CClinicalTrials.gg
CompletedNCT01567371Updated Apr 15, 2016Results posted

LiDCO Monitor Study

An interventional study of LiDCO rapid monitor in Cardiac Surgery, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-04-15.

Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Sex
All
01

Study summary

This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.

02

Conditions studied

  • Cardiac Surgery
03

In context

Lead sponsor

Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    LiDCO rapid monitor

    Device: LiDCO rapid monitor

Interventions

  • DeviceLiDCO rapid monitor

    Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.

06

What researchers measure

Primary outcomes

  1. Difference in Pulse Pressure Variability From Baseline to Post-ANH

    The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

    Time frame: 1 Day

Secondary outcomes

  1. Difference in Stroke Volume Variability From Baseline to Post ANH.

    The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

    Time frame: 1 Day

07

Results

Posted Apr 15, 2016

Participant flow

Participant flow — Overall Study
MilestoneLiDCO Rapid Monitor
Started30
Completed30
Not completed0

Outcome measures

PrimaryDifference in Pulse Pressure Variability From Baseline to Post-ANH

The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

Time frame:
1 Day
Reported as:
Mean · % variability
Difference in Pulse Pressure Variability From Baseline to Post-ANH
% variabilityLiDCO Rapid Monitor
Difference in Pulse Pressure Variability From Baseline to Post-ANH7.46 ± 9.149
SecondaryDifference in Stroke Volume Variability From Baseline to Post ANH.

The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

Time frame:
1 Day
Reported as:
Mean · % variability
Difference in Stroke Volume Variability From Baseline to Post ANH.
% variabilityLiDCO Rapid Monitor
Difference in Stroke Volume Variability From Baseline to Post ANH.4.46 ± 5.368

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LiDCO Rapid Monitor—0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)LiDCO Rapid Monitor
<=18 years16
Between 18 and 65 years14
>=65 years0
Age, Continuous
Age, Continuous(years)LiDCO Rapid Monitor
Mean21.5 ± 11.018
Sex: Female, Male
Sex: Female, Male(Participants)LiDCO Rapid Monitor
Female15
Male15
Region of Enrollment
Region of Enrollment(participants)LiDCO Rapid Monitor
United States30
08

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01567371
Lead sponsor
Nationwide Children's Hospital
Responsible party
Joseph D. Tobias (Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital) — Principal investigator
First posted
Mar 30, 2012
Start date
Mar 2012
Primary completion
Dec 2014
Completion
Mar 2015
Results posted
Apr 15, 2016
Last update
Apr 15, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion