Extracorporeal Life SupportNCT05930691
Optic Nerve Sheath Diameter and the Duration of Extracorporeal Life Support During Newborn Cardiac Surgery
An observational study of Extracorporeal Life Support, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Extracorporeal Life Support
- What is being tested?
- Optic nerve sheath diameter measurement
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- ASA III or IV status newborn;
- Have surgery for transposition of great arteries (TGA).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Association Between the Optic Nerve Sheath Diameter and Extracorporeal Life Support Time During Cardiac Surgery in Newborn
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.
Read the 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.
- Conditions
- Extracorporeal Life Support
- Being tested
- Optic nerve sheath diameter measurement
- Keywords
- Pediatric Cardiovascular surgery, Optic Nerve Sheath diameter, intracranial pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath diameter measurementDiagnostic test
Prediction of intracranial pressure by using Ultrasonography on optic nerve sheath diameter.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Our secondary outcome will be ONSD in aortic cross-clamp time.
Measured: 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
Our secondary outcome will be ONSD in operation time.
Measured: 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.
Our secondary outcome will be ONSD variation for the ECLS period.
Measured: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start15 May 2023
- Primary completion13 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Life SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydın Mermer, Konya City Hospital
- Investigators
- Aydın Mermer, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930691
- Sponsor's protocol ID
- 2023/4253
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between the Optic Nerve Sheath Diameter and Extracorporeal Life Support Time During Cardiac Surgery in Newborn
- ClinicalTrials.gov ID
- NCT05930691
- Acronym / sponsor ID
- 2023/4253
- Conditions
- Extracorporeal Life Support
- Keywords
- Pediatric Cardiovascular surgery, Optic Nerve Sheath diameter, intracranial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- ASA III or IV status newborn;
- Have surgery for transposition of great arteries (TGA).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve sheath diameter measurementPrediction of intracranial pressure by using Ultrasonography on optic nerve sheath diameter. | Diagnostic test | – |
Primary outcome
Correlation between optic nerve sheath diameter and extra corperal support life time.
Time frame: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
The Primary outcome of this study will be identifing ONSD in ECLS time in newborns.
3 secondary outcomes
Staticticaly meaningful between Cross clamp time and optic nerve sheath diameter
Time frame: 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
Time frame: 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.
Time frame: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aydın Mermer, MD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Life Support, run by Konya City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between optic nerve sheath diameter and extra corperal support life time. (time frame: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.