Colorectal NeoplasmsNCT01897584
Effect Inverse Ratio Ventilation on Arterial Oxygenation and Respiratory Mechanics During lapaLAR
A study testing inverse IE in people with Colorectal Neoplasms, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- inverse IE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colorectal cancer
Who cannot join
- obesity (BMI>35), uncontrolled hypertension, coronary artery disease, uncompensated cardiovascular disease, current respiratory disease, open procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inverse Ratioventilation on Laparoscopic Low Anterior Resection
Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics
Read the detailed description
Inverse ratio ventilation already known as effective to improve the oxygenation and respiratory mechanics in the ARDS patients. Recently, there were report of decrease in airway pressure and improve in respiratory compliance during inverse ration ventilation undergoing one lung ventilation. We hypothesized that changes of inspiration and expiration ratio from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics in the patients who undergoing laparoscopic low anterior resection. However, prolonged inspiratory time might compromise cerebral perfusion pressure due to an elevation in central venous pressure and concomitant reductions in mean arterial pressure.
- Conditions
- Colorectal Neoplasms
- Being tested
- inverse IE
- Keywords
- laparoscopy, Trendelenburg Position, ventilation
- Medical subject headings
- Colorectal Neoplasms, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inverse IEOther
Also called inverse I:E
in only one group changes of I:E ratio would be applied
| Study group | Role | What they receive |
|---|---|---|
| Inverse IE | Experimental | in only one group, inspiration to expiration ratio 1:2 to 1:1 will be applied during pneumoperitoneum Receives: Other: inverse IE |
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 will be analyzed 10 min after anesthetic induction, 20 min after pneumoperitoneum, 40 min after pneumoperitoneum and operation end.
Measured: baseline PaO2- 2 hour after pneumoperitoneum
Secondary outcomes (1)
cerebral perfusion pressure
cerebral perfusion pressure would calculate as mean arterial pressure-central venous pressure from immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1.
Measured: immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 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 Colorectal NeoplasmsStudies 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
- None (open label)
- 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
- Hyun Jeong Kwak, M.D., Ph.D, Study director, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897584
- Sponsor's protocol ID
- GBIRB2013-127
- Other IDs
- GBIRB2013-127
- Status last verified
- Aug 2015
- First submitted
- 26 Jun 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
- Effect of Inverse Ratioventilation on Laparoscopic Low Anterior Resection
- ClinicalTrials.gov ID
- NCT01897584
- Acronym / sponsor ID
- GBIRB2013-127
- Conditions
- Colorectal Neoplasms
- Keywords
- laparoscopy, Trendelenburg Position, ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jul 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.
Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics
Detailed description
Inverse ratio ventilation already known as effective to improve the oxygenation and respiratory mechanics in the ARDS patients. Recently, there were report of decrease in airway pressure and improve in respiratory compliance during inverse ration ventilation undergoing one lung ventilation. We hypothesized that changes of inspiration and expiration ratio from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics in the patients who undergoing laparoscopic low anterior resection. However, prolonged inspiratory time might compromise cerebral perfusion pressure due to an elevation in central venous pressure and concomitant reductions in mean arterial pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inverse IE | Experimental | Other: inverse IEin only one group, inspiration to expiration ratio 1:2 to 1:1 will be applied during pneumoperitoneum |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- colorectal cancer
Key exclusion criteria (1 listed)
- obesity (BMI>35), uncontrolled hypertension, coronary artery disease, uncompensated cardiovascular disease, current respiratory disease, open procedure
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 IEAlso: inverse I:Ein only one group changes of I:E ratio would be applied | Other | Inverse IE |
Primary outcome
arterial oxygenation (PaO2)
Time frame: baseline PaO2- 2 hour after pneumoperitoneum
sampling for arterial blood from arterial cannular will be analyzed 10 min after anesthetic induction, 20 min after pneumoperitoneum, 40 min after pneumoperitoneum and operation end.
1 secondary outcome
cerebral perfusion pressure
Time frame: immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1
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.
Hyun Jeong Kwak, M.D., Ph.D study director
Gachon University 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 IE in people with Colorectal Neoplasms, 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- 2 hour 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.