Perfusion IndexNCT06967675
Perfusion Index in Pediatric Low-Flow Anesthesia
A study testing Low-Flow Anesthesia (LFA) in people with Perfusion Index and Low-Flow Anesthesia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate changes in perfusion index (PI) in pediatric patients undergoing elective surgery under low-flow anesthesia. PI will be monitored at multiple intraoperative and postoperative time points to assess its relationship with hemodynamic stability and depth of anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Perfusion Index, Low-Flow Anesthesia, Postoperative Recovery
- What is being tested?
- Low-Flow Anesthesia (LFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 10 Aug 2025
- Phase
- Interventional
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II pediatric patients
- Age 2 to 12 years
- Undergoing elective surgery lasting between 1-6 hours
- Informed consent obtained from parents/guardians
Who cannot join
- Cardiovascular, respiratory, neurological, metabolic, or endocrine disorders
- Premature birth with corrected age < 2 years
- Obesity or severe malnutrition (BMI <5th or >95th percentile)
- Psychiatric or neurodevelopmental disorders (e.g., autism)
- Malignant hyperthermia or hypersensitivity to anesthetics
- Emergency surgeries
Show all 13Show fewer
- Lack of IV access requiring inhalational induction
- Contraindications to low-flow anesthesia including:
- Severe pulmonary disease
- Congenital heart disease with shunt physiology
- Anticipated high oxygen demand
- Airway obstruction risk
- Surgeries requiring high gas flow or >6 hours duration
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
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
ilke dolgun, ilkeser2004@gmail.com
ilke dolgun
About this study
Official title: Changes in Perfusion Index Under Low-Flow Anesthesia and Its Effects on Postoperative Emergence in Pediatric Patients
This study aims to evaluate changes in perfusion index (PI) in pediatric patients undergoing elective surgery under low-flow anesthesia. PI will be monitored at multiple intraoperative and postoperative time points to assess its relationship with hemodynamic stability and depth of anesthesia. The study will also investigate whether low-flow anesthesia affects the incidence of emergence agitation (EA). Patients will be assigned to either low-flow or normal-flow anesthesia groups based on routine clinical practice. No intervention will be applied beyond standard care. The findings are expected to provide insight into the predictive value of PI in postoperative recovery and support safer anesthesia practices in pediatric populations.
- Conditions
- Perfusion Index, Low-Flow Anesthesia, Postoperative Recovery
- Being tested
- Low-Flow Anesthesia (LFA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Flow Anesthesia (LFA)Procedure or surgery
General anesthesia with a fresh gas flow rate of 1 L/min (50% oxygen + 50% air).
| Study group | Role | What they receive |
|---|---|---|
| Low-Flow Anesthesia Group (LFA) | Experimental | Patients will receive general anesthesia using a fresh gas flow rate of 1 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at predetermined time points. Receives: Procedure: Low-Flow Anesthesia (LFA) |
| Normal-Flow Anesthesia Group (HFA) | Active comparator | Patients will receive general anesthesia using a fresh gas flow rate of 2 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at the same time points. Receives: Procedure: Low-Flow Anesthesia (LFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perfusion Index (PI)
Perfusion Index (PI) will be measured at 11 predefined perioperative time points to assess its intraoperative variation and its potential correlation with anesthesia depth and emergence profile in pediatric patients undergoing low-flow vs normal-flow anesthesia.
Measured: From induction to 30 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 Jun 2025
- Primary completion5 Aug 2025 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perfusion IndexStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ediatric patients undergoing elective surgery will be followed in two naturally assigned groups based on anesthesia flow rate: low-flow (LFA) and normal-flow (HFA). No intervention will be applied outside routine clinical care, and all data will be collected through perioperative monitoring.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967675
- Sponsor's protocol ID
- haseki low flow
- Status last verified
- Jul 2025
- First submitted
- 3 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krishnamohan A, Siriwardana V, Skowno JJ. Using a pulse oximeter to determine clinical depth of anesthesia-investigation of the utility of the perfusion index. Paediatr Anaesth. 2016 Nov;26(11):1106-1111. doi: 10.1111/pan.13000. Epub 2016 Aug 28.
PubMed 27569026RYALINO, CHRISTOPHER, et al. Low-flow anesthesia technique reduces emergence agitation in pediatric patients underwent general anesthesia. Asian Journal of Pharmaceutical and Clinical Research, 2019, 12.5: 139-41.
