Uterine MyomaNCT01379313
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position
A study testing conventional I:E ratio, 1:1 ratio and 2:1 group in people with Uterine Myoma and Ovarian Cyst, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Uterine Myoma, Ovarian Cyst, Laparoscopic Gynecologic Surgery
- What is being tested?
- conventional I:E ratio, 1:1 ratio and 2:1 group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Mar 2012
- 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
- patients undergoing elective gynecologic laparoscopic surgery
- the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes
Who cannot join
- ASA (American society of anesthesiologists) classification of the subjects more than III.
- Age under 20, or more than 65 years.
- Past history of pneumothorax, COPD, asthma.
- Patients with ischemic heart disease, valvular heart disease.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Seoul Hospital, Samsung Medical Center
Seoul, 135-710
About this study
In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.
Read the detailed description
In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.
- Being tested
- conventional I:E ratio, 1:1 ratio, 2:1 group, external PEEP
- Keywords
- laparoscopic gynecologic surgery, gas exchange, inspiratory time, expiratory time, I:E ratio
- Medical subject headings
- Myofibroma, Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional I:E ratioProcedure or surgery
conventional I:E ratio of 1:2 is applied.
1:1 ratioProcedure or surgery
I:E ratio of 1:1 is applied.
2:1 groupProcedure or surgery
Inverse I:E ratio of 2:1 is applied.
external PEEPProcedure or surgery
external positive end-expiratory pressure of 5 cmH2O is applied.
| Study group | Role | What they receive |
|---|---|---|
| 1:2 group | Active comparator | conventional I:E ratio group, inspiratory time : expiratory time = 1:1 Receives: Procedure: conventional I:E ratio |
| 1:1 group | Experimental | 1:1 I:E ratio group, inspiratory time : expiratory time = 1:1 Receives: Procedure: 1:1 ratio |
| 2:1 group | Experimental | inverse ratio group, inspiratory time : expiratory time = 2:1 Receives: Procedure: 2:1 group |
| 1:2 PEEP group | Active comparator | I:E ratio of 1:2 with external PEEP of 5 cm H2O Receives: Procedure: conventional I:E ratio; Procedure: external PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial CO2 partial pressure
arteial CO2 partial pressure
Measured: 10 minutes after induction of general anesthesia
arterial CO2 partial pressure
arteial CO2 partial pressure
Measured: 30 minutes after start of pneumoperitoneum
arterial CO2 partial pressure
arteial CO2 partial pressure
Measured: 60 minutes after start of pneumoperitoneum
Secondary outcomes (13)
arterial O2 partial pressure
arterial O2 partial pressure
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Mean airway pressure
Mean airway pressure
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (setting)
tidal volume (setting)
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
hemodynamic parameters
systolic/ diastolic blood pressure, heart rate, mean blood pressure
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
end-tidal CO2 partial pressure
end-tidal CO2 partial pressure
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
respiratory compliance
Dynamic compliance, Static compliance
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Dead space
physiologic dead space / tidal volume (VD/VT)
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
work of breathing
work of breathing
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
peak inspiratory pressure
peak inspiratory pressure
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
plateau pressure
plateau pressure
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
positive end-expiratory pressure
positive end-expiratory pressure
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (exhaled)
tidal volume (exhaled)
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
minute ventilation
minute ventilation
Measured: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine MyomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Soo Hahm, Samsung Medical Center
- Investigators
- Tae Soo Hahm, M.D.,Ph.D., Study director, Samsung Medical CenterWon Ho Kim, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379313
- Sponsor's protocol ID
- 2011-04-007
- Status last verified
- Sep 2012
- First submitted
- 21 Jun 2011
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position
- ClinicalTrials.gov ID
- NCT01379313
- Acronym / sponsor ID
- 2011-04-007
- Keywords
- laparoscopic gynecologic surgery, gas exchange, inspiratory time, expiratory time, I:E ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Jun 2011 (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.
In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.
Detailed description
In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1:2 group | Active comparator | Procedure: conventional I:E ratioconventional I:E ratio group, inspiratory time : expiratory time = 1:1 |
| 1:1 group | Experimental | Procedure: 1:1 ratio1:1 I:E ratio group, inspiratory time : expiratory time = 1:1 |
| 2:1 group | Experimental | Procedure: 2:1 groupinverse ratio group, inspiratory time : expiratory time = 2:1 |
| 1:2 PEEP group | Active comparator | Procedure: conventional I:E ratio, Procedure: external PEEPI:E ratio of 1:2 with external PEEP of 5 cm H2O |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing elective gynecologic laparoscopic surgery
- the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes
Key exclusion criteria (4 listed)
- ASA (American society of anesthesiologists) classification of the subjects more than III.
- Age under 20, or more than 65 years.
- Past history of pneumothorax, COPD, asthma.
- Patients with ischemic heart disease, valvular heart 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 |
|---|---|---|
| conventional I:E ratioconventional I:E ratio of 1:2 is applied. | Procedure or surgery | 1:2 PEEP group, 1:2 group |
| 1:1 ratioI:E ratio of 1:1 is applied. | Procedure or surgery | 1:1 group |
| 2:1 groupInverse I:E ratio of 2:1 is applied. | Procedure or surgery | 2:1 group |
| external PEEPexternal positive end-expiratory pressure of 5 cmH2O is applied. | Procedure or surgery | 1:2 PEEP group |
Primary outcome
arterial CO2 partial pressure
Time frame: 10 minutes after induction of general anesthesia
arteial CO2 partial pressure
arterial CO2 partial pressure
Time frame: 30 minutes after start of pneumoperitoneum
arteial CO2 partial pressure
arterial CO2 partial pressure
Time frame: 60 minutes after start of pneumoperitoneum
arteial CO2 partial pressure
13 secondary outcomes
arterial O2 partial pressure
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Mean airway pressure
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (setting)
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
hemodynamic parameters
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
end-tidal CO2 partial pressure
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
respiratory compliance
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Dead space
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
work of breathing
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
peak inspiratory pressure
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
plateau pressure
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
positive end-expiratory pressure
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (exhaled)
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
minute ventilation
Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
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 Oct 2012.
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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.
Tae Soo Hahm, M.D.,Ph.D. study director
Samsung Medical Center
Won Ho Kim, M.D. principal investigator
Samsung 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 conventional I:E ratio, 1:1 ratio and 2:1 group in people with Uterine Myoma and Ovarian Cyst, run by Samsung 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 2 inclusion and 4 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 Oct 2012. 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 CO2 partial pressure (time frame: 10 minutes after induction of general anesthesia). The study lists 3 primary outcomes in all. 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 Oct 2012.