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Status unknownNCT04316208Updated Mar 20, 2020

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

An interventional study of PEEP variations in Supratentorial Neoplasms, Anesthesia, General and Optic Nerve, sponsored by Istanbul University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-20.

Sponsored by Istanbul University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Supratentorial Neoplasms
  • Anesthesia, General
  • Optic Nerve
03

In context

Supratentorial Neoplasms

27 studies on the registry are indexed under Supratentorial Neoplasms; 3 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 24 interventional studies indexed under Supratentorial Neoplasms.

Browse Supratentorial Neoplasms studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Supratentorial tumor surgery

    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.

    Procedure: PEEP variations

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.

06

What researchers measure

Primary outcomes

  1. Subdural pressure

    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)

  2. Optic nerve sheath diameter (left and right)

    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 outcomes

  1. 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

    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)

  2. 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

    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)

  3. Arterial blood gases

    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)

  4. Regional cerebral oxygen saturation

    % - 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)

  5. Lung compliance

    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 outcomes

  1. P/F ratio

    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)

  2. Brain perfusion pressure

    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)

07

Study locations

1 of 1 sites recruiting
  • Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters
    Istanbul, 34098, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 15761353 ↗
  • 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. PubMed 15668765 ↗
  • 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. PubMed 28342045 ↗
  • 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. PubMed 30221312 ↗
  • 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. PubMed 15481716 ↗
  • 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. PubMed 28671879 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04316208
Lead sponsor
Istanbul University
Responsible party
Özlem Korkmaz Dilmen (Professor in Anesthesiology and Reanimation, Istanbul University) — Principal investigator
First posted
Mar 20, 2020
Start date
Mar 1, 2020
Primary completion
Apr 1, 2021 (estimated)
Completion
Sep 1, 2021 (estimated)
Last update
Mar 20, 2020

Study contacts

Özlem Korkmaz Dilmen, MD
Contact
korkmazdilmen@gmail.com
+90 212 414 34 35
Eren F Akcil, MD
Contact
erenfat@yahoo.com
+90 212 414 34 35
Yusuf Tunali, MD
principal investigator · Istanbul University Cerrahpasa Medical Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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