CraniosynostosisPVI-CRANIONCT07657598
Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
An observational study of Craniosynostosis, run by Muzaffer GENCER at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis surgery. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Craniosynostosis
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 6 years
- All sexes
- Child
Study population: Pediatric patients aged 0-6 years who are scheduled to undergo craniosynostosis surgery at Başakşehir Çam and Sakura City Hospital will constitute the study population.
Who may be able to join
- Pediatric patients aged 0 to 6 years
- Patients scheduled to undergo craniosynostosis surgery
- American Society of Anesthesiologists physical status I, II or III
- Written informed consent obtained from the parent or legal guardian
Who cannot join
- Patients older than 6 years
- American Society of Anesthesiologists physical status IV
- Inappropriate preoperative fasting status
- History of significant cardiac, pulmonary or renal disease
- Patients operated at another institution and subsequently transferred to the study center
- Patients with peripheral circulatory impairment
- Withdrawal of consent by the parent or legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam and Sakura City Hospital
Istanbul, Basaksehir, 34480
Muzaffer Gencer, associate professor, +90 212 909 60 00, dr.m.gencer07@gmail.com
About this study
Official title: Association of Pleth Variability Index Monitoring With Intraoperative Hemodynamic Control in Pediatric Craniosynostosis Surgery
This prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis surgery. Patients aged 0-6 years will be monitored intraoperatively using standard anesthesia monitoring together with PVI and PI measurements. Hemodynamic parameters, including systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, blood loss, fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be recorded. The study will assess the association between PVI/PI changes and intraoperative hemodynamic status, bleeding and transfusion requirements.
Read the detailed description
Craniosynostosis surgery in pediatric patients is associated with a high risk of intraoperative blood loss and hemodynamic instability. Because children have a relatively low circulating blood volume, early detection of intravascular volume changes is essential for maintaining adequate perfusion and preventing hypotension. Goal-directed fluid management may improve oxygen delivery and overall hemodynamic stability during major surgical procedures.
Pleth variability index (PVI) is a noninvasive dynamic parameter derived from pulse oximetry waveform analysis and reflects respiratory variations in the perfusion index (PI). PI and PVI may provide useful information regarding peripheral perfusion, volume status and fluid responsiveness during mechanical ventilation. However, data regarding the utility of these parameters in pediatric craniosynostosis surgery are limited.
In this prospective observational study, pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. PVI and PI values will be recorded at predefined time points during surgery together with standard hemodynamic and perioperative parameters. Systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, estimated blood loss, amount of fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be documented. The relationship between PVI/PI measurements and intraoperative hemodynamic changes, bleeding, fluid administration and transfusion requirements will be analyzed.
- Conditions
- Craniosynostosis
- Keywords
- Pleth Variability Index, Perfusion Index, Craniosynostosis Surgery, Pediatric Anesthesia, Hemodynamic Monitoring, Intraoperative Hemodynamics, Fluid Management
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Craniosynostosis Surgery Cohort | Pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. Pleth variability index (PVI), perfusion index (PI), standard hemodynamic variables, fluid administration, blood loss, transfusion requirements, urine output, blood gas parameters and intraoperative complications will be recorded during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters
The primary outcome is the association between intraoperative pleth variability index (PVI) values and hemodynamic parameters, including systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate and central venous pressure, in pediatric patients undergoing craniosynostosis surgery.
Measured: From induction of anesthesia until the end of surgery
Secondary outcomes (5)
Association Between Perfusion Index and Intraoperative Hemodynamic Parameters
The association between intraoperative perfusion index (PI) values and systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, central venous pressure and oxygen saturation will be evaluated.
Measured: From induction of anesthesia until the end of surgery
Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement
The relationship between PVI/PI measurements and estimated blood loss, intraoperative fluid replacement and blood product transfusion requirement will be analyzed.
Measured: From skin incision until the end of surgery
Association of PVI and PI With Intraoperative Fluid Replacement
The relationship between PVI/PI values and the amount of intraoperative crystalloid, colloid and blood product administration will be evaluated.
Measured: From induction of anesthesia until the end of surgery
Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters
The association between PVI/PI measurements and serum lactate level, blood gas pH, base excess, central venous oxygen saturation, urine output and body temperature will be assessed.
Measured: From induction of anesthesia until the end of surgery
Intraoperative Hemodynamic Complications
The incidence of intraoperative hemodynamic complications, including hypotension and clinically significant hemodynamic instability requiring intervention, will be recorded.
Measured: From induction of anesthesia until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CraniosynostosisStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muzaffer GENCER
- Sponsor type
- Other government
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor-investigator, Muzaffer GENCER, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657598
- Sponsor's protocol ID
- PVI-CRANIO-SD
- Acronym
- PVI-CRANIO
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the pediatric study population, the small sample size and the potential risk of participant re-identification despite de-identification. Aggregate study results may be shared in scientific publications or presentations.
