Effect of Different Positive End Expiratory Pressures on Regional Cerebral Oxygen Saturation

NCT05961917 | Completed DMC

• 1 other identifier: NIRS
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective single-blind randomized clinical trial is to compare the effect of two different positive end expiratory pressure (PEEP) levels on regional cerebral oxygen saturation in patients scheduled for craniotomy due to supratentorial masses. The main question it aims to answer is that how high PEEP level effects the regional cerebral oxygen saturation in patients with high intracranial pressure due to mass effect. Patients will be divided into two groups as Group low PEEP (5 cmH2O) and Group high PEEP (10 cmH2O). Researchers will compare the changes of regional cerebral oxygen saturations between two groups by near infra-red spectroscopy.

Conditions

Regional Cerebral Oxygen Saturation

Keywords

regional cerebral oxygen saturation; PEEP; craniotomy; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (9)

• regional cerebral oxygen saturation (SrO2) period 1

  The measurement of regional cerebral oxygen saturation before anesthesia induction

  Pre-induction

• regional cerebral oxygen saturation (SrO2) period 2

  The measurement of regional cerebral oxygen saturation after anesthesia induction

  Up to 5 minutes after anethesia induction

• regional cerebral oxygen saturation (SrO2) period 3

  The measurement of regional cerebral oxygen saturation during skull pinning

  From skull-pinning to final head position

• regional cerebral oxygen saturation (SrO2) period 4

  The measurement of regional cerebral oxygen saturation before dura opening

  Just before dura opening

• regional cerebral oxygen saturation (SrO2) period 5

  The measurement of regional cerebral oxygen saturation after dura opening

  Up to 5 minutes of dura opening

• regional cerebral oxygen saturation (SrO2) period 6

  The measurement of regional cerebral oxygen saturation during surgical resection of the mass

  During surgical resection

• regional cerebral oxygen saturation (SrO2) period 7

  The measurement of regional cerebral oxygen saturation after dura closure

  Up to 5 minutes of dura closure

• regional cerebral oxygen saturation (SrO2) period 8

  The measurement of regional cerebral oxygen saturation at the end of surgery

  Within 5 minutes after the surgery

• regional cerebral oxygen saturation (SrO2) period 9

  The measurement of regional cerebral oxygen saturation at the end of anesthesia

  Within 5 minutes after end of anesthesia

Study Arms (2)

Group low PEEP

ACTIVE COMPARATOR

Positive end-expiratory pressure will be set at 5 cmH2O during controlled mechanical ventilation.

Other: 5 cmH2O Positive end-expiratory pressure (PEEP)

Group high PEEP

ACTIVE COMPARATOR

Positive end-expiratory pressure will be set at 10 cmH2O during controlled mechanical ventilation.

Other: 10 cmH2O Positive end-expiratory pressure (PEEP)

Interventions

5 cmH2O Positive end-expiratory pressure (PEEP) OTHER

PEEP will be set at 5 cmH2O

Group low PEEP

10 cmH2O Positive end-expiratory pressure (PEEP) OTHER

PEEP will be set at 10 cmH2O

Group high PEEP

Eligibility Criteria

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

You may qualify if:

• Older than 18 years
• American Society of Anesthesiologists physical status classification system (ASA) I and II
• Patients scheduled for elective craniotomy
• Patients with supratentorial mass

You may not qualify if:

• Hemoglobin concentration lower than 9 mg/dL
• Uncontrolled hypertension
• Congestive heart failure
• Severe chronic obstructive lung disease
• Cerebrovascular disease
• Pulmonary edema
• History of carotis surgery or stenosis of carotid artery
• Unstable hemodynamics
• Pregnancy
• Skin reaction to the NIRS sensor
• Patient's refusal

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences İzmir Bozyaka Education and Research Hospital

Izmir, Bozyaka, Turkey (Türkiye)

Location

Related Publications (3)

• Kemerci PU, Demir A, Aydinli B, Guclu CY, Karadeniz U, Cicek OF, Tasoglu I, Ozgok A. 10 cm H2O PEEP application in laparoscopic surgery and cerebral oxygenation: a comparative study with INVOS and FORESIGHT. Surg Endosc. 2016 Mar;30(3):971-8. doi: 10.1007/s00464-015-4277-8. Epub 2015 Jun 23.

  PMID: 26099617 BACKGROUND

• Chen H, Zhou XF, Zhou DW, Zhou JX, Yu RG. Effect of increased positive end-expiratory pressure on intracranial pressure and cerebral oxygenation: impact of respiratory mechanics and hypovolemia. BMC Neurosci. 2021 Nov 25;22(1):72. doi: 10.1186/s12868-021-00674-9.

  PMID: 34823465 BACKGROUND

• Calderon-Arnulphi M, Alaraj A, Slavin KV. Near infrared technology in neuroscience: past, present and future. Neurol Res. 2009 Jul;31(6):605-14. doi: 10.1179/174313209X383286.

  PMID: 19660190 BACKGROUND

Study Officials

• Halide H Şahinkaya, MD

  University of Health Sciences İzmir Bozyaka Education and Research Hospital

  STUDY CHAIR

• Çağlar Ayar, MD

  University of Health Sciences İzmir Bozyaka Education and Research Hospital

  STUDY CHAIR

• Alper Tabanlı, MD

  University of Health Sciences İzmir Bozyaka Education and Research Hospital

  STUDY CHAIR

• Zeki T Tekgül, MD

  University of Health Sciences İzmir Bozyaka Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology Specialist, Clinical Director

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 27, 2023
• Study Start: February 15, 2023
• Primary Completion: October 15, 2023
• Study Completion: November 15, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

TU (1)