Congenital Heart DefectsNCT02417259
Near Infrared Spectroscopy in Cyanotic Congenital Heart Disease
An observational study of Congenital Heart Defects, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
We are conducting a prospective cohort study of 20 children with cyanotic congenital heart disease who are admitted for cardiac surgery. We will record cerebral and somatic near infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien INVOS™ 5100C Cerebral / Somatic Oximeter. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Defects
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2015to Apr 2018
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cyanotic congenital heart disease undergoing cardiac surgery
Who may be able to join
- Pre-operative diagnosis of cyanotic congenital heart disease
- Undergoing any form of cardiac surgery
- Informed consent was given by the caregiver/parent
Who cannot join
- Premature infants <35 weeks corrected age who will be cared for in the neonatal ICU postoperatively
- Congenital lactic acidosis syndromes
Trial locations and contacts
1 site in 1 country.
Singapore1 site
KK Women's and Children's Hospital
Bukit Timah Road, Singapore, 229899
About this study
Official title: Changes in Cerebral and Somatic Near Infrared Spectroscopy Monitoring Before and After Surgery for in Children With Cyanotic Heart Disease
We are conducting a prospective cohort study of 20 children with cyanotic congenital heart disease who are admitted for cardiac surgery. We will record cerebral and somatic near infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively (baseline) and continue until 48hours post-operatively. We will also take measurements prior to discharge from hospital. Baseline demographics, physiological and laboratory variables will be recorded. Clinical outcome variables including mortality, duration of intensive care unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance will also be recorded.
Read the detailed description
NIRS has been used to predict short term clinical outcomes (low cardiac output states, prolonged ventilation, and prolonged hospital stay) and long term clinical outcomes (reduced neurodevelopmental scores at 1year, radiological changes on magnetic resonance imaging). NIRS has also been tested against traditional markers of global tissue perfusion like mixed venous saturation and serum lactate, however, results from these studies are mixed. There is insufficient prospective data evaluating NIRs with direct clinical outcomes and uncertainty about the threshold value or the duration below a threshold value that leads to tissue injury. Because of this lack of data, the benefit and risk of management strategies targeted to improve NIRS values remains unknown.
We will characterize the time series of cerebral and somatic oximetry, pulse oximetry and partial pressure of arterial oxygen in the cyanotic child undergoing surgical repair of a congenital heart defect. We will then determine the correlation between the time series if any. This new information will advance our understanding of the hemodynamic changes that occur in the perioperative period and may lead to new therapeutic targets.
The primary hypothesis is that there is a delayed increase in cerebral and somatic oximetry post-operation as compared pulse oximetry (SpO2) and partial pressure of arterial oxygen (PaO2) which occur immediately.
The secondary hypothesis is to establish the applicability of a desaturation score (decrease of 20% in area under the curve [AUC] over an hour) in the early prediction of adverse outcomes.
The oximetry probes will be placed pre-induction of anesthesia (to determine baseline) and recordings will be continuous throughout the operation and 48hours post-operatively. Children undergoing cardiac surgery generally stay in the hospital for 1-2weeks. We will also take oximetry measurements prior to discharge from hospital (to determine the new steady state). Sites measured are cerebral (forehead) and somatic (left flank).
- Conditions
- Congenital Heart Defects
- Keywords
- Spectroscopy, Near-Infrared
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral oximetry
To show if there is a delayed increase in cerebral oximetry post-operation as compared SpO2 and PaO2 which occur immediately
Measured: 48horus post-operatively
Change in somatic oximetry
To show if there is a delayed increase in somatic oximetry post-operation as compared SpO2 and PaO2 which occur immediately
Measured: 48hours post-operatively
Secondary outcomes (1)
Applicability of a desaturation score in the early detection of adverse outcomes
Cerebral desaturation score (>20% decrease in AUC over an hour) for early detection of adverse outcome such as cardiorespiratory deterioration requiring chest tube insertion, re-do surgery, chest compressions, electrical shock or initiation of extracorporeal membrane oxygenation.
Measured: 48hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Covidien Private Limited
- Responsible party
- Principal investigator, Judith Wong Ju-Ming, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417259
- Sponsor's protocol ID
- 2015/2161
- Status last verified
- Mar 2018
- First submitted
- 10 Apr 2015
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong JJ, Chen CK, Moorakonda RB, Wijeweera O, Tan TYS, Nakao M, Allen JC Jr, Loh TF, Lee JH. Changes in Near-Infrared Spectroscopy After Congenital Cyanotic Heart Surgery. Front Pediatr. 2018 Apr 13;6:97. doi: 10.3389/fped.2018.00097. eCollection 2018.
