Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children

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.

Study Overview

• Status: Completed
• Conditions: Plasma Volume; Tidal Volume
• Intervention / Treatment: Procedure: Tidal volume_6mL/kg; Procedure: Tidal volume_10mL/kg; Procedure: Tidal volume_14mL/kg; Procedure: Fluid loading

Detailed Description

Pressure-based dynamic variables such as pulse pressure variation(PPV) and systolic pressure variation(SPV) are known to be unreliable for prediction of fluid responsiveness in children.

The hypothesis is that tidal volume change in mechanically ventilated children undergoing anesthesia would affect reliability of aforementioned dynamic variables in prediction of fluid responsiveness, especially in the way that reliability increases for high tidal volume.

In children undergoing cardiac surgery, tidal volume is changed to 6mL/kg, 10mL/kg and 14mL/kg after closure of sternum, followed by measurement of PPV, SPV. We also measure the respiratory variation of aortic blood peak velocity(△Vpeak) via transesophageal echocardiography, which is known to best predict fluid responsiveness.

Afterward, 10mL/kg of crystalloid solution is administered for fluid loading. 'Fluid responder' is defined as subjects with increase of stroke volume index more than 15% after fluid loading of 10mL/kg.

With these data, whether the predictability of fluid responsiveness of PPV and SPV changes according to change in tidal volume is evaluated by comparing the area under the curve of the receiver-operating characteristics curve between themselves and △Vpeak.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Study group; 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/kg; Set tidal volume to 6mL/kg for 1 minute; Procedure: Tidal volume_10mL/kg; Set tidal volume to 10mL/kg for 1 minute; Procedure: Tidal volume_14mL/kg; Set tidal volume to 10mL/kg for 1 minute; Procedure: Fluid loading; Administer 10mL/kg of crystalloid for 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictability_△Vpeak	Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of respiratory variation of aortic blood flow peak velocity measured via transesophageal echocardiography at tidal volume of 10mL/kg	From sternal closure to 5 minutes after fluid loading
Grey zone	Compare the range that the prediction of fluid responsiveness is unreliable (grey zone) for each variable in each set tidal volume	From sternal closure to 5 minutes after fluid loading

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate determined by electrocardiogram (beats/min)	From start of anesthesia to end of anesthesia
Pulse oximetry	Pulse oximetry determined by photoplethysmography (%)	From start of anesthesia to end of anesthesia
End-tidal carbon dioxide	End-tidal carbon dioxide measured from ventilatory circuit (mmHg)	From start of anesthesia to end of anesthesia

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin-Tae Kim, M.D, Ph.D., Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2019
• Primary Completion (ACTUAL): June 23, 2020
• Study Completion (ACTUAL): October 6, 2020

Study Registration Dates

• First Submitted: May 19, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (ACTUAL): May 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Fluid Therapy; Hemodynamic Monitoring
• Other Study ID Numbers: 1902-119-1013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No