HypoxiaNCT01922401
Inverse Ratio Ventilation on Bariatric Operation
A study testing inverse ratio ventilation in people with Hypoxia, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
for evaluating inverse ratio ventilation of laparoscopic bariatric surgery Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hypoxia
- What is being tested?
- inverse ratio ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2014
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA PS 1-2 obese patients(BMI>30)
Who cannot join
- underlying cardiopulmonary diasease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Changes in Inspiratory to Expiratory Ratio on Respiratory Mechanics and Oxygenation During Laparosopic Bariatric Surgery
for evaluating inverse ratio ventilation of laparoscopic bariatric surgery
Read the detailed description
inverse ratio ventilation had been improve the oxygenation and respiratory mechanics during care of ARDS patients or during general anesthesia. We hypothized inverse ratio ventilatio could improve the oxygenation and respiratory mechanics on the obese patient also.
- Conditions
- Hypoxia
- Being tested
- inverse ratio ventilation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inverse ratio ventilationOther
change the I: E ratio 1:2-1:1-2:1
| Study group | Role | What they receive |
|---|---|---|
| inverse ratio ventilation | Experimental | in one group change the I:E ratio during pneumoperitoneum 1:2-1:2-2:1 Receives: Other: inverse ratio ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygenation (PaO2)
sampling for arterial blood from arterial cannular weill be analysed 10 min after anesthetic induction, 20 min after pneurmoperitoneum (PP)with 1:2 of IE ratio, 20 min after after pneurmoperitoneum (PP)with 1:1 of IE ratio, after pneurmoperitoneum (PP)with 2:1 of IE ratio and end of operation
Measured: baseline PaO2-2hour after pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Yi Jo, Gachon University Gil Medical Center
- Investigators
- Kyung Cheon Lee, M.D, Study director, Gachon Universiy Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922401
- Sponsor's protocol ID
- GCIRB2013-164
- Status last verified
- Aug 2015
- First submitted
- 8 Aug 2013
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Changes in Inspiratory to Expiratory Ratio on Respiratory Mechanics and Oxygenation During Laparosopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01922401
- Acronym / sponsor ID
- GCIRB2013-164
- Conditions
- Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Aug 2013 (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.
for evaluating inverse ratio ventilation of laparoscopic bariatric surgery
Detailed description
inverse ratio ventilation had been improve the oxygenation and respiratory mechanics during care of ARDS patients or during general anesthesia. We hypothized inverse ratio ventilatio could improve the oxygenation and respiratory mechanics on the obese patient also.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inverse ratio ventilation | Experimental | Other: inverse ratio ventilationin one group change the I:E ratio during pneumoperitoneum 1:2-1:2-2:1 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA PS 1-2 obese patients(BMI>30)
Key exclusion criteria (1 listed)
- underlying cardiopulmonary diasease
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 |
|---|---|---|
| inverse ratio ventilationchange the I: E ratio 1:2-1:1-2:1 | Other | inverse ratio ventilation |
Primary outcome
Arterial oxygenation (PaO2)
Time frame: baseline PaO2-2hour after pneumoperitoneum
sampling for arterial blood from arterial cannular weill be analysed 10 min after anesthetic induction, 20 min after pneurmoperitoneum (PP)with 1:2 of IE ratio, 20 min after after pneurmoperitoneum (PP)with 1:1 of IE ratio, after pneurmoperitoneum (PP)with 2:1 of IE ratio and end of operation
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 1 Sep 2015.
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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.
Kyung Cheon Lee, M.D study director
Gachon Universiy Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inverse ratio ventilation in people with Hypoxia, run by Gachon University Gil Medical Center 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 1 Sep 2015. 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?
Arterial oxygenation (PaO2) (time frame: baseline PaO2-2hour after pneumoperitoneum). 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 1 Sep 2015.