Intraoperative MonitoringNCT06624891
Interest of the Pleth Variability Index in Neurosurgery
A study testing perioperative fluid responsiveness with the Pleth variability index and perioperative fluid responsiveness with delta PP in people with Intraoperative Monitoring and Hypovolemia, run by National Institute of Neurology, Tunisia at 1 site in Tunisia.
Trial summary
This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults. The main question it aims to answer is: Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Monitoring, Hypovolemia, Fluid Challenge
- What is being tested?
- perioperative fluid responsiveness with the Pleth variability index and perioperative fluid responsiveness with delta PP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2023to 19 Aug 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients proposed for intracranial surgery
- Must be aged 18 and over
- Must be classified as ASA I, ASA II, and ASA III according to the American Society of Anesthesiologists classification
Who cannot join
- Non-consenting patients
- Patients classified ASA IV or higher
- Cardiac arrhythmia
- Heart disease with left ventricular ejection fraction less than 45%
- Obesity with a BMI greater than 40 Kg/m2.
- Peripheral vascular disease
Show all 12Show fewer
- Severe lung disease
- End-stage renal disease
- Intraoperative cardiac arrhythmia
- The occurrence of cardiac arrest
- The occurrence of hemorrhagic shock
- Intraoperative use of low tidal volumes or high respiratory rates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Perioperative Fluid Responsiveness in Neurosurgery: Interest of the Pleth Variability Index
This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults.
The main question it aims to answer is:
- Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth variability index to dela PP to see if it predicts fluid responsiveness in neurosurgery.
Once participants give their consent, they will be randomly assigned to one of two groups. In one group, fluid responsiveness will be monitored using the Pleth Variability Index, while in the other group, it will be monitored using delta PP.
- Conditions
- Intraoperative Monitoring, Hypovolemia, Fluid Challenge
- Being tested
- perioperative fluid responsiveness with the Pleth variability index, perioperative fluid responsiveness with delta PP
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perioperative fluid responsiveness with the Pleth variability indexOther
Perioperative fluid challenge and responsiveness will be based on monitoring the pleth variability index. In fact, volemia will be estimated with the PVI.
perioperative fluid responsiveness with delta PPOther
fluid challenge and responsiveness during intervention will be based on monitoring delta PP.
| Study group | Role | What they receive |
|---|---|---|
| pleth variability index (PVI) | Experimental | Participants will be monitored during the intervention using a Radical-7 Pulse CO-Oximeter to instantly determine the pleth variability index (PVI). If the PVI is more than 14% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes. Receives: Other: perioperative fluid responsiveness with the Pleth variability index |
| delta PP | Active comparator | Participants will be monitored during the intervention using arterial catheter to instantly determine delta PP. If Delta PP is more than 13% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes. Receives: Other: perioperative fluid responsiveness with delta PP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of PVI in fluid responsiveness in neurosurgery
Investigate the value of the plethysmographic variability index (PVI) in assessing the response to perioperative vascular filling in neurosurgery.
Measured: chanfe of PVI value from baseline to a value more than 14% and untill the end of surgery
Secondary outcomes (4)
Amount of fluids administered intraoperatively
Measured: during the surgery
Renal, metabolic and hydroelectrolytic repercussions.
Measured: up to the first 24 hours postoperatively
Length of postoperative stay
Measured: up to hospital discharge, an average of 4 days
Incidence of post-operative complications
Measured: up to hospital discharge, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Mar 2023
- Primary completion30 Jun 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative MonitoringStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective comparative randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurology, Tunisia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hammami Rabeb, National Institute of Neurology, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624891
- Sponsor's protocol ID
- PVI IN NEUROSURGERY
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Fluid Responsiveness in Neurosurgery: Interest of the Pleth Variability Index
- ClinicalTrials.gov ID
- NCT06624891
- Acronym / sponsor ID
- PVI IN NEUROSURGERY
- Conditions
- Intraoperative Monitoring, Hypovolemia, Fluid Challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Institute of Neurology, TunisiaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 3 Oct 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.
This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults.
The main question it aims to answer is:
- Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth variability index to dela PP to see if it predicts fluid responsiveness in neurosurgery.
Once participants give their consent, they will be randomly assigned to one of two groups. In one group, fluid responsiveness will be monitored using the Pleth Variability Index, while in the other group, it will be monitored using delta PP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective comparative randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| pleth variability index (PVI) | Experimental | Other: perioperative fluid responsiveness with the Pleth variability indexParticipants will be monitored during the intervention using a Radical-7 Pulse CO-Oximeter to instantly determine the pleth variability index (PVI). If the PVI is more than 14% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes. |
| delta PP | Active comparator | Other: perioperative fluid responsiveness with delta PPParticipants will be monitored during the intervention using arterial catheter to instantly determine delta PP. If Delta PP is more than 13% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients proposed for intracranial surgery
- Must be aged 18 and over
- Must be classified as ASA I, ASA II, and ASA III according to the American Society of Anesthesiologists classification
Key exclusion criteria (12 listed)
- Non-consenting patients
- Patients classified ASA IV or higher
- Cardiac arrhythmia
- Heart disease with left ventricular ejection fraction less than 45%
- Obesity with a BMI greater than 40 Kg/m2.
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 |
|---|---|---|
| perioperative fluid responsiveness with the Pleth variability indexPerioperative fluid challenge and responsiveness will be based on monitoring the pleth variability index. In fact, volemia will be estimated with the PVI. | Other | pleth variability index (PVI) |
| perioperative fluid responsiveness with delta PPfluid challenge and responsiveness during intervention will be based on monitoring delta PP. | Other | delta PP |
Primary outcome
Value of PVI in fluid responsiveness in neurosurgery
Time frame: chanfe of PVI value from baseline to a value more than 14% and untill the end of surgery
Investigate the value of the plethysmographic variability index (PVI) in assessing the response to perioperative vascular filling in neurosurgery.
4 secondary outcomes
Amount of fluids administered intraoperatively
Time frame: during the surgery
Renal, metabolic and hydroelectrolytic repercussions.
Time frame: up to the first 24 hours postoperatively
Length of postoperative stay
Time frame: up to hospital discharge, an average of 4 days
Incidence of post-operative complications
Time frame: up to hospital discharge, an average of 4 days
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 3 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing perioperative fluid responsiveness with the Pleth variability index and perioperative fluid responsiveness with delta PP in people with Intraoperative Monitoring and Hypovolemia, run by National Institute of Neurology, Tunisia at 1 site in Tunisia.
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 12 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 3 Oct 2024. 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 Tunisia. 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?
Value of PVI in fluid responsiveness in neurosurgery (time frame: chanfe of PVI value from baseline to a value more than 14% and untill the end of surgery). 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 3 Oct 2024.