- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05961917
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
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Halide H Şahinkaya, MD
- Phone Number: +905058892157
- Email: drhhande@yahoo.com
Study Locations
-
-
Bozyaka
-
İzmir, Bozyaka, Turkey
- Recruiting
- University of Health Sciences İzmir Bozyaka Education and Research Hospital
-
Contact:
- Halide H Şahinkaya, MD
- Phone Number: +905058892157
- Email: drhhande@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group low PEEP
Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation.
|
PEEP will be set at 5 cmH2O
|
Active Comparator: Group high PEEP
Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation.
|
PEEP will be set at 10 cmH2O
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
regional cerebral oxygen saturation (SrO2) period 1
Time Frame: Pre-induction
|
The measurement of regional cerebral oxygen saturation before anesthesia induction
|
Pre-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
|
Up to 5 minutes after anethesia 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
|
From skull-pinning to final head position
|
regional cerebral oxygen saturation (SrO2) period 4
Time Frame: Just before dura opening
|
The measurement of regional cerebral oxygen saturation before dura opening
|
Just 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
|
Up to 5 minutes of 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
|
During surgical resection
|
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
|
Up to 5 minutes of 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
|
Within 5 minutes after the 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
|
Within 5 minutes after end of anesthesia
|
Collaborators and Investigators
Investigators
- Study Chair: Halide H Şahinkaya, MD, University of Health Sciences İzmir Bozyaka Education and Research Hospital
- Study Chair: Çağlar Ayar, MD, University of Health Sciences İzmir Bozyaka Education and Research Hospital
- Study Chair: Alper Tabanlı, MD, University of Health Sciences İzmir Bozyaka Education and Research Hospital
- Study Chair: Zeki T Tekgül, MD, University of Health Sciences İzmir Bozyaka Education and Research Hospital
Publications and helpful links
General Publications
- Calderon-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.
- 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.
- Chen 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NIRS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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