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

Primary Purpose

Supratentorial Neoplasms, Anesthesia, General, Optic Nerve

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PEEP variations
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Supratentorial Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical TheatersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supratentorial tumor surgery

Arm Description

Patients undergoing elective supratentorial tumor surgery under general anesthesia will be ventilated with positive end-expiratory pressures of 0, 5 and 10 cmH2O after craniotomy.

Outcomes

Primary Outcome Measures

Subdural pressure
22G/ 0.9mm catheter will be introduced into subdural space after craniotomy and connected to the transducer for pressure measurement
Optic nerve sheath diameter (left and right)
Ultrasound-guided measurement with the linear probe.

Secondary Outcome Measures

Mean arterial pressure
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
Brain relaxation index
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
Arterial blood gases
Arterial oxygen pressure and arterial carbon dioxide pressure will be recorded
Regional cerebral oxygen saturation
% - measurement taken with INVOS cerebral oximeter
Lung compliance
L/cmH2O - measurement taken from Draeger Dräger Perseus® A500 mechanical ventilator

Full Information

First Posted
March 18, 2020
Last Updated
March 19, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04316208
Brief Title
Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Neoplasms, Anesthesia, General, Optic Nerve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
After craniotomy, PEEP will be adjusted to 0 cmH2O, 5 cmH2O and 10 cmH2O for 5 minutes each to collect the data
Masking
None (Open Label)
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
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supratentorial tumor surgery
Arm Type
Experimental
Arm Description
Patients undergoing elective supratentorial tumor surgery under general anesthesia will be ventilated with positive end-expiratory pressures of 0, 5 and 10 cmH2O after craniotomy.
Intervention Type
Procedure
Intervention Name(s)
PEEP variations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subdural pressure
Description
22G/ 0.9mm catheter will be introduced into subdural space after craniotomy and connected to the transducer for pressure measurement
Time Frame
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)
Title
Optic nerve sheath diameter (left and right)
Description
Ultrasound-guided measurement with the linear probe.
Time Frame
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)
Secondary Outcome Measure Information:
Title
Mean arterial pressure
Description
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
Time Frame
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)
Title
Brain relaxation index
Description
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
Time Frame
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)
Title
Arterial blood gases
Description
Arterial oxygen pressure and arterial carbon dioxide pressure will be recorded
Time Frame
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)
Title
Regional cerebral oxygen saturation
Description
% - measurement taken with INVOS cerebral oximeter
Time Frame
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)
Title
Lung compliance
Description
L/cmH2O - measurement taken from Draeger Dräger Perseus® A500 mechanical ventilator
Time Frame
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)
Other Pre-specified Outcome Measures:
Title
P/F ratio
Description
Obtained by PaO2/FiO2. Hence FiO2 will be recorded at the times of measurements
Time Frame
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)
Title
Brain perfusion pressure
Description
Calculated from subdural pressure and mean arterial pressure
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem Korkmaz Dilmen, MD
Phone
+90 212 414 34 35
Email
korkmazdilmen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eren F Akcil, MD
Phone
+90 212 414 34 35
Email
erenfat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusuf Tunali, MD
Organizational Affiliation
Istanbul University Cerrahpasa Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozlem K Korkmaz Dilmen, MD
Phone
+90 212 414 34 35
Email
korkmazdilmen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15761353
Citation
Caricato A, Conti G, Della Corte F, Mancino A, Santilli F, Sandroni C, Proietti R, Antonelli M. Effects of PEEP on the intracranial system of patients with head injury and subarachnoid hemorrhage: the role of respiratory system compliance. J Trauma. 2005 Mar;58(3):571-6. doi: 10.1097/01.ta.0000152806.19198.db.
Results Reference
background
PubMed Identifier
15668765
Citation
Mascia L, Grasso S, Fiore T, Bruno F, Berardino M, Ducati A. Cerebro-pulmonary interactions during the application of low levels of positive end-expiratory pressure. Intensive Care Med. 2005 Mar;31(3):373-9. doi: 10.1007/s00134-004-2491-2. Epub 2005 Jan 25.
Results Reference
background
PubMed Identifier
28342045
Citation
Flexman AM, Gooderham PA, Griesdale DE, Argue R, Toyota B. Effects of an alveolar recruitment maneuver on subdural pressure, brain swelling, and mean arterial pressure in patients undergoing supratentorial tumour resection: a randomized crossover study. Can J Anaesth. 2017 Jun;64(6):626-633. doi: 10.1007/s12630-017-0863-7. Epub 2017 Mar 24.
Results Reference
background
PubMed Identifier
30221312
Citation
Corradi F, Robba C, Tavazzi G, Via G. Combined lung and brain ultrasonography for an individualized "brain-protective ventilation strategy" in neurocritical care patients with challenging ventilation needs. Crit Ultrasound J. 2018 Sep 17;10(1):24. doi: 10.1186/s13089-018-0105-4.
Results Reference
background
PubMed Identifier
15481716
Citation
Rasmussen M, Bundgaard H, Cold GE. Craniotomy for supratentorial brain tumors: risk factors for brain swelling after opening the dura mater. J Neurosurg. 2004 Oct;101(4):621-6. doi: 10.3171/jns.2004.101.4.0621.
Results Reference
background
PubMed Identifier
28671879
Citation
Ruggieri F, Beretta L, Corno L, Testa V, Martino EA, Gemma M. Feasibility of Protective Ventilation During Elective Supratentorial Neurosurgery: A Randomized, Crossover, Clinical Trial. J Neurosurg Anesthesiol. 2018 Jul;30(3):246-250. doi: 10.1097/ANA.0000000000000442.
Results Reference
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Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure

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