Publications
Moradi Farsani D, Mazaheri Z, Shafa A. The Effect of Tranexamic Acid and Controlled Hypotension on Perioperative Blood Loss in Craniosynostosis Surgery. Anesth Pain Med. 2023 Jan 16;13(1):e130462. doi: 10.5812/aapm-130462. eCollection 2023 Feb.
PubMed 37489171Kearney RA, Rosales JK, Howes WJ. Craniosynostosis: an assessment of blood loss and transfusion practices. Can J Anaesth. 1989 Jul;36(4):473-7. doi: 10.1007/BF03005352.
PubMed 2758548Demirci OL, Cikrikci Isik G, Corbacioglu SK, Cevik Y. Comparing Pleth variability index (PVI) variation induced by passive leg raising and Trendelenburg position in healthy volunteers. Am J Emerg Med. 2020 Feb;38(2):278-281. doi: 10.1016/j.ajem.2019.05.015. Epub 2019 May 7. No abstract available.
PubMed 31109779Nayak P, Singha SK, Khetrapal M, Sharma A. A Randomised Controlled Study Comparing Pulse Pressure Variation (PPV) and Pleth Variability Index (PVI) for Goal-Directed Fluid Therapy Intraoperatively in Patients Undergoing Intracranial (Supratentorial ICSOLs) Surgeries. Rom J Anaesth Intensive Care. 2023 Apr 20;30(1):18-25. doi: 10.2478/rjaic-2023-0003. eCollection 2023 Apr.
PubMed 37547491Broch O, Bein B, Gruenewald M, Hocker J, Schottler J, Meybohm P, Steinfath M, Renner J. Accuracy of the pleth variability index to predict fluid responsiveness depends on the perfusion index. Acta Anaesthesiol Scand. 2011 Jul;55(6):686-93. doi: 10.1111/j.1399-6576.2011.02435.x. Epub 2011 Apr 11.
PubMed 21480831Hughes C, Thomas K, Johnson D, Das S. Anesthesia for surgery related to craniosynostosis: a review. Part 2. Paediatr Anaesth. 2013 Jan;23(1):22-7. doi: 10.1111/j.1460-9592.2012.03922.x. Epub 2012 Aug 7.
PubMed 22882624Renner J, Broch O, Gruenewald M, Scheewe J, Francksen H, Jung O, Steinfath M, Bein B. Non-invasive prediction of fluid responsiveness in infants using pleth variability index. Anaesthesia. 2011 Jul;66(7):582-9. doi: 10.1111/j.1365-2044.2011.06715.x. Epub 2011 May 3.
PubMed 21539529
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Pleth Variability Index Monitoring With Intraoperative Hemodynamic Control in Pediatric Craniosynostosis Surgery
- ClinicalTrials.gov ID
- NCT07657598
- Acronym / sponsor ID
- PVI-CRANIO / PVI-CRANIO-SD
- Conditions
- Craniosynostosis
- Keywords
- Pleth Variability Index, Perfusion Index, Craniosynostosis Surgery, Pediatric Anesthesia, Hemodynamic Monitoring, Intraoperative Hemodynamics, Fluid Management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Muzaffer GENCEROther government
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 18 Jun 2026 (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 prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis surgery. Patients aged 0-6 years will be monitored intraoperatively using standard anesthesia monitoring together with PVI and PI measurements. Hemodynamic parameters, including systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, blood loss, fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be recorded. The study will assess the association between PVI/PI changes and intraoperative hemodynamic status, bleeding and transfusion requirements.
Detailed description
Craniosynostosis surgery in pediatric patients is associated with a high risk of intraoperative blood loss and hemodynamic instability. Because children have a relatively low circulating blood volume, early detection of intravascular volume changes is essential for maintaining adequate perfusion and preventing hypotension. Goal-directed fluid management may improve oxygen delivery and overall hemodynamic stability during major surgical procedures.
Pleth variability index (PVI) is a noninvasive dynamic parameter derived from pulse oximetry waveform analysis and reflects respiratory variations in the perfusion index (PI). PI and PVI may provide useful information regarding peripheral perfusion, volume status and fluid responsiveness during mechanical ventilation. However, data regarding the utility of these parameters in pediatric craniosynostosis surgery are limited.
