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

NCT04316208 | Unknown

• 1 other identifier: ST_18032020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Supratentorial Neoplasms; Anesthesia, General; Optic Nerve

Outcome Measures

Primary Outcomes (2)

• Subdural pressure

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

  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)

• Optic nerve sheath diameter (left and right)

  Ultrasound-guided measurement with the linear probe.

  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)

• Mean arterial pressure

  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)

• Brain relaxation index

  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)

• Arterial blood gases

  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)

• Regional cerebral oxygen saturation

  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)

• Lung compliance

  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 (2)

• P/F ratio

  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)

• Brain perfusion pressure

  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)

Study Arms (1)

Supratentorial tumor surgery

EXPERIMENTAL

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

PEEP variations PROCEDURE

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.

Supratentorial tumor surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 15761353 BACKGROUND

• 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.

  PMID: 15668765 BACKGROUND

• 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.

  PMID: 28342045 BACKGROUND

• 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.

  PMID: 30221312 BACKGROUND

• 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.

  PMID: 15481716 BACKGROUND

• 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.

  PMID: 28671879 BACKGROUND

MeSH Terms

Conditions

Supratentorial Neoplasms

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yusuf Tunali, MD

  Istanbul University Cerrahpasa Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Anesthesiology and Reanimation

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

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: March 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

TU (1)