Clinical trial · Interventional
Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Regional Cerebral Oxygen Saturation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10 cmH2O Positive end-expiratory pressure (PEEP) | Other | — | UNRESOLVED |
| 5 cmH2O Positive end-expiratory pressure (PEEP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group low PEEP
- description
- Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation.
- interventionNames
- Other: 5 cmH2O Positive end-expiratory pressure (PEEP)
- type
- ACTIVE_COMPARATOR
- label
- Group high PEEP
- description
- Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation.
- interventionNames
- Other: 10 cmH2O Positive end-expiratory pressure (PEEP)
Primary outcomes (9)
- measure
- regional cerebral oxygen saturation (SrO2) period 1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Hemoglobin concentration lower than 9 mg/dL * Uncontrolled hypertension * Congestive heart failure * Severe chronic obstructive lung disease * Cerebrovascular disease * Pulmonary edema * History of carotis surgery or stenosis of carotid artery * Unstable hemodynamics * Pregnancy * Skin reaction to the NIRS sensor * Patient's refusal
References
Publications (3)
- BACKGROUNDKemerci 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. PMID 26099617
- BACKGROUNDChen 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. PMID 34823465
- BACKGROUNDCalderon-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. PMID 19660190