Fluid ResponsivenessNCT06063993
Evaluation of Perfusion Index Change Post Passive Leg Raising for Fluid Responsiveness in Critically Ill
An observational study of Fluid Responsiveness, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
Peripheral Perfusion Index (PI) has been investigated for its use in hemodynamic monitoring. The PI is derived from the photoelectric plethysmographic signal of the pulse oximeter. The changes in the PI reflect changes in peripheral vasomotor tone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2023to 18 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be subdivided into two groups; responders and non-responder: * Responders group 1 (R); were defined as those who had increase of 10% in CO from baseline measured by EC after PLR. * Non-responders group 2 (NR); those who had increase of less than 10% in CO from baseline measured by EC after PLR.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pulse-oximetry Derived Perfusion Index Change Post Passive Leg Raising for Fluid Responsiveness in Critically Ill Patients
Peripheral Perfusion Index (PI) has been investigated for its use in hemodynamic monitoring. The PI is derived from the photoelectric plethysmographic signal of the pulse oximeter. The changes in the PI reflect changes in peripheral vasomotor tone.
In critically ill patients, the same value was found to represent a very sensitive cutoff point for determining abnormal peripheral perfusion, as defined by a prolonged Capillary Refill Time (CRT). However, age, gender, and ambient temperature have all been shown to affect the measure of CRT in normal volunteers, and the presence of a CRT > 2 or 3 seconds was not predictive of blood loss in phlebotomized volunteers. In addition, the CRT has been shown to have poor intra-observer agreement when a cutoff a two seconds was used in adult emergency room patients.13 Therefore, PI can be used for monitoring peripheral perfusion in critically ill patients.14PI shows the perfusion status of the tissue in the applied area for an instant and a certain time interval. The PI value ranges from 0.02% (very weak) to 20% (strong).
Read more
As non-invasive CO monitors (ICON ®) is not available in many centers in our country due to its high cost, we try to validate other simple non-invasive method to be used to assess FR in critically ill patients.
The purpose of this study is to investigate the efficacy of pulse-oximeter derived PI measurement in assessment of fluid responsiveness in critically ill patients in comparison with CO response.
Read the detailed description
After approval by NHTMRI-IRB Ethical Committee.All demographic data will be obtained including the patients age, sex,associated co-morbidities (diabetes mellitus \& hypertension).
Continuous blood pressure, continuous electrocardiogram, heart rate (HR), and SpO2 (measured by pulse oximetry).
Patients who are eligible and have signs of hemodynamic instability, PLR will be performed by adjusting the bed and not by manually raising the patient's legs. Bronchial secretions must be carefully aspirated before PLR. If awake, the patient should be informed of what the test involves.PLR should start from the semi-recumbent and not the supine position. Adding trunk lowering tosupine position and leg raisingfor 45° for 60 seconds, this mobilizes venous blood from the large splanchnic compartment, thus magnifying the increasing effects of leg elevation on cardiac preload.18COand PI measurements will be recorded in the same patients.
- Conditions
- Fluid Responsiveness
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
to detect reliability of PI to detect Fluid responsiveness (FR) in critically ill patients
Measured: during PLR passive leg raising during 60 seconds
Secondary outcomes (1)
PI reliability
obtain the sensitivity and specificity of this index for FR.
Measured: by the end of statistical analysis of the study up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start28 Aug 2023
- Primary completion30 May 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ICU, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063993
- Sponsor's protocol ID
- 27-2023
- Status last verified
- Jun 2025
- First submitted
- 28 Aug 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulse-oximetry Derived Perfusion Index Change Post Passive Leg Raising for Fluid Responsiveness in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06063993
- Acronym / sponsor ID
- 27-2023
- Conditions
- Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 3 Oct 2023 (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.
Peripheral Perfusion Index (PI) has been investigated for its use in hemodynamic monitoring. The PI is derived from the photoelectric plethysmographic signal of the pulse oximeter. The changes in the PI reflect changes in peripheral vasomotor tone.
In critically ill patients, the same value was found to represent a very sensitive cutoff point for determining abnormal peripheral perfusion, as defined by a prolonged Capillary Refill Time (CRT). However, age, gender, and ambient temperature have all been shown to affect the measure of CRT in normal volunteers, and the presence of a CRT > 2 or 3 seconds was not predictive of blood loss in phlebotomized volunteers. In addition, the CRT has been shown to have poor intra-observer agreement when a cutoff a two seconds was used in adult emergency room patients.13 Therefore, PI can be used for monitoring peripheral perfusion in critically ill patients.14PI shows the perfusion status of the tissue in the applied area for an instant and a certain time interval. The PI value ranges from 0.02% (very weak) to 20% (strong).
As non-invasive CO monitors (ICON ®) is not available in many centers in our country due to its high cost, we try to validate other simple non-invasive method to be used to assess FR in critically ill patients.
The purpose of this study is to investigate the efficacy of pulse-oximeter derived PI measurement in assessment of fluid responsiveness in critically ill patients in comparison with CO response.
Detailed description
After approval by NHTMRI-IRB Ethical Committee.All demographic data will be obtained including the patients age, sex,associated co-morbidities (diabetes mellitus \& hypertension).
Continuous blood pressure, continuous electrocardiogram, heart rate (HR), and SpO2 (measured by pulse oximetry).
Patients who are eligible and have signs of hemodynamic instability, PLR will be performed by adjusting the bed and not by manually raising the patient's legs. Bronchial secretions must be carefully aspirated before PLR. If awake, the patient should be informed of what the test involves.PLR should start from the semi-recumbent and not the supine position. Adding trunk lowering tosupine position and leg raisingfor 45° for 60 seconds, this mobilizes venous blood from the large splanchnic compartment, thus magnifying the increasing effects of leg elevation on cardiac preload.18COand PI measurements will be recorded in the same patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be subdivided into two groups; responders and non-responder: * Responders group 1 (R); were defined as those who had increase of 10% in CO from baseline measured by EC after PLR. * Non-responders group 2 (NR); those who had increase of less than 10% in CO from baseline measured by EC after PLR.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fluid responsiveness
Time frame: during PLR passive leg raising during 60 seconds
to detect reliability of PI to detect Fluid responsiveness (FR) in critically ill patients
1 secondary outcome
PI reliability
Time frame: by the end of statistical analysis of the study up to one year
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 26 Jun 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 Fluid Responsiveness, run by National Hepatology & Tropical Medicine Research Institute 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 11 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 26 Jun 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?
Fluid responsiveness (time frame: during PLR passive leg raising during 60 seconds). 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 26 Jun 2025.