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NCT Number: NCT03963089

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.

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tidal volume_6mL/kg

Procedure

Set tidal volume to 6mL/kg for 1 minute

Tidal volume_10mL/kg

Procedure

Set tidal volume to 10mL/kg for 1 minute

Tidal volume_14mL/kg

Procedure

Set tidal volume to 10mL/kg for 1 minute

Fluid loading

Procedure

Administer 10mL/kg of crystalloid for 5 minutes

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 24, 2019
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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