Regional Cerebral Oxygen SaturationNCT05961917
Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation
A study testing 5 cmH2O Positive end-expiratory pressure (PEEP) and 10 cmH2O Positive end-expiratory pressure (PEEP) in people with Regional Cerebral Oxygen Saturation, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective single-blind randomized clinical trial is to compare the effect of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen saturation in patients scheduled for craniotomy due to supratentorial masses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Cerebral Oxygen Saturation
- What is being tested?
- 5 cmH2O Positive end-expiratory pressure (PEEP) and 10 cmH2O Positive end-expiratory pressure (PEEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 15 Nov 2023
- 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
- Older than 18 years
- American Society of Anesthesiologists physical status classification system (ASA) I and II
- Patients scheduled for elective craniotomy
- Patients with supratentorial mass
Who cannot join
- Hemoglobin concentration lower than 9 mg/dL
- Uncontrolled hypertension
- Congestive heart failure
- Severe chronic obstructive lung disease
- Cerebrovascular disease
- Pulmonary edema
Show all 11Show fewer
- History of carotis surgery or stenosis of carotid artery
- Unstable hemodynamics
- Pregnancy
- Skin reaction to the NIRS sensor
- Patient's refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences İzmir Bozyaka Education and Research Hospital
Izmir, Bozyaka
About this study
Official title: Evaluation of the Effect of Different PEEP Levels on Regional Cerebral Oxygen Saturation in Patients Undergoing Elective Craniotomy for Excision of Brain Tumors ; Randomized Controlled Clinical Trial
The goal of this prospective single-blind randomized clinical trial is to compare the effect of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen saturation in patients scheduled for craniotomy due to supratentorial masses.
The main question it aims to answer is that how high PEEP level effects the regional cerebral oxygen saturation in patients with high intracranial pressure due to mass effect. Patients will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O). Researchers will compare the changes of regional cerebral oxygen saturations between two groups by near infra-red spectroscopy.
Read the detailed description
In this prospective single-blind study, American Society of Anesthesiologists physical status classification system (ASA) I and II patients aged older than 18 years undergoing craniotomy will be enrolled for the study. Patients will be divided into two groups with computer-based randomization technique. Written and verbal approval will be taken from all patients. Premedication will not be used. Patients will be monitorized by standard non-invasive monitorization (electrocardiography, non-invasive blood pressure measurement, peripheral oxygen saturation) in the operating room. Cerebral/somatic oximeter, near infra-red spectroscopy (NIRS) sensor will be placed on the frontotemporal area and regional cerebral oxygen saturation will be monitorized continuously. Remifentanil infusion with a dose of 0.25 mcg/kg/min will be started two minutes before the induction. After preoxygenation with 6 L/min oxygen for 5 minutes, general anesthesia induction for patients in both groups will be held with intravenous 2 mg/kg propofol. Rocuronium bromide (0.6 mg/kg) will be used for muscle relaxation. Endotracheal intubation will be performed. Controlled mechanical ventilation will be used during the surgery. Invasive arterial blood pressure monitorization will be done and a central venous catheter will be placed in both groups.
In group low PEEP, the patients' settings of mechanical ventilation will be as tidal volume 6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 5 cmH2O. Frequency will be set according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.
In group high PEEP, the patients' settings of mechanical ventilation will be as tidal volume 6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 10 cmH2O. Frequency will be set according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.
Remifentanil with a dose of 0.05-2 mcg kg/min and propofol with a dose of 50-200 mcg/kg/min will be infused for general anesthesia maintenance in both groups. Dose of remifentanil infusion will be changed according to the blood pressure. If the mean arterial blood pressure and/or heart rate will decrease to 20% of the baseline mean arterial blood pressure and heart rate, the infusion dose will be lowered. If this decrease in heart rate will be over 25%, intravenous 0.5 mg atropin will be administered. If the mean arterial blood pressure will be under 55 mmHg, intravenous 5 mg ephedrine will be administered. If the mean arterial blood pressure will continue to decrease, PEEP will be lowered. If the peripheral oxygen saturation will be under 92%, the inspired oxygen fraction or PEEP will be increased. In these conditions, the patient will be out of study.
