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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01540201
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
8
Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional I:E ratio
  • Other: I:E = 1:1 ratio
 N/A

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

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Official Title:
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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:
  • I:E ratio of 1:1
  • Ventilator : Datex-Ohmeda Aestiva/5 ® model

    		•

    Outcome Measures

    Primary Outcome Measures

    1. arterial CO2 partial pressure [10 minutes after induction of general anesthesia]

      arteial CO2 partial pressure

    2. arterial CO2 partial pressure [30 minutes after start of one-lung ventilation]

      arteial CO2 partial pressure

    3. arterial CO2 partial pressure [60 minutes after start of one-lung ventilation]

      arteial CO2 partial pressure

    4. arterial CO2 partial pressure [15 min after restart of TLV]

      arteial CO2 partial pressure

    5. arterial CO2 partial pressure [1 hour after the end of surgery]

      arteial CO2 partial pressure

    Secondary Outcome Measures

    1. 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]

      arterial O2 partial pressure

    2. 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]

      Mean airway pressure

    3. 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]

      tidal volume (exhaled)

    4. hemodynamic parameters [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

    5. 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]

      end-tidal CO2 partial pressure

    6. respiratory compliance [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

    7. Dead space [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)

    8. 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]

      work of breathing

    9. 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]

      peak inspiratory pressure

    10. plateau 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

    11. 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]

      positive end-expiratory pressure

    12. minute ventilation [10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation]

      minute ventilation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Sangmin M. Lee, MD, PhD, Samsung Medical Center
    • Study Director: Won Ho Kim, MD, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sangmin M. Lee, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01540201
    Other Study ID Numbers:
    • 2011-12-033-002
    First Posted:
    Feb 28, 2012
    Last Update Posted:
    Dec 25, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Sangmin M. Lee, Professor, Samsung Medical Center
    one lung ventilation
    gas exchange
    inverse-ratio ventilation

    Study Results

    No Results Posted as of Dec 25, 2013