NCT03963089

Brief Summary

This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

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 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

May 19, 2019

Last Update Submit

May 4, 2022

Conditions

Plasma VolumeTidal Volume

Keywords

Fluid TherapyHemodynamic Monitoring

Outcome Measures

Primary Outcomes (2)

  • Stroke volume index

    Define subject that shows increase of stroke volume index more than 15% after 10mL/kg of fluid loading as fluid responder, otherwise as non-responder

    From sternal closure to 5 minutes after fluid loading

  • Predictability_PPV and SPV

    Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of pulse pressure variation and systolic pressure variation after each change of set tidal volume

    From sternal closure to 5 minutes after fluid loading

Secondary Outcomes (2)

  • Predictability_△Vpeak

    From sternal closure to 5 minutes after fluid loading

  • Grey zone

    From sternal closure to 5 minutes after fluid loading

Other Outcomes (3)

  • Heart rate

    From start of anesthesia to end of anesthesia

  • Pulse oximetry

    From start of anesthesia to end of anesthesia

  • End-tidal carbon dioxide

    From start of anesthesia to end of anesthesia

Study Arms (1)

Study group

EXPERIMENTAL

Measure pulse pressure variation and systolic pressure variation after each set of tidal volume to 6mL/kg, 10mL/kg and 14mL/kg. Measure respiratory variation of aortic blood flow peak velocity via transesophageal echocardiography at tidal volume of 10mL/kg. Measure stroke volume index via transesophageal echocardiography before and 5 min after fluid loading with 10mL/kg of crystalloid.

Procedure: Tidal volume_6mL/kgProcedure: Tidal volume_10mL/kgProcedure: Tidal volume_14mL/kgProcedure: Fluid loading

Interventions

Tidal volume_6mL/kgPROCEDURE

Set tidal volume to 6mL/kg for 1 minute

Study group
Tidal volume_10mL/kgPROCEDURE

Set tidal volume to 10mL/kg for 1 minute

Study group
Tidal volume_14mL/kgPROCEDURE

Set tidal volume to 10mL/kg for 1 minute

Study group
Fluid loadingPROCEDURE

Administer 10mL/kg of crystalloid for 5 minutes

Study group

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children younger than 6 years old planned to undergo ventricular septal defect closure or atrial septal defect closure under general anesthesia

You may not qualify if:

  • Children with other complex cardiac defects
  • Children with arrhythmia
  • Children with preoperatively measured ejection fraction of less than 30%
  • Children with underlying pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (5)

  • Gan H, Cannesson M, Chandler JR, Ansermino JM. Predicting fluid responsiveness in children: a systematic review. Anesth Analg. 2013 Dec;117(6):1380-92. doi: 10.1213/ANE.0b013e3182a9557e.

    PMID: 24257389BACKGROUND

  • Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.

    PMID: 18259726BACKGROUND

  • Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.

    PMID: 23250892BACKGROUND

  • Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.

    PMID: 21705869BACKGROUND

  • Min JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074.

    PMID: 28974059BACKGROUND

Study Officials

  • Jin-Tae Kim, M.D, Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2019

First Posted

May 24, 2019

Study Start

May 30, 2019

Primary Completion

June 23, 2020

Study Completion

October 6, 2020

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)