1 gr paracetamol will be given intravenously for pain relief. Sugammadex will be used with a dose of 4 mg/kg for extubation.
Regional cerebral oxygen saturation measures will be recorded nine (9) times during the study; pre-induction (period 1), post-induction (period 2), skull pinning (period 3), before dura opening (period 4), after dura opening (period 5), surgical resection of the mass (period 6), dura closure (period 7), end of the surgery (period 8) and end of anesthesia (period 9).
- Conditions
- Regional Cerebral Oxygen Saturation
- Being tested
- 5 cmH2O Positive end-expiratory pressure (PEEP), 10 cmH2O Positive end-expiratory pressure (PEEP)
- Keywords
- regional cerebral oxygen saturation, PEEP, craniotomy, near-infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 cmH2O Positive end-expiratory pressure (PEEP)Other
PEEP will be set at 5 cmH2O
10 cmH2O Positive end-expiratory pressure (PEEP)Other
PEEP will be set at 10 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Group low PEEP | Active comparator | Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation. Receives: Other: 5 cmH2O Positive end-expiratory pressure (PEEP) |
| Group high PEEP | Active comparator | Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation. Receives: Other: 10 cmH2O Positive end-expiratory pressure (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional cerebral oxygen saturation (SrO2) period 1
The measurement of regional cerebral oxygen saturation before anesthesia induction
Measured: Pre-induction
regional cerebral oxygen saturation (SrO2) period 2
The measurement of regional cerebral oxygen saturation after anesthesia induction
Measured: Up to 5 minutes after anethesia induction
regional cerebral oxygen saturation (SrO2) period 3
The measurement of regional cerebral oxygen saturation during skull pinning
Measured: From skull-pinning to final head position
regional cerebral oxygen saturation (SrO2) period 4
The measurement of regional cerebral oxygen saturation before dura opening
Measured: Just before dura opening
regional cerebral oxygen saturation (SrO2) period 5
The measurement of regional cerebral oxygen saturation after dura opening
Measured: Up to 5 minutes of dura opening
regional cerebral oxygen saturation (SrO2) period 6
The measurement of regional cerebral oxygen saturation during surgical resection of the mass
Measured: During surgical resection
regional cerebral oxygen saturation (SrO2) period 7
The measurement of regional cerebral oxygen saturation after dura closure
Measured: Up to 5 minutes of dura closure
regional cerebral oxygen saturation (SrO2) period 8
The measurement of regional cerebral oxygen saturation at the end of surgery
Measured: Within 5 minutes after the surgery
regional cerebral oxygen saturation (SrO2) period 9
The measurement of regional cerebral oxygen saturation at the end of anesthesia
Measured: Within 5 minutes after end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Feb 2023
- Primary completion15 Oct 2023
- Study completion15 Nov 2023
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 Regional Cerebral Oxygen SaturationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halide Hande Şahinkaya, Bozyaka Training and Research Hospital
- Investigators
- Halide H Şahinkaya, MD, Study chair, University of Health Sciences İzmir Bozyaka Education and Research HospitalÇağlar Ayar, MD, Study chair, University of Health Sciences İzmir Bozyaka Education and Research HospitalAlper Tabanlı, MD, Study chair, University of Health Sciences İzmir Bozyaka Education and Research HospitalZeki T Tekgül, MD, Study chair, University of Health Sciences İzmir Bozyaka Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961917
- Sponsor's protocol ID
- NIRS
- Status last verified
- Aug 2024
- First submitted
- 30 Jun 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kemerci PU, Demir A, Aydinli B, Guclu CY, Karadeniz U, Cicek OF, Tasoglu I, Ozgok A. 10 cm H2O PEEP application in laparoscopic surgery and cerebral oxygenation: a comparative study with INVOS and FORESIGHT. Surg Endosc. 2016 Mar;30(3):971-8. doi: 10.1007/s00464-015-4277-8. Epub 2015 Jun 23.
PubMed 26099617Chen H, Zhou XF, Zhou DW, Zhou JX, Yu RG. Effect of increased positive end-expiratory pressure on intracranial pressure and cerebral oxygenation: impact of respiratory mechanics and hypovolemia. BMC Neurosci. 2021 Nov 25;22(1):72. doi: 10.1186/s12868-021-00674-9.
