Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients

Surgery Clinical Trial

Official title:

The Accuracy of the Noninvasive Hemoglobin Monitoring for Preoperative Evaluation for Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02484365
• Other study ID #: C2014202(1399)
• Status: Recruiting
• Start date: December 2014
• Est. completion date: March 2019

Study information

• Verified date: July 2018
• Source: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Contact: Yong-Hee Park
• Phone: 82
• Email: dada822[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The preoperative evaluation including sampling blood in pediatric patients is hard to perform. However, the knowledge of the baseline cell blood count is important to prepare unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small children is often failed and sometimes induces iatrogenic blood loss and parent's complaints. The Pulse Co-oximetry (Masimo) is recently developed device which can provide noninvasive hemoglobin value. However, the accuracy is controversial. There are studies in pediatric patients during surgery and in ICU. However, the comparison for preoperative evaluation is not analysed. Therefore, the investigators want to evaluate the accuracy for preoperative preparation in pediatric patients.

Description:

There are not enough data comparing the noninvasive hemoglobin and venous hemoglobin in pediatric patients during preoperative period. The investigators will collect the venous sample and the noninvasive hemoglobin data from masimo within 1 hour. Without any additional medication, the patients will visit preanesthetic room and attach the probe of masimo on index finger. The R 20L or R25L will be used based on their weight. The parameter will be stabilized within 2 minutes and the SpHb and perfusion index will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• ASA class 1,2

Exclusion Criteria:

• Poor peripheral circulation

• Infection or trauma on the sensor contact region

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• No treatment
Attach adhesive probe on thumb or index finger

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Jung YH, Lee J, Kim HS, Shin SH, Sohn JA, Kim EK, Choi JH. The efficacy of noninvasive hemoglobin measurement by pulse CO-oximetry in neonates. Pediatr Crit Care Med. 2013 Jan;14(1):70-3. doi: 10.1097/PCC.0b013e318260117d. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin	no F/U is needed	once, preoperative visit anesthetic office