Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02484365
• Collaborator: (none)
• Enrollment: 177
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Other: No treatment

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 177 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Accuracy of the Noninvasive Hemoglobin Monitoring for Preoperative Evaluation for Pediatric Patients
• Study Start Date: Dec 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
single arm study No treatment or intervention will given to the patients	Other: No treatment; Attach adhesive probe on thumb or index finger

Outcome Measures

Primary Outcome Measures

1. hemoglobin [once, preoperative visit anesthetic office]

   no F/U is needed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA class 1,2

Exclusion Criteria:

• Poor peripheral circulation

• Infection or trauma on the sensor contact region

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Investigators

• Principal Investigator: Yong-Hee Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yong-Hee Park, Assistant professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• ClinicalTrials.gov Identifier: NCT02484365
• Other Study ID Numbers: C2014202(1399)
• First Posted: Jun 29, 2015
• Last Update Posted: Jul 18, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Yong-Hee Park, Assistant professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine: Hemoglobins; Monitoring, Outpatient; Preoperative Period; Pediatrics

Study Results

No Results Posted as of Jul 18, 2018