PubMed 34823465Calderon-Arnulphi M, Alaraj A, Slavin KV. Near infrared technology in neuroscience: past, present and future. Neurol Res. 2009 Jul;31(6):605-14. doi: 10.1179/174313209X383286.
PubMed 19660190
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different PEEP Levels on Regional Cerebral Oxygen Saturation in Patients Undergoing Elective Craniotomy for Excision of Brain Tumors ; Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05961917
- Acronym / sponsor ID
- NIRS
- Conditions
- Regional Cerebral Oxygen Saturation
- Keywords
- regional cerebral oxygen saturation, PEEP, craniotomy, near-infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 27 Jul 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.
The goal of this prospective single-blind randomized clinical trial is to compare the effect of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen saturation in patients scheduled for craniotomy due to supratentorial masses.
The main question it aims to answer is that how high PEEP level effects the regional cerebral oxygen saturation in patients with high intracranial pressure due to mass effect. Patients will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O). Researchers will compare the changes of regional cerebral oxygen saturations between two groups by near infra-red spectroscopy.
Detailed description
In this prospective single-blind study, American Society of Anesthesiologists physical status classification system (ASA) I and II patients aged older than 18 years undergoing craniotomy will be enrolled for the study. Patients will be divided into two groups with computer-based randomization technique. Written and verbal approval will be taken from all patients. Premedication will not be used. Patients will be monitorized by standard non-invasive monitorization (electrocardiography, non-invasive blood pressure measurement, peripheral oxygen saturation) in the operating room. Cerebral/somatic oximeter, near infra-red spectroscopy (NIRS) sensor will be placed on the frontotemporal area and regional cerebral oxygen saturation will be monitorized continuously. Remifentanil infusion with a dose of 0.25 mcg/kg/min will be started two minutes before the induction. After preoxygenation with 6 L/min oxygen for 5 minutes, general anesthesia induction for patients in both groups will be held with intravenous 2 mg/kg propofol. Rocuronium bromide (0.6 mg/kg) will be used for muscle relaxation. Endotracheal intubation will be performed. Controlled mechanical ventilation will be used during the surgery. Invasive arterial blood pressure monitorization will be done and a central venous catheter will be placed in both groups.
In group low PEEP, the patients' settings of mechanical ventilation will be as tidal volume 6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 5 cmH2O. Frequency will be set according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.
In group high PEEP, the patients' settings of mechanical ventilation will be as tidal volume 6-8 mL/kg, inspired oxygen fraction (FiO2) 0.4, PEEP 10 cmH2O. Frequency will be set according to the end tidal carbon dioxide pressure (ETCO2) where it will be 30-32 mmHg.
Remifentanil with a dose of 0.05-2 mcg kg/min and propofol with a dose of 50-200 mcg/kg/min will be infused for general anesthesia maintenance in both groups. Dose of remifentanil infusion will be changed according to the blood pressure. If the mean arterial blood pressure and/or heart rate will decrease to 20% of the baseline mean arterial blood pressure and heart rate, the infusion dose will be lowered. If this decrease in heart rate will be over 25%, intravenous 0.5 mg atropin will be administered. If the mean arterial blood pressure will be under 55 mmHg, intravenous 5 mg ephedrine will be administered. If the mean arterial blood pressure will continue to decrease, PEEP will be lowered. If the peripheral oxygen saturation will be under 92%, the inspired oxygen fraction or PEEP will be increased. In these conditions, the patient will be out of study.
1 gr paracetamol will be given intravenously for pain relief. Sugammadex will be used with a dose of 4 mg/kg for extubation.
