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

Anesthesia, General Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316208
• Other study ID #: ST_18032020
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2020
• Source: Istanbul University
• Contact: Özlem Korkmaz Dilmen, MD
• Phone: +90 212 414 34 35
• Email: korkmazdilmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Optic Nerve
• Supratentorial Neoplasms

Intervention

Procedure:
• PEEP 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.

Locations

Country	Name	City	State
Turkey	Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View 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. — View 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. Epub 2005 Jan 25. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	P/F ratio	Obtained by PaO2/FiO2. Hence FiO2 will be recorded at the times of measurements	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	Brain perfusion pressure	Calculated from subdural pressure and 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)
Primary	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)
Primary	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	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	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	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	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	Arterial blood gases	Arterial oxygen pressure and arterial carbon dioxide pressure will be recorded	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	Regional cerebral oxygen saturation	% - measurement taken with INVOS cerebral oximeter	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	Lung compliance	L/cmH2O - measurement taken from Draeger Dräger Perseus® A500 mechanical ventilator	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)