Gastric CancerNCT03957460
Accuracy of Continuous and Non-invasive Hemoglobin Monitoring
An observational study of Gastric Cancer, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- SpHb monitoring
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2017to 29 Dec 2017
- How long will I take part?
- 1 Day
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were scheduled for laparoscopic gastrectomy and recieved the SpHb monitoring during surgery.
Who may be able to join
- laparoscopic gastrectomy under general anesthesia
Who cannot join
- atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon
About this study
Official title: Accuracy of Continuous and Non-invasive Hemoglobin Monitoring During Laparoscopic Gastrectomy: Observational Study
The primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- SpHb monitoring
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpHb monitoringOther
Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).
| Study group | Role | What they receive |
|---|---|---|
| continuous and noninvasive hemoglobin monitoring | Group receive the continuous and noninvasive hemoglobin monitoring during laparoscopic gastrectomy. Receives: Other: SpHb monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb)
SpHb value in g/dL is measured by co-oxymetry, and SaHb value in g/dL is measured by blood sampling.
Measured: from the start of anesthesia to the end of anesthesia, an average 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start20 Nov 2017
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957460
- Sponsor's protocol ID
- AJIRB-MED-OBS-17-216
- Status last verified
- May 2021
- First submitted
- 17 May 2019
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Continuous and Non-invasive Hemoglobin Monitoring During Laparoscopic Gastrectomy: Observational Study
- ClinicalTrials.gov ID
- NCT03957460
- Acronym / sponsor ID
- AJIRB-MED-OBS-17-216
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 21 May 2019 (actual)
- 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 primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| continuous and noninvasive hemoglobin monitoring | – | Other: SpHb monitoringGroup receive the continuous and noninvasive hemoglobin monitoring during laparoscopic gastrectomy. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were scheduled for laparoscopic gastrectomy and recieved the SpHb monitoring during surgery.
Key inclusion criteria (1 listed)
- laparoscopic gastrectomy under general anesthesia
Key exclusion criteria (1 listed)
- atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
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 |
|---|---|---|
| SpHb monitoringSubjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring). | Other | continuous and noninvasive hemoglobin monitoring |
Primary outcome
difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb)
Time frame: from the start of anesthesia to the end of anesthesia, an average 2 hours
SpHb value in g/dL is measured by co-oxymetry, and SaHb value in g/dL is measured by blood sampling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastric Cancer, run by Ajou University School of Medicine 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 1 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: finished, as of the sponsor's last update on 11 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb) (time frame: from the start of anesthesia to the end of anesthesia, an average 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2021.