ hypoperfusion as oliguria \< 0.5ml/Kg/hour. Exclusion Criteria: * If there is known peripheral vascular disease * or ≥ 2 vasopressors with the maximum doses * or in the presence of nail polish as readings from pulse oximeter will be distortedin these cases * or if there is contraindication for PLR as uncontrolled hemodynamic status * intracranial hypertension * severe chronic obstructive pulmonary disease * broncho-alveolar fistula * severe emphysema * and those with pre-existing comorbidities including severe left and right ventricular dysfunction, severe pulmonary hypertension * severe obesity (BMI \>40 kg/m2) * pregnancy.
Where this trial is running
Cairo
- Nhtmri — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Eman Ibrahim El-Desoki Mahmoud
- Email: eman18350@gmail.com
- Phone: +201227409501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.