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Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure

The Effect of Intraoperative Variations in Positive-End Expiratory Pressure on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure in Supratentorial Tumor Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04316208
Enrollment
50
Registered
2020-03-20
Start date
2020-03-01
Completion date
2021-09-01
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General, Optic Nerve, Supratentorial Neoplasms

Brief summary

We aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize optic nerve sheath diameter measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

Detailed description

Application of positive end-expiratory pressure (PEEP) during general anesthesia minimizes ventilation/perfusion mismatch, intraoperative atelectasis and postoperative pulmonary complications. PEEP application in intracranial surgeries is usually avoided due to the risk of raised intracranial pressure (ICP) leading to decreased cerebral perfusion pressure (CPP). Several studies examine the effects of PEEP on subdural pressure and CPP however none examine how lung compliance is affected at the same time. Ultrasound-guided measurement of optic nerve sheath diameter (ONSD) is an indirect indicator of raised ICP and there is limited literature on the correlation of ONSD and ICP during intracranial surgery. In this study, we aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize ONSD measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

Interventions

PROCEDUREPEEP variations

Patients will be ventilated with a PEEP of 5 cmH2O during induction of anesthesia. After craniotomy, the PEEP will be reduced to 0 cmH2O for 5 minutes and data will be collected at the end of 5 minutes. Next, PEEP will be increased to 5 cmH2O for 5 minutes and data will be collected at the end of 5 minutes. Finally, PEEP will be increased to 10 cmH2O for 5 minutes and data will be collected at the end of 5 minutes.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Care provider will adjust the PEEP level, make measurements and record arterial blood gas analysis results. Biostatistician will compare data set at each PEEP to each other. Investigator will analyze the data

Intervention model description

After craniotomy, PEEP will be adjusted to 0 cmH2O, 5 cmH2O and 10 cmH2O for 5 minutes each to collect the data

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Supratentorial tumor * Elective surgery * American Society of Anesthesiologist Class I, II or III

Exclusion criteria

* Midline shift more than 5 mm determined by intracranial imaging * Initial subdural pressure higher than 20 mmHg * Requiring intravenous mannitol or hypertonic saline treatment before dural opening * Congestive heart failure * Pulmonary hypertension * Sepsis * Hypovolemia * Obstructive or restrictive lung disease

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter (left and right)Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)Ultrasound-guided measurement with the linear probe.
Subdural pressureMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)22G/ 0.9mm catheter will be introduced into subdural space after craniotomy and connected to the transducer for pressure measurement

Secondary

MeasureTime frameDescription
Brain relaxation indexMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)1: dura is under the cranium, 2: dura is at the level of the cranium, 3: dura is above the cranium 4: dural pulsations ceased
Regional cerebral oxygen saturationMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)% - measurement taken with INVOS cerebral oximeter
Lung complianceMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)L/cmH2O - measurement taken from Draeger Dräger Perseus® A500 mechanical ventilator
Arterial blood gasesMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)Arterial oxygen pressure and arterial carbon dioxide pressure will be recorded
Mean arterial pressureMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)Invasive blood pressure monitoring will be done. The transducer will be kept at the same level as the transducer for the subdural pressure, at the level of the external ear canal

Other

MeasureTime frameDescription
P/F ratioMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)Obtained by PaO2/FiO2. Hence FiO2 will be recorded at the times of measurements
Brain perfusion pressureMeasurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)Calculated from subdural pressure and mean arterial pressure

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzlem Korkmaz Dilmen, MD
korkmazdilmen@gmail.com+90 212 414 34 35
Backup ContactEren F Akcil, MD
erenfat@yahoo.com+90 212 414 34 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026