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

NCT05930691 | Completed

• 1 other identifier: 2023/4253
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extracorporeal Life Support

Keywords

Pediatric Cardiovascular surgery; Optic Nerve Sheath diameter; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Staticticaly meaningful between Cross clamp time and optic nerve sheath diameter

  Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.

• Staticticaly meaningful between operation time and optic nerve sheath diameter

  Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.

• Perioperative ONSD variation for the ECLS period.

  Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.

Interventions

Optic nerve sheath diameter measurement DIAGNOSTIC_TEST

Prediction of intracranial pressure by using Ultrasonography on optic nerve sheath diameter.

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• ASA III or IV status newborn;
• Have surgery for transposition of great arteries (TGA).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

Location

Study Officials

• Aydın Mermer, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director, Head of Anesthesiology, Principal Investigator, Clinical Speicialist

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 5, 2023
• Study Start: May 15, 2023
• Primary Completion: June 13, 2023
• Study Completion: June 21, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

TU (1)