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Supratentorial NeoplasmsNCT04316208

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

A study testing PEEP variations in people with Supratentorial Neoplasms and Anesthesia, General, run by Istanbul University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
PEEP variations
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2020to 1 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Özlem Korkmaz Dilmen, MD contact

+90 212 414 34 35

korkmazdilmen@gmail.com

Eren F Akcil, MD contact

+90 212 414 34 35

erenfat@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting

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

    Istanbul, 34098

    Ozlem K Korkmaz Dilmen, MD, +90 212 414 34 35, korkmazdilmen@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
PEEP variations
Medical subject headings
Supratentorial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEEP variationsProcedure or surgery

    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.

Study groups in NCT04316208
Study groupRoleWhat they receive
Supratentorial tumor surgeryExperimentalPatients undergoing elective supratentorial tumor surgery under general anesthesia will be ventilated with positive end-expiratory pressures of 0, 5 and 10 cmH2O after craniotomy.
Receives: Procedure: PEEP variations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subdural pressure

    22G/ 0.9mm catheter will be introduced into subdural space after craniotomy and connected to the transducer for pressure measurement

    Measured: 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.

    Measured: 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 (5)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2020
  2. Study start1 Mar 2020
  3. Primary completion1 Apr 2021 (estimated)
  4. Study completion1 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04316208
Sponsor's protocol ID
ST_18032020
Status last verified
Mar 2020
First submitted
18 Mar 2020
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing PEEP variations in people with Supratentorial Neoplasms and Anesthesia, General, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Özlem Korkmaz Dilmen, MD (+90 212 414 34 35, korkmazdilmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subdural 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04316208, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.

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