Optic Nerve Sheath Diameter and the Duration of Extracorporeal Life Support During Newborn Cardiac Surgery

Extracorporeal Life Support Clinical Trial

Official title:

Evaluation of the Association Between the Optic Nerve Sheath Diameter and Extracorporeal Life Support Time During Cardiac Surgery in Newborn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05930691
• Other study ID #: 2023/4253
• Status: Completed
• Start date: May 15, 2023
• Est. completion date: June 21, 2023

Study information

• Verified date: July 2023
• Source: Konya City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 21, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

Inclusion Criteria:

• ASA III or IV status newborn;

• Have surgery for transposition of great arteries (TGA).

Exclusion Criteria:

• All off-pump cardiac surgery;

• Recent history of cerebrovascular accident or intracranial hypertension due to any cause;

• History of increased ICP;

• Ophthalmological diseases capable of affecting optic nerve diameters.

Related Conditions & MeSH terms

• Extracorporeal Life Support

Intervention

Diagnostic Test:
• Optic nerve sheath diameter measurement
Prediction of intracranial pressure by using Ultrasonography on optic nerve sheath diameter.

Locations

Country	Name	City	State
Turkey	Konya City Hospital	Konya	Karatay

Sponsors (1)

Lead Sponsor	Collaborator
Konya City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between optic nerve sheath diameter and extra corperal support life time.	The Primary outcome of this study will be identifing ONSD in ECLS time in newborns.	Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Secondary	Staticticaly meaningful between Cross clamp time and optic nerve sheath diameter	Our secondary outcome will be ONSD in aortic cross-clamp time.	Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Secondary	Staticticaly meaningful between operation time and optic nerve sheath diameter	Our secondary outcome will be ONSD in operation time.	Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Secondary	Perioperative ONSD variation for the ECLS period.	Our secondary outcome will be ONSD variation for the ECLS period.	Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.