Optic Nerve Sheath Diameter and the Duration of Extracorporeal Life Support During Newborn Cardiac Surgery
Condition: Extracorporeal Life Support
Study type: Observational

Summary: 
      Mortality rates for newborns with congenital heart disease (CHD) have dramatically decreased
      thanks to surgical methods and medical treatment improvements. Up to 70% of patients may have
      post- Extracorporeal life support (ECLS) cerebral dysfunction, which can result in long-term
      cognitive and motor impairment, first showing as brain edema and higher intracranial pressure
      (ICP). Optic Nerve Sheath Diameter (ONSD) is a non-invasive method of measuring Intracranial
      Pressure (ICP). The Primary Aim of this study is to identify the correlation between ONSD and
      ECLS time in newborns who get ECLS.
    

Detailed description: 
      INTRODUCTION Mortality rates for newborns with congenital heart disease (CHD) have
      dramatically decreased thanks to surgical methods and medical treatment improvements. As a
      result, more emphasis is being put on reducing neonatal cardiac surgery morbidity.

      Extracorporeal life support (ECLS) is increasingly being given to children, particularly for
      cardiac causes, according to the Pediatric Extracorporeal Life Support Organization
      Registry's global report. However, up to 70% of patients may have post-ECLS cerebral
      dysfunction, which can result in long-term cognitive and motor impairment, first showing as
      brain edema and higher intracranial pressure (ICP). In addition, pediatric patients may have
      trouble being diagnosed with acute elevations in IİCP since the signs and symptoms are
      sometimes unclear.

      The gold standard for measuring intracranial pressure (ICP) still involves invasive
      intracranial devices. In addition, ICP monitors have the potential to cause complications,
      including bleeding in 1.1-5.8% of cases, malfunction, in 6.3-40% of cases, or infection in
      0-15% of cases, with a noticeable higher risk of bacterial colonization after five days.

      The optic nerve sheath surrounds the Optic Nerve (ON) and covers the optic subarachnoid
      space, which is connected to the intracranial subarachnoid space area. Changes in
      intracranial pressure are thus straightly transferred to the optic nerve sheath. Therefore,
      Optic Nerve Sheath Diameter (ONSD) is a non-invasive method of measuring Intracranial
      Pressure (ICP).

      Longer ECLS periods and aortic cross-clamp times have been linked to more frequent CT
      detection of cerebral edema, according to prior investigationsAccording to prior
      investigations, long ECLS periods, and aortic cross-clamp times have been linked to more
      frequent CT (computer tomography) detection of cerebral edema. However, there is currently no
      information on the relationship between these time points and the ONSD determined by
      ultrasound.

      The Primary Aim of this study was to identify the correlation between ONSD and ECLS time in
      newborns who get ECLS. Specifically, we tested the primary hypothesis that more ECLS time
      means more ONSD valuable over the perioperative period. Our secondary aim was to investigate
      the relationship between ONSD and aortic cross-clamp time and operation time and also,
      operation time and preoperative and intraoperative perioperative ONSD variation for the ECLS
      period.
    

Intervention name(s): Optic nerve sheath diameter measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Prediction of intracranial pressure by using Ultrasonography on optic nerve sheath diameter.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will occur newborns and will have cardiac surgery because of the
        surgery for transposition of great arteries (TGA). We worked on sample size analyses and
        found that it should be 22 patients at least to reach our actual power.
      
Keywords: Pediatric Cardiovascular surgery; Optic Nerve Sheath diameter; intracranial pressure