RPVI for Fluid Responsiveness in Children

Anesthesia Clinical Trial

Official title:

Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05601622
• Other study ID #: 2209-123-1363
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: October 20, 2024

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: Sang-Hwan Ji, M.D., Ph.D.
• Phone: +82220723661
• Email: taepoongshin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.

Description:

Children undergoing surgery under general anesthesia will be enrolled. After anesthetic induction, they will be assessed via transthoracic echocardiography for measurement of the patient's stroke volume index (SVI). Also, pleth variability index and Rainbow pleth variability index will be measured under mechanical ventilation with tidal volume of 6, 8, 10 ml/kg.

To exert fluid loading, 10ml/kg of crystalloid solution will be administered intravenously over 10 minutes. After fluid loading, the SVI will be measured again and fluid responsiveness will be determined according to increment ratio of the SVI.

According to the determined fluid responsiveness, predictive power of pleth variability index and Rainbow pleth variability index for fluid responsiveness will be assessed by building a receiver-operating characteristics curve.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• Children undergoing neurosurgery under general anesthesia

Exclusion Criteria:

• Presence of any cardiovascular disease

• Presence of any pulmonary disease

• Decline of enrollment from any of the patient's parents

Related Conditions & MeSH terms

• Anesthesia
• Fluid Responsiveness

Intervention

Procedure:
• Fluid loading
Intravenous administration of 10ml/kg of crystalloids over 10 minutes

Diagnostic Test:
• Transthoracic echocardiography
Transthoracic echocardiographic measurement of stroke volume index
• PVI, RPVI
Continuous measurement of pleth variability index and Rainbow pleth variability index

Procedure:
• Tidal volume change
Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (3)

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

Han YY, Carcillo JA, Dragotta MA, Bills DM, Watson RS, Westerman ME, Orr RA. Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome. Pediatrics. 2003 Oct;112(4):793-9. Review. — View Citation

Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of ROC curve	Area under the curve of the receiver-operating characteristics curve of pleth variability index and Rainbow pleth variability index for prediction of fluid responsiveness	From start of anesthesia to end of anesthesia, Less than 24 hours
Secondary	Appearance of abnormal heart rhythm	Electrocardiogram during the study for monitoring whether tachycardia, bradycardia, or arrhythmia appears. Heart rate will be compared between patients who were fluid responsive and who were not responsive.	From start of anesthesia to end of study, Less than 24 hours
Secondary	IBP	Invasive blood pressure during the study, including systolic, diastolic, mean blood pressure for monitoring whether hypertension or hypotension appears. Mean blood pressure will be compared between patients who were fluid responsive and who were not responsive.	From start of anesthesia to end of study, Less than 24 hours
Secondary	SpO2	Pulse oximetry during the study for monitoring whether hypoxia appears.	From start of anesthesia to end of study, Less than 24 hours