NCT04895384

Brief Summary

The study aims to develop a novel perioperative noninvasive delivery of oxygen (DO2) and hemodynamic index in the prediction of postoperative outcomes including post-operative acute kidney injury (POAKI), perioperative neurological cognitive disorders (PONCD) and post-operative atrial fibrillation (POAF). Our study also aims to study the effect of DO2 and hemodynamic parameters (measured noninvasively) on the development of PONCD, POAF and POAKI in cardiac surgical patients. We aim to develop a novel DO2 index and hemodynamic index predictive of PONCD, POAF and POAKI. The secondary aim would be to develop real-time machine learning aided algorithms in the analysis of noninvasive continuous hemodynamic and DO2 data, to predict and guide perioperative treatment of POCND, POAF and POAKI in the perioperative setting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 27, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 27, 2023

Status Verified

June 1, 2023

Enrollment Period

3.4 years

First QC Date

May 17, 2021

Last Update Submit

July 24, 2023

Conditions

AKINeurocognitive DisordersAtrial Fibrillation

Keywords

PostoperativePerioperative

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the incidence of primary outcomes of AKI, POAF and PONCD

    Collection of patient's demographics, medical records, surgical records and noninvasive hemodynamic data

    Preoperative through to 90 days postoperatively

Study Arms (1)

Surgical Cohort

Placement of Edwards ClearSight and Masimo SET on patient intraoperatively.

Device: Edwards ClearSight and Masimo SET

Interventions

Edwards ClearSight and Masimo SETDEVICE

Placement of Edwards ClearSight and Masimo SET on the patient intraoperatively.

Surgical Cohort

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective cardiac surgery and age above 21 years old.

You may qualify if:

  • Undergoing elective cardiac surgery such as valve replacements or CABG
  • Age above 21 years old
  • Ability to provide informed consent

You may not qualify if:

  • Emergency cardiac cases
  • Patients on IABP postoperatively
  • Patients who decline to participate in this study
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, Singapore

NOT YET RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

Related Publications (5)

  • Ranucci M, Johnson I, Willcox T, Baker RA, Boer C, Baumann A, Justison GA, de Somer F, Exton P, Agarwal S, Parke R, Newland RF, Haumann RG, Buchwald D, Weitzel N, Venkateswaran R, Ambrogi F, Pistuddi V. Goal-directed perfusion to reduce acute kidney injury: A randomized trial. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1918-1927.e2. doi: 10.1016/j.jtcvs.2018.04.045. Epub 2018 Apr 18.

    PMID: 29778331BACKGROUND

  • Groom RC. Is it Time for Goal-Directed Therapy in Perfusion. J Extra Corpor Technol. 2017 Jun;49(2):P8-P12. No abstract available.

    PMID: 28638164BACKGROUND

  • Raimundo M, Crichton S, Syed Y, Martin JR, Beale R, Treacher D, Ostermann M. Low Systemic Oxygen Delivery and BP and Risk of Progression of Early AKI. Clin J Am Soc Nephrol. 2015 Aug 7;10(8):1340-9. doi: 10.2215/CJN.02780314. Epub 2015 Jul 24.

    PMID: 26209157BACKGROUND

  • Smulter N, Lingehall HC, Gustafson Y, Olofsson B, Engstrom KG, Appelblad M, Svenmarker S. Disturbances in Oxygen Balance During Cardiopulmonary Bypass: A Risk Factor for Postoperative Delirium. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):684-690. doi: 10.1053/j.jvca.2017.08.035. Epub 2017 Aug 25.

    PMID: 29153931BACKGROUND

  • Leenders J, Overdevest E, van Straten B, Golab H. The influence of oxygen delivery during cardiopulmonary bypass on the incidence of delirium in CABG patients; a retrospective study. Perfusion. 2018 Nov;33(8):656-662. doi: 10.1177/0267659118783104. Epub 2018 Jun 29.

    PMID: 29956559BACKGROUND

MeSH Terms

Conditions

Neurocognitive DisordersAtrial Fibrillation

Condition Hierarchy (Ancestors)

Mental DisordersArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ming Ann Sim

    National University Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Ann Sim

CONTACT

6772 4200ming_ann_sim@nuhs.edu.sg

Lian Kah Ti

CONTACT

6772 4200anatilk@nus.edu.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

July 27, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

July 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

SG(2)