Clinical trial NCT03963089: Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
Official title: Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Volume
Tidal Volume
Keywords: Fluid Therapy
Hemodynamic Monitoring
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 30
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Stroke volume index
timeFrame: From sternal closure to 5 minutes after fluid loading
measure: Predictability_PPV and SPV
timeFrame: From sternal closure to 5 minutes after fluid loading
Secondary outcomes:
measure: Predictability_△Vpeak
timeFrame: From sternal closure to 5 minutes after fluid loading
measure: Grey zone
timeFrame: From sternal closure to 5 minutes after fluid loading
Other outcomes:
measure: Heart rate
timeFrame: From start of anesthesia to end of anesthesia
measure: Pulse oximetry
timeFrame: From start of anesthesia to end of anesthesia
measure: End-tidal carbon dioxide
timeFrame: From start of anesthesia to end of anesthesia
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.