In this prospective observational study, pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. PVI and PI values will be recorded at predefined time points during surgery together with standard hemodynamic and perioperative parameters. Systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, estimated blood loss, amount of fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be documented. The relationship between PVI/PI measurements and intraoperative hemodynamic changes, bleeding, fluid administration and transfusion requirements will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Craniosynostosis Surgery Cohort | – | –Pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. Pleth variability index (PVI), perfusion index (PI), standard hemodynamic variables, fluid administration, blood loss, transfusion requirements, urine output, blood gas parameters and intraoperative complications will be recorded during surgery. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients aged 0-6 years who are scheduled to undergo craniosynostosis surgery at Başakşehir Çam and Sakura City Hospital will constitute the study population.
Key inclusion criteria (4 listed)
- Pediatric patients aged 0 to 6 years
- Patients scheduled to undergo craniosynostosis surgery
- American Society of Anesthesiologists physical status I, II or III
- Written informed consent obtained from the parent or legal guardian
Key exclusion criteria (7 listed)
- Patients older than 6 years
- American Society of Anesthesiologists physical status IV
- Inappropriate preoperative fasting status
- History of significant cardiac, pulmonary or renal disease
- Patients operated at another institution and subsequently transferred to the study center
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
Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters
Time frame: From induction of anesthesia until the end of surgery
The primary outcome is the association between intraoperative pleth variability index (PVI) values and hemodynamic parameters, including systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate and central venous pressure, in pediatric patients undergoing craniosynostosis surgery.
5 secondary outcomes
Association Between Perfusion Index and Intraoperative Hemodynamic Parameters
Time frame: From induction of anesthesia until the end of surgery
Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement
Time frame: From skin incision until the end of surgery
Association of PVI and PI With Intraoperative Fluid Replacement
Time frame: From induction of anesthesia until the end of surgery
Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters
Time frame: From induction of anesthesia until the end of surgery
Intraoperative Hemodynamic Complications
Time frame: From induction of anesthesia until the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 37489171Moradi Farsani D, Mazaheri Z, Shafa A. The Effect of Tranexamic Acid and Controlled Hypotension on Perioperative Blood Loss in Craniosynostosis Surgery. Anesth Pain Med. 2023 Jan 16;13(1):e130462. doi: 10.5812/aapm-130462. eCollection 2023 Feb.
- Background: PubMed 2758548Kearney RA, Rosales JK, Howes WJ. Craniosynostosis: an assessment of blood loss and transfusion practices. Can J Anaesth. 1989 Jul;36(4):473-7. doi: 10.1007/BF03005352.
- Background: PubMed 31109779Demirci OL, Cikrikci Isik G, Corbacioglu SK, Cevik Y. Comparing Pleth variability index (PVI) variation induced by passive leg raising and Trendelenburg position in healthy volunteers. Am J Emerg Med. 2020 Feb;38(2):278-281. doi: 10.1016/j.ajem.2019.05.015. Epub 2019 May 7. No abstract available.
- Background: PubMed 37547491Nayak P, Singha SK, Khetrapal M, Sharma A. A Randomised Controlled Study Comparing Pulse Pressure Variation (PPV) and Pleth Variability Index (PVI) for Goal-Directed Fluid Therapy Intraoperatively in Patients Undergoing Intracranial (Supratentorial ICSOLs) Surgeries. Rom J Anaesth Intensive Care. 2023 Apr 20;30(1):18-25. doi: 10.2478/rjaic-2023-0003. eCollection 2023 Apr.
- Background: PubMed 21480831Broch O, Bein B, Gruenewald M, Hocker J, Schottler J, Meybohm P, Steinfath M, Renner J. Accuracy of the pleth variability index to predict fluid responsiveness depends on the perfusion index. Acta Anaesthesiol Scand. 2011 Jul;55(6):686-93. doi: 10.1111/j.1399-6576.2011.02435.x. Epub 2011 Apr 11.
- Background: PubMed 22882624Hughes C, Thomas K, Johnson D, Das S. Anesthesia for surgery related to craniosynostosis: a review. Part 2. Paediatr Anaesth. 2013 Jan;23(1):22-7. doi: 10.1111/j.1460-9592.2012.03922.x. Epub 2012 Aug 7.
- Background: PubMed 21539529Renner J, Broch O, Gruenewald M, Scheewe J, Francksen H, Jung O, Steinfath M, Bein B. Non-invasive prediction of fluid responsiveness in infants using pleth variability index. Anaesthesia. 2011 Jul;66(7):582-9. doi: 10.1111/j.1365-2044.2011.06715.x. Epub 2011 May 3.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the pediatric study population, the small sample size and the potential risk of participant re-identification despite de-identification. Aggregate study results may be shared in scientific publications or presentations.
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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.
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 Craniosynostosis, run by Muzaffer GENCER at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muzaffer Gencer, associate professor (+90 212 909 60 00, dr.m.gencer07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters (time frame: From induction of anesthesia until the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657598, which also lists 7 linked publications.
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 18 Jun 2026.