Gastric CancerNCT03430778
Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring
A study testing High end-tidal CO2 and Low CO2 group in people with Gastric Cancer, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the effect of pneumoperitoneum 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?
- High end-tidal CO2 and Low CO2 group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2019to 13 May 2019
- Phase
- Interventional
- 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
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, Seoum
About this study
Official title: Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy: a Randomized Controlled Study
The primary purpose of this study is to investigate the effect of pneumoperitoneum on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy
- Conditions
- Gastric Cancer
- Being tested
- High end-tidal CO2, Low CO2 group
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High end-tidal CO2Other
maintaining of end-tidal CO2 with the range of 40-45 mmHg
Low CO2 groupOther
maintaining of end-tidal CO2 with the range of 30-35 mmHg
| Study group | Role | What they receive |
|---|---|---|
| High CO2 group | Experimental | end tidal CO2 : 40-45 mmHg Receives: Other: High end-tidal CO2 |
| Low CO2 group | Placebo comparator | end tidal CO2 : 30-35 mmHg Receives: Other: Low CO2 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between SpHb value and SaHb value (SpHb - SaHb)
SpHb value is measured by co-oxymetry, and SaHb value 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 posted13 Feb 2018
- Study start1 Jan 2019
- Primary completion13 May 2019
- Study completion13 May 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
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
- NCT03430778
- Sponsor's protocol ID
- AJIRB-MED-OBS-17-339
- Status last verified
- May 2019
- First submitted
- 1 Feb 2018
- Last updated
- 20 May 2019
- 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 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03430778
- Acronym / sponsor ID
- AJIRB-MED-OBS-17-339
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 13 Feb 2018 (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 study is to investigate the effect of pneumoperitoneum on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High CO2 group | Experimental | Other: High end-tidal CO2end tidal CO2 : 40-45 mmHg |
| Low CO2 group | Placebo comparator | Other: Low CO2 groupend tidal CO2 : 30-35 mmHg |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| High end-tidal CO2maintaining of end-tidal CO2 with the range of 40-45 mmHg | Other | High CO2 group |
| Low CO2 groupmaintaining of end-tidal CO2 with the range of 30-35 mmHg | Other | Low CO2 group |
Primary outcome
difference between SpHb value and SaHb value (SpHb - SaHb)
Time frame: from the start of anesthesia to the end of anesthesia, an average 2 hours
SpHb value is measured by co-oxymetry, and SaHb value 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 20 May 2019.
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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?
A study testing High end-tidal CO2 and Low CO2 group in people with 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 20 May 2019. 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. Some participants in this study may receive a placebo. 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 and SaHb value (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 20 May 2019.