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

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ClinicalTrials.gov Identifier: NCT03963089
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Plasma Volume Tidal Volume Procedure: Tidal volume_6mL/kg Procedure: Tidal volume_10mL/kg Procedure: Tidal volume_14mL/kg Procedure: Fluid loading Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

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




Primary Outcome Measures :
  1. Stroke volume index [ Time Frame: From sternal closure to 5 minutes after fluid loading ]
    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

  2. Predictability_PPV and SPV [ Time Frame: From sternal closure to 5 minutes after fluid loading ]
    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


Secondary Outcome Measures :
  1. Predictability_△Vpeak [ Time Frame: From sternal closure to 5 minutes after fluid loading ]
    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

  2. Grey zone [ Time Frame: From sternal closure to 5 minutes after fluid loading ]
    Compare the range that the prediction of fluid responsiveness is unreliable (grey zone) for each variable in each set tidal volume


Other Outcome Measures:
  1. Heart rate [ Time Frame: From start of anesthesia to end of anesthesia ]
    Heart rate determined by electrocardiogram (beats/min)

  2. Pulse oximetry [ Time Frame: From start of anesthesia to end of anesthesia ]
    Pulse oximetry determined by photoplethysmography (%)

  3. End-tidal carbon dioxide [ Time Frame: From start of anesthesia to end of anesthesia ]
    End-tidal carbon dioxide measured from ventilatory circuit (mmHg)



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963089


Contacts
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Contact: Sang-Hwan Ji, M.D. 82-2-2072-3661 taepoongshin@gmail.com
Contact: Young-Eun Jang, M.D. 82-2-2072-3661 na0ag2@hotmail.com

Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, M.D, Ph.D. Seoul National University Hospital

Publications:
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03963089     History of Changes
Other Study ID Numbers: 1902-119-1013
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
Fluid Therapy
Hemodynamic Monitoring