The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery

December 24, 2013 updated by: Sangmin M. Lee, Samsung Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing elective lung lobectomy surgery.
  • the duration of one-lung ventilation is more than one hour.
  • subjects with more than twenty years old.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1:2 group
conventional I:E ratio group, inspiratory time : expiratory time = 1:1
Other: Conventional I:E ratio
conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model
Other Names:
  • I:E ratio of 1:2
  • Ventilator : Datex-Ohmeda Aestiva/5 ® model
Experimental: 1:1 group
inspiratory time : expiratory time = 1:1
Other: I:E = 1:1 ratio
I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model
Other Names:
  • Ventilator : Datex-Ohmeda Aestiva/5 ® model
  • I:E ratio of 1:1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
arterial CO2 partial pressure
Time Frame: 10 minutes after induction of general anesthesia
arteial CO2 partial pressure
10 minutes after induction of general anesthesia
arterial CO2 partial pressure
Time Frame: 30 minutes after start of one-lung ventilation
arteial CO2 partial pressure
30 minutes after start of one-lung ventilation
arterial CO2 partial pressure
Time Frame: 60 minutes after start of one-lung ventilation
arteial CO2 partial pressure
60 minutes after start of one-lung ventilation
arterial CO2 partial pressure
Time Frame: 15 min after restart of TLV
arteial CO2 partial pressure
15 min after restart of TLV
arterial CO2 partial pressure
Time Frame: 1 hour after the end of surgery
arteial CO2 partial pressure
1 hour after the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Dynamic compliance, Static compliance
10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
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
arterial O2 partial pressure
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
Mean airway pressure
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
tidal volume (exhaled)
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
systolic/ diastolic blood pressure, heart rate, mean blood pressure
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
end-tidal CO2 partial pressure
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
physiologic dead space / tidal volume (VD/VT)
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
work of breathing
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
peak inspiratory pressure
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
plateau pressure
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
positive end-expiratory pressure
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
minute ventilation
10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Won Ho Kim, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-12-033-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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