Lung CancerNCT01540201
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery
A study testing Conventional I:E ratio and I:E = 1:1 ratio in people with Lung Cancer and One Lung Ventilation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Lung Cancer, One Lung Ventilation, Gas Exchange
- What is being tested?
- Conventional I:E ratio and I:E = 1:1 ratio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective lung lobectomy surgery.
- the duration of one-lung ventilation is more than one hour.
- subjects with more than twenty years old.
Who cannot join
- subjects with past history of pneumothorax, asthma
- Age under 20, more than 70 years.
- Patients with ischemic heart disease, valvular heart disease
- patients with hemodynamic unstability
Trial locations and contacts
1 site in 1 country.
About this study
Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with lung protective strategy.
Read the detailed description
Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. Continuous positive airway pressure or positive end-expiratory pressure are usually applied to improve this disorder including hypoxia, but these methods are not enough. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. The application of IRV during OLV has not been performed to our knowledge, and there is a possibility of IRV to improve oxygenation during OLV. There is a possibility of increase of auto-PEEP, or air trapping in subjects with chronic obstructive pulmonary disease, but this kind of auto-PEEP can be overcome by external PEEP. Therefore, we tried to evaluate the effect of IRV during OLV with lung protective strategy.
- Being tested
- Conventional I:E ratio, I:E = 1:1 ratio
- Keywords
- one lung ventilation, gas exchange, inverse-ratio ventilation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional I:E ratioOther
Also called I:E ratio of 1:2, Ventilator : Datex-Ohmeda Aestiva/5 ® model
conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model
I:E = 1:1 ratioOther
Also called I:E ratio of 1:1, Ventilator : Datex-Ohmeda Aestiva/5 ® model
I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model
| Study group | Role | What they receive |
|---|---|---|
| 1:2 group | Active comparator | conventional I:E ratio group, inspiratory time : expiratory time = 1:1 Receives: Other: Conventional I:E ratio |
| 1:1 group | Experimental | inspiratory time : expiratory time = 1:1 Receives: Other: I:E = 1:1 ratio |
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 one-lung ventilation
arterial CO2 partial pressure
arteial CO2 partial pressure
Measured: 60 minutes after start of one-lung ventilation
arterial CO2 partial pressure
arteial CO2 partial pressure
Measured: 15 min after restart of TLV
arterial CO2 partial pressure
arteial CO2 partial pressure
Measured: 1 hour after the end of surgery
Secondary outcomes (12)
arterial O2 partial pressure
arterial O2 partial pressure
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery
Mean airway pressure
Mean airway pressure
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
tidal volume (exhaled)
tidal volume (exhaled)
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
hemodynamic parameters
systolic/ diastolic blood pressure, heart rate, mean blood pressure
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
end-tidal CO2 partial pressure
end-tidal CO2 partial pressure
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
respiratory compliance
Dynamic compliance, Static compliance
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Dead space
physiologic dead space / tidal volume (VD/VT)
Measured: 10 min after induction, 30 and 60 min after start of one lung ventilation, 15 min after restart of two-lung ventilation
work of breathing
work of breathing
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
peak inspiratory pressure
peak inspiratory pressure
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
plateau pressure
plateau pressure
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
positive end-expiratory pressure
positive end-expiratory pressure
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
minute ventilation
minute ventilation
Measured: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangmin M. Lee, Samsung Medical Center
- Investigators
- Sangmin M. Lee, MD, PhD, Principal investigator, Samsung Medical CenterWon Ho Kim, MD, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540201
- Sponsor's protocol ID
- 2011-12-033-002
- Status last verified
- Dec 2013
- First submitted
- 16 Feb 2012
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. 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 One-lung Ventilation for Lung Surgery
- ClinicalTrials.gov ID
- NCT01540201
- Acronym / sponsor ID
- 2011-12-033-002
- Keywords
- one lung ventilation, gas exchange, inverse-ratio ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Feb 2012 (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.
Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with lung protective strategy.
Detailed description
Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. Continuous positive airway pressure or positive end-expiratory pressure are usually applied to improve this disorder including hypoxia, but these methods are not enough. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. The application of IRV during OLV has not been performed to our knowledge, and there is a possibility of IRV to improve oxygenation during OLV. There is a possibility of increase of auto-PEEP, or air trapping in subjects with chronic obstructive pulmonary disease, but this kind of auto-PEEP can be overcome by external PEEP. Therefore, we tried to evaluate the effect of IRV during OLV with lung protective strategy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:2 group | Active comparator | Other: Conventional I:E ratioconventional I:E ratio group, inspiratory time : expiratory time = 1:1 |
| 1:1 group | Experimental | Other: I:E = 1:1 ratioinspiratory time : expiratory time = 1:1 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective lung lobectomy surgery.
- the duration of one-lung ventilation is more than one hour.
- subjects with more than twenty years old.
Key exclusion criteria (4 listed)
- subjects with past history of pneumothorax, asthma
- Age under 20, more than 70 years.
- Patients with ischemic heart disease, valvular heart disease
- patients with hemodynamic unstability
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 ratioAlso: I:E ratio of 1:2, Ventilator : Datex-Ohmeda Aestiva/5 ® modelconventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model | Other | 1:2 group |
| I:E = 1:1 ratioAlso: I:E ratio of 1:1, Ventilator : Datex-Ohmeda Aestiva/5 ® modelI:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model | Other | 1:1 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 one-lung ventilation
arteial CO2 partial pressure
arterial CO2 partial pressure
Time frame: 60 minutes after start of one-lung ventilation
arteial CO2 partial pressure
arterial CO2 partial pressure
Time frame: 15 min after restart of TLV
arteial CO2 partial pressure
arterial CO2 partial pressure
Time frame: 1 hour after the end of surgery
arteial CO2 partial pressure
12 secondary outcomes
arterial O2 partial pressure
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery
Mean airway pressure
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
tidal volume (exhaled)
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
hemodynamic parameters
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
end-tidal CO2 partial pressure
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
respiratory compliance
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Dead space
Time frame: 10 min after induction, 30 and 60 min after start of one lung ventilation, 15 min after restart of two-lung ventilation
work of breathing
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
peak inspiratory pressure
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
plateau pressure
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
positive end-expiratory pressure
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
minute ventilation
Time frame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
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 25 Dec 2013.
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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.
Sangmin M. Lee, MD, PhD principal investigator
Samsung Medical Center
Won Ho Kim, MD study director
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 and I:E = 1:1 ratio in people with Lung Cancer and One Lung Ventilation, 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 3 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 25 Dec 2013. 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 5 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 25 Dec 2013.