Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03963089
Enrollment
30
Registered
2019-05-24
Start date
2019-05-30
Completion date
2020-10-06
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma Volume, Tidal Volume

Keywords

Fluid Therapy, Hemodynamic Monitoring

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.

Interventions

PROCEDURETidal volume_6mL/kg

Set tidal volume to 6mL/kg for 1 minute

PROCEDURETidal volume_10mL/kg

Set tidal volume to 10mL/kg for 1 minute

PROCEDURETidal volume_14mL/kg

Set tidal volume to 10mL/kg for 1 minute

PROCEDUREFluid loading

Administer 10mL/kg of crystalloid for 5 minutes

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stroke volume indexFrom sternal closure to 5 minutes after fluid loadingDefine 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 SPVFrom sternal closure to 5 minutes after fluid loadingArea 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

MeasureTime frameDescription
Predictability_△VpeakFrom sternal closure to 5 minutes after fluid loadingArea 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 zoneFrom sternal closure to 5 minutes after fluid loadingCompare the range that the prediction of fluid responsiveness is unreliable (grey zone) for each variable in each set tidal volume

Other

MeasureTime frameDescription
Pulse oximetryFrom start of anesthesia to end of anesthesiaPulse oximetry determined by photoplethysmography (%)
End-tidal carbon dioxideFrom start of anesthesia to end of anesthesiaEnd-tidal carbon dioxide measured from ventilatory circuit (mmHg)
Heart rateFrom start of anesthesia to end of anesthesiaHeart rate determined by electrocardiogram (beats/min)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026