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

Tidal Volume Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963089
• Other study ID #: 1902-119-1013
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: October 6, 2020

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 6, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Plasma Volume
• Tidal Volume

Intervention

Procedure:
• Tidal volume_6mL/kg
Set tidal volume to 6mL/kg for 1 minute
• Tidal volume_10mL/kg
Set tidal volume to 10mL/kg for 1 minute
• Tidal volume_14mL/kg
Set tidal volume to 10mL/kg for 1 minute
• Fluid loading
Administer 10mL/kg of crystalloid for 5 minutes

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Heart rate determined by electrocardiogram (beats/min)	From start of anesthesia to end of anesthesia
Other	Pulse oximetry	Pulse oximetry determined by photoplethysmography (%)	From start of anesthesia to end of anesthesia
Other	End-tidal carbon dioxide	End-tidal carbon dioxide measured from ventilatory circuit (mmHg)	From start of anesthesia to end of anesthesia
Primary	Stroke volume index	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	From sternal closure to 5 minutes after fluid loading
Primary	Predictability_PPV and SPV	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	From sternal closure to 5 minutes after fluid loading
Secondary	Predictability_?Vpeak	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	From sternal closure to 5 minutes after fluid loading
Secondary	Grey zone	Compare the range that the prediction of fluid responsiveness is unreliable (grey zone) for each variable in each set tidal volume	From sternal closure to 5 minutes after fluid loading