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出境医 / 临床实验 / Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children

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

Study Description
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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : March 31, 2021
Arms and Interventions
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
Outcome Measures
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)


Eligibility Criteria
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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
Contacts and Locations

Contacts
Layout table for location contacts
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

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Sang-Hwan Ji, M.D., M.S.    +82-2-2072-3661    taepoongshin@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jin-Tae Kim, M.D, Ph.D. Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE May 19, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE May 30, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 22, 2019)
  • Heart rate [ Time Frame: From start of anesthesia to end of anesthesia ]
    Heart rate determined by electrocardiogram (beats/min)
  • Pulse oximetry [ Time Frame: From start of anesthesia to end of anesthesia ]
    Pulse oximetry determined by photoplethysmography (%)
  • End-tidal carbon dioxide [ Time Frame: From start of anesthesia to end of anesthesia ]
    End-tidal carbon dioxide measured from ventilatory circuit (mmHg)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
Official Title  ICMJE Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Plasma Volume
  • Tidal Volume
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Procedure: Tidal volume_6mL/kg
  • Procedure: Tidal volume_10mL/kg
  • Procedure: Tidal volume_14mL/kg
  • Procedure: Fluid loading
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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963089
Other Study ID Numbers  ICMJE 1902-119-1013
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jin-Tae Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin-Tae Kim, M.D, Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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