Regional cerebral oxygen saturation measures will be recorded nine (9) times during the study; pre-induction (period 1), post-induction (period 2), skull pinning (period 3), before dura opening (period 4), after dura opening (period 5), surgical resection of the mass (period 6), dura closure (period 7), end of the surgery (period 8) and end of anesthesia (period 9).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group low PEEP | Active comparator | Other: 5 cmH2O Positive end-expiratory pressure (PEEP)Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation. |
| Group high PEEP | Active comparator | Other: 10 cmH2O Positive end-expiratory pressure (PEEP)Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years
- American Society of Anesthesiologists physical status classification system (ASA) I and II
- Patients scheduled for elective craniotomy
- Patients with supratentorial mass
Key exclusion criteria (11 listed)
- Hemoglobin concentration lower than 9 mg/dL
- Uncontrolled hypertension
- Congestive heart failure
- Severe chronic obstructive lung disease
- Cerebrovascular disease
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 |
|---|---|---|
| 5 cmH2O Positive end-expiratory pressure (PEEP)PEEP will be set at 5 cmH2O | Other | Group low PEEP |
| 10 cmH2O Positive end-expiratory pressure (PEEP)PEEP will be set at 10 cmH2O | Other | Group high PEEP |
Primary outcome
regional cerebral oxygen saturation (SrO2) period 1
Time frame: Pre-induction
The measurement of regional cerebral oxygen saturation before anesthesia induction
regional cerebral oxygen saturation (SrO2) period 2
Time frame: Up to 5 minutes after anethesia induction
The measurement of regional cerebral oxygen saturation after anesthesia induction
regional cerebral oxygen saturation (SrO2) period 3
Time frame: From skull-pinning to final head position
The measurement of regional cerebral oxygen saturation during skull pinning
regional cerebral oxygen saturation (SrO2) period 4
Time frame: Just before dura opening
The measurement of regional cerebral oxygen saturation before dura opening
regional cerebral oxygen saturation (SrO2) period 5
Time frame: Up to 5 minutes of dura opening
The measurement of regional cerebral oxygen saturation after dura opening
regional cerebral oxygen saturation (SrO2) period 6
Time frame: During surgical resection
The measurement of regional cerebral oxygen saturation during surgical resection of the mass
regional cerebral oxygen saturation (SrO2) period 7
Time frame: Up to 5 minutes of dura closure
The measurement of regional cerebral oxygen saturation after dura closure
regional cerebral oxygen saturation (SrO2) period 8
Time frame: Within 5 minutes after the surgery
The measurement of regional cerebral oxygen saturation at the end of surgery
regional cerebral oxygen saturation (SrO2) period 9
Time frame: Within 5 minutes after end of anesthesia
The measurement of regional cerebral oxygen saturation at the end of anesthesia
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 13 Aug 2024.
- Background: PubMed 26099617Kemerci PU, Demir A, Aydinli B, Guclu CY, Karadeniz U, Cicek OF, Tasoglu I, Ozgok A. 10 cm H2O PEEP application in laparoscopic surgery and cerebral oxygenation: a comparative study with INVOS and FORESIGHT. Surg Endosc. 2016 Mar;30(3):971-8. doi: 10.1007/s00464-015-4277-8. Epub 2015 Jun 23.
- Background: PubMed 34823465Chen H, Zhou XF, Zhou DW, Zhou JX, Yu RG. Effect of increased positive end-expiratory pressure on intracranial pressure and cerebral oxygenation: impact of respiratory mechanics and hypovolemia. BMC Neurosci. 2021 Nov 25;22(1):72. doi: 10.1186/s12868-021-00674-9.
- Background: PubMed 19660190Calderon-Arnulphi M, Alaraj A, Slavin KV. Near infrared technology in neuroscience: past, present and future. Neurol Res. 2009 Jul;31(6):605-14. doi: 10.1179/174313209X383286.
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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.
Halide H Şahinkaya, MD study chair
University of Health Sciences İzmir Bozyaka Education and Research Hospital
Çağlar Ayar, MD study chair
University of Health Sciences İzmir Bozyaka Education and Research Hospital
Alper Tabanlı, MD study chair
University of Health Sciences İzmir Bozyaka Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 cmH2O Positive end-expiratory pressure (PEEP) and 10 cmH2O Positive end-expiratory pressure (PEEP) in people with Regional Cerebral Oxygen Saturation, run by Bozyaka Training 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 4 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 13 Aug 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?
regional cerebral oxygen saturation (SrO2) period 1 (time frame: Pre-induction). The study lists 9 primary outcomes in all. 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 NCT05961917, 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 13 Aug 2024.