Tidal Volume Clinical Trial
Official title:
Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
Verified date | May 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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
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 |
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