Ventilation ModeNCT06407362
Effects of Volume and Pressure-Controlled Ventilation on Cerebral SpO2, PI, and PVI Index in Septoplasty
An observational study of Ventilation Mode and Pleth Variability Index, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study was designed to evaluate the accuracy of Pleth Variability Index (PVI), Perfusion Index (PI) and Regional Oxygen Saturation (rSO2) in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation Mode, Pleth Variability Index, Perfusion Index
- What is being tested?
- Cerebral Oxygen Saturation
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 15 Jan 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were undergoing septoplasty surgery
Who may be able to join
- patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were included
Who cannot join
- Those patients with any Liver and/or Kidney Failure
- obese patients (Body Mass Index (BMI) 30 and above)
- trauma patients
- cancer patients
- ASA IV patients
- those patients with emergency surgery
Show all 9Show fewer
- cardiac arrhythmia
- implanted pacemakers
- those with a history of chronic pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
Sanliurfa, 63050
About this study
Official title: Evaluation of the Effects of Volume-Controlled and Pressure-Controlled Ventilation on Cerebral Oxygen Saturation, Perfusion Index, and Pleth Variability Index in Septoplasty Surgical Cases: an Observational Prospective Study
Objective: This study was designed to evaluate the accuracy of Pleth Variability Index (PVI), Perfusion Index (PI) and Regional Oxygen Saturation (rSO2) in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia. Materials and Methods: After anaesthesia induction, ventilation was provided with volume control for 20 minutes. Heart Rate (HR), PI, PVI, Oxygen Saturation (SpO2), Non-Invasive Blood Pressure (NIBP) and rSO2 values were recorded every 5 minutes. At the 20th minute of the surgical procedure, the ventilation mode was set as the pressure-controlled mode. After switching to pressure-controlled mode, HR, PI, PVI, SpO2, NIBP and rSO2 values were recorded every 5 minutes for 20 minutes.
- Conditions
- Ventilation Mode, Pleth Variability Index, Perfusion Index, Regional Cerebral Oxygen Saturation
- Being tested
- Cerebral Oxygen Saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Oxygen SaturationDiagnostic test
Also called Pleth Variability Index, Perfusion Index
We have designed this study to evaluate the accuracy of PVI, PI and rSO2 in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Patients who had undergone septoplasty | Not described Receives: Diagnostic Test: Cerebral Oxygen Saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleth Variability Index (PVI) in patients under different ventilation modes
The objective of this study was to demonstrate the percentage difference in the Pleth Variability Index (PVI) between the two ventilation modes in patients undergoing septorhinoplasty.
Measured: while the surgery procedure
Perfusion Index (PI) in patients under different ventilation modes
The objective of this study was to demonstrate the percentage difference in the Perfusion Index (PI) between the two ventilation modes in patients undergoing septorhinoplasty.
Measured: while the surgery procedure
Regional Cerebral Oxygen Saturation (rSO2) in patients under different ventilation modes
The objective of this study was to demonstrate the percentage difference in the Regional Cerebral Oxygen Saturation (rSO2) between the two ventilation modes in patients undergoing septorhinoplasty.
Measured: while the surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 May 2021
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation ModeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmet kaya, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407362
- Sponsor's protocol ID
- MAIEAH630001
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 9 May 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Volume-Controlled and Pressure-Controlled Ventilation on Cerebral Oxygen Saturation, Perfusion Index, and Pleth Variability Index in Septoplasty Surgical Cases: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT06407362
- Acronym / sponsor ID
- MAIEAH630001
- Conditions
- Ventilation Mode, Pleth Variability Index, Perfusion Index, Regional Cerebral Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 9 May 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.
Objective: This study was designed to evaluate the accuracy of Pleth Variability Index (PVI), Perfusion Index (PI) and Regional Oxygen Saturation (rSO2) in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia. Materials and Methods: After anaesthesia induction, ventilation was provided with volume control for 20 minutes. Heart Rate (HR), PI, PVI, Oxygen Saturation (SpO2), Non-Invasive Blood Pressure (NIBP) and rSO2 values were recorded every 5 minutes. At the 20th minute of the surgical procedure, the ventilation mode was set as the pressure-controlled mode. After switching to pressure-controlled mode, HR, PI, PVI, SpO2, NIBP and rSO2 values were recorded every 5 minutes for 20 minutes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who had undergone septoplasty | – | Diagnostic Test: Cerebral Oxygen Saturation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were undergoing septoplasty surgery
Key inclusion criteria (1 listed)
- patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were included
Key exclusion criteria (9 listed)
- Those patients with any Liver and/or Kidney Failure
- obese patients (Body Mass Index (BMI) 30 and above)
- trauma patients
- cancer patients
- ASA IV patients
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 |
|---|---|---|
| Cerebral Oxygen SaturationAlso: Pleth Variability Index, Perfusion IndexWe have designed this study to evaluate the accuracy of PVI, PI and rSO2 in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia | Diagnostic test | Patients who had undergone septoplasty |
Primary outcome
Pleth Variability Index (PVI) in patients under different ventilation modes
Time frame: while the surgery procedure
The objective of this study was to demonstrate the percentage difference in the Pleth Variability Index (PVI) between the two ventilation modes in patients undergoing septorhinoplasty.
Perfusion Index (PI) in patients under different ventilation modes
Time frame: while the surgery procedure
The objective of this study was to demonstrate the percentage difference in the Perfusion Index (PI) between the two ventilation modes in patients undergoing septorhinoplasty.
Regional Cerebral Oxygen Saturation (rSO2) in patients under different ventilation modes
Time frame: while the surgery procedure
The objective of this study was to demonstrate the percentage difference in the Regional Cerebral Oxygen Saturation (rSO2) between the two ventilation modes in patients undergoing septorhinoplasty.
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 9 May 2024.
- Individual participant dataSharing planned: Undecided
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Persistent Pulmonary Hypertension, Mechanical Ventilation Strategies
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Effect of Spontaneous Breathing in APRV Mode on Respiratory Physiology of ARDS Patients
Acute Respiratory Distress Syndrome
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Mode of Ventilation During Critical Illness at Multiple Centers
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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 Ventilation Mode and Pleth Variability Index, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital 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 1 inclusion and 9 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 9 May 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 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?
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?
Pleth Variability Index (PVI) in patients under different ventilation modes (time frame: while the surgery procedure). The study lists 3 primary outcomes in all. 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 9 May 2024.