SurgeryNCT02484365
Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients
An observational study of Surgery, run by Chung-Ang University Hospital at 1 site in South Korea.
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.. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Surgery
- What is being tested?
- No treatment
- How many people
- 177 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients age under 18 years planning to receive elective surgery under general anesthesia people live in South Korea
Who may be able to join
- ASA class 1,2
Who cannot join
- Poor peripheral circulation
- Infection or trauma on the sensor contact region
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
Seoul
Yong-Hee Park, 82, dada822@naver.com
About this study
Official title: The Accuracy of the Noninvasive Hemoglobin Monitoring for Preoperative Evaluation for Pediatric Patients
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- No treatment
- Keywords
- Hemoglobins, Monitoring, Outpatient, Preoperative Period, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatmentOther
Attach adhesive probe on thumb or index finger
| Study group | Role | What they receive |
|---|---|---|
| single arm study | No treatment or intervention will given to the patients Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin
no F/U is needed
Measured: once, preoperative visit anesthetic office
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-Hee Park, Chung-Ang University Hospital
- Investigators
- Yong-Hee Park, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484365
- Sponsor's protocol ID
- C2014202(1399)
- Status last verified
- Jul 2018
- First submitted
- 6 Mar 2015
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23132397
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of the Noninvasive Hemoglobin Monitoring for Preoperative Evaluation for Pediatric Patients
- ClinicalTrials.gov ID
- NCT02484365
- Acronym / sponsor ID
- C2014202(1399)
- Conditions
- Surgery
- Keywords
- Hemoglobins, Monitoring, Outpatient, Preoperative Period, Pediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | – | Other: No treatmentNo treatment or intervention will given to the patients |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients age under 18 years planning to receive elective surgery under general anesthesia people live in South Korea
Key inclusion criteria (1 listed)
- ASA class 1,2
Key exclusion criteria (2 listed)
- Poor peripheral circulation
- Infection or trauma on the sensor contact region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatmentAttach adhesive probe on thumb or index finger | Other | single arm study |
Primary outcome
hemoglobin
Time frame: once, preoperative visit anesthetic office
no F/U is needed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Results publication: PubMed 23132397Jung 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-Hee Park principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Chung-Ang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-Hee Park (82, dada822@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin (time frame: once, preoperative visit anesthetic office). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.