Kowalczyk M, Fijalkowska A, Nestorowicz A. New generation pulse oximetry in the assessment of peripheral perfusion during general anaesthesia - a comparison between propofol and desflurane. Anaesthesiol Intensive Ther. 2013 Jul-Sep;45(3):138-44. doi: 10.5603/AIT.2013.0029.
PubMed 24092509
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Perfusion Index Under Low-Flow Anesthesia and Its Effects on Postoperative Emergence in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06967675
- Acronym / sponsor ID
- haseki low flow
- Conditions
- Perfusion Index, Low-Flow Anesthesia, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 5 Aug 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 13 May 2025 (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 study aims to evaluate changes in perfusion index (PI) in pediatric patients undergoing elective surgery under low-flow anesthesia. PI will be monitored at multiple intraoperative and postoperative time points to assess its relationship with hemodynamic stability and depth of anesthesia. The study will also investigate whether low-flow anesthesia affects the incidence of emergence agitation (EA). Patients will be assigned to either low-flow or normal-flow anesthesia groups based on routine clinical practice. No intervention will be applied beyond standard care. The findings are expected to provide insight into the predictive value of PI in postoperative recovery and support safer anesthesia practices in pediatric populations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- ediatric patients undergoing elective surgery will be followed in two naturally assigned groups based on anesthesia flow rate: low-flow (LFA) and normal-flow (HFA). No intervention will be applied outside routine clinical care, and all data will be collected through perioperative monitoring.
| Arm | Type | Receives |
|---|---|---|
| Low-Flow Anesthesia Group (LFA) | Experimental | Procedure: Low-Flow Anesthesia (LFA)Patients will receive general anesthesia using a fresh gas flow rate of 1 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at predetermined time points. |
| Normal-Flow Anesthesia Group (HFA) | Active comparator | Procedure: Low-Flow Anesthesia (LFA)Patients will receive general anesthesia using a fresh gas flow rate of 2 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at the same time points. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA I-II pediatric patients
- Age 2 to 12 years
- Undergoing elective surgery lasting between 1-6 hours
- Informed consent obtained from parents/guardians
Key exclusion criteria (13 listed)
- Cardiovascular, respiratory, neurological, metabolic, or endocrine disorders
- Premature birth with corrected age < 2 years
- Obesity or severe malnutrition (BMI <5th or >95th percentile)
- Psychiatric or neurodevelopmental disorders (e.g., autism)
- Malignant hyperthermia or hypersensitivity to anesthetics
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 |
|---|---|---|
| Low-Flow Anesthesia (LFA)General anesthesia with a fresh gas flow rate of 1 L/min (50% oxygen + 50% air). | Procedure or surgery | Low-Flow Anesthesia Group (LFA), Normal-Flow Anesthesia Group (HFA) |
Primary outcome
Change in Perfusion Index (PI)
Time frame: From induction to 30 minutes after extubation
Perfusion Index (PI) will be measured at 11 predefined perioperative time points to assess its intraoperative variation and its potential correlation with anesthesia depth and emergence profile in pediatric patients undergoing low-flow vs normal-flow anesthesia.
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 10 Jul 2025.
- Results publication: PubMed 27569026Krishnamohan A, Siriwardana V, Skowno JJ. Using a pulse oximeter to determine clinical depth of anesthesia-investigation of the utility of the perfusion index. Paediatr Anaesth. 2016 Nov;26(11):1106-1111. doi: 10.1111/pan.13000. Epub 2016 Aug 28.
- Results publicationRYALINO, CHRISTOPHER, et al. Low-flow anesthesia technique reduces emergence agitation in pediatric patients underwent general anesthesia. Asian Journal of Pharmaceutical and Clinical Research, 2019, 12.5: 139-41.
- Results publication: PubMed 24092509Kowalczyk M, Fijalkowska A, Nestorowicz A. New generation pulse oximetry in the assessment of peripheral perfusion during general anaesthesia - a comparison between propofol and desflurane. Anaesthesiol Intensive Ther. 2013 Jul-Sep;45(3):138-44. doi: 10.5603/AIT.2013.0029.
- Individual participant dataSharing planned: No
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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?
A study testing Low-Flow Anesthesia (LFA) in people with Perfusion Index and Low-Flow Anesthesia, run by Istinye University 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 13 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 10 Jul 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 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 ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perfusion Index (PI) (time frame: From induction to 30 minutes after extubation). 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 NCT06967675, which also lists 3 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 10 Jul 2025.