Prediction of Fluid Responsiveness in Children Undergoing Major Surgery

Hypovolemia Clinical Trial

Official title:

Prediction of Fluid Responsiveness Using Respiratory Variation in Pulse Oximeter Plethysmography in Children Undergoing Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952651
• Other study ID #: H1609-066-791
• Status: Completed
• Phase: N/A
• First received: October 19, 2016
• Last updated: February 26, 2018
• Start date: May 10, 2017
• Est. completion date: January 20, 2018

Study information

• Verified date: February 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate predictability of a respiratory variation in pulse oximeter plethysmography for fluid responsiveness in children undergoing major surgery.

Description:

The purpose of this study is to evaluate predictability of a a respiratory variation in pulse oximeter plethysmography (delta POP) for fluid responsiveness in children undergoing major surgery.

When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, the study will be started. At index fingers of both hand, pulse oximeter sensors are applied by gradually increasing the contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then, pulse oximeter plethysmography (POP) waveforms are obtained for 90 seconds. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 min.

To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration.

Finally, patients will be divided into fluid responder group and non-responder group. If stroke volume index measured using echocardiography increases over 15% after fluid administration, the patient will be fluid responder.

Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Using receiver operating characteristic curve, diagnostic power of delta POPs from different contact forces for fluid responsiveness will be evaluated. In addition, difference between delta POP from low contact force and that from high contact force will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 20, 2018
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

• Children who will be scheduled for major surgery requiring invasive hemodynamic monitoring

Exclusion Criteria:

• renal, hepatic and pulmonary disease

• preoperative infection: increased C-reactive protein, whith blood cell count over 10,000, and with fever

• genetic and hematologic disease

• ventricular dysfunction

• increased intracranial pressure

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Procedure:
• Pulse oximeter
When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, POP waveforms are obtained from each index finger, which pulse oximeter sensor is applied by increasing contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then intravenous crystalloid 10 mL/kg is infused for 15 min.

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul	Jongro Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability of delta POP for prediction of fluid responsiveness in children	Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Delta POP differs according to contact force. After calculation of each delta POP, we will evaluate the ability to predict fluid responsiveness of delta POP using receiver operating characteristic curve.	Before and after fluid administration (total 20 min)