PubMed 29707528
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral and Somatic Near Infrared Spectroscopy Monitoring Before and After Surgery for in Children With Cyanotic Heart Disease
- ClinicalTrials.gov ID
- NCT02417259
- Acronym / sponsor ID
- 2015/2161
- Conditions
- Congenital Heart Defects
- Keywords
- Spectroscopy, Near-Infrared
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Covidien Private Limited
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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.
We are conducting a prospective cohort study of 20 children with cyanotic congenital heart disease who are admitted for cardiac surgery. We will record cerebral and somatic near infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively (baseline) and continue until 48hours post-operatively. We will also take measurements prior to discharge from hospital. Baseline demographics, physiological and laboratory variables will be recorded. Clinical outcome variables including mortality, duration of intensive care unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance will also be recorded.
Detailed description
NIRS has been used to predict short term clinical outcomes (low cardiac output states, prolonged ventilation, and prolonged hospital stay) and long term clinical outcomes (reduced neurodevelopmental scores at 1year, radiological changes on magnetic resonance imaging). NIRS has also been tested against traditional markers of global tissue perfusion like mixed venous saturation and serum lactate, however, results from these studies are mixed. There is insufficient prospective data evaluating NIRs with direct clinical outcomes and uncertainty about the threshold value or the duration below a threshold value that leads to tissue injury. Because of this lack of data, the benefit and risk of management strategies targeted to improve NIRS values remains unknown.
We will characterize the time series of cerebral and somatic oximetry, pulse oximetry and partial pressure of arterial oxygen in the cyanotic child undergoing surgical repair of a congenital heart defect. We will then determine the correlation between the time series if any. This new information will advance our understanding of the hemodynamic changes that occur in the perioperative period and may lead to new therapeutic targets.
The primary hypothesis is that there is a delayed increase in cerebral and somatic oximetry post-operation as compared pulse oximetry (SpO2) and partial pressure of arterial oxygen (PaO2) which occur immediately.
The secondary hypothesis is to establish the applicability of a desaturation score (decrease of 20% in area under the curve [AUC] over an hour) in the early prediction of adverse outcomes.
The oximetry probes will be placed pre-induction of anesthesia (to determine baseline) and recordings will be continuous throughout the operation and 48hours post-operatively. Children undergoing cardiac surgery generally stay in the hospital for 1-2weeks. We will also take oximetry measurements prior to discharge from hospital (to determine the new steady state). Sites measured are cerebral (forehead) and somatic (left flank).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cyanotic congenital heart disease undergoing cardiac surgery
Key inclusion criteria (3 listed)
- Pre-operative diagnosis of cyanotic congenital heart disease
- Undergoing any form of cardiac surgery
- Informed consent was given by the caregiver/parent
Key exclusion criteria (2 listed)
- Premature infants <35 weeks corrected age who will be cared for in the neonatal ICU postoperatively
- Congenital lactic acidosis syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cerebral oximetry
Time frame: 48horus post-operatively
To show if there is a delayed increase in cerebral oximetry post-operation as compared SpO2 and PaO2 which occur immediately
Change in somatic oximetry
Time frame: 48hours post-operatively
To show if there is a delayed increase in somatic oximetry post-operation as compared SpO2 and PaO2 which occur immediately
1 secondary outcome
Applicability of a desaturation score in the early detection of adverse outcomes
Time frame: 48hours post-operatively
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 3 Apr 2018.
- Derived from this study: PubMed 29707528Wong JJ, Chen CK, Moorakonda RB, Wijeweera O, Tan TYS, Nakao M, Allen JC Jr, Loh TF, Lee JH. Changes in Near-Infrared Spectroscopy After Congenital Cyanotic Heart Surgery. Front Pediatr. 2018 Apr 13;6:97. doi: 10.3389/fped.2018.00097. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Congenital Heart Defects, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 3 inclusion and 2 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 3 Apr 2018. 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 Singapore. 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?
Change in cerebral oximetry (time frame: 48horus post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417259, which also lists 1 linked publication.
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 3 Apr 2018.