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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04316208
Other study ID # ST_18032020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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