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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02952651
Other study ID # H1609-066-791
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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