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

This study is currently recruiting participants.
Verified October 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01540201
First received: February 16, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Lung Cancer
One Lung Ventilation
Gas Exchange
Inverse-ratio Ventilation
 Other: Conventional I:E ratio
Other: I:E = 1:1 ratio

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • arterial CO2 partial pressure [ Time Frame: 10 minutes after induction of general anesthesia ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure

  • arterial CO2 partial pressure [ Time Frame: 30 minutes after start of one-lung ventilation ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure

  • arterial CO2 partial pressure [ Time Frame: 60 minutes after start of one-lung ventilation ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure

  • arterial CO2 partial pressure [ Time Frame: 15 min after restart of TLV ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure

  • arterial CO2 partial pressure [ Time Frame: 1 hour after the end of surgery ] [ Designated as safety issue: No ]
    arteial CO2 partial pressure


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    arterial O2 partial pressure

  • 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 ] [ Designated as safety issue: No ]
    Mean airway pressure

  • 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 ] [ Designated as safety issue: No ]
    tidal volume (exhaled)

  • 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 ] [ Designated as safety issue: No ]
    systolic/ diastolic blood pressure, heart rate, mean blood pressure

  • 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 ] [ Designated as safety issue: No ]
    end-tidal CO2 partial pressure

  • 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 ] [ Designated as safety issue: No ]
    Dynamic compliance, Static compliance

  • 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 ] [ Designated as safety issue: No ]
    physiologic dead space / tidal volume (VD/VT)

  • 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 ] [ Designated as safety issue: No ]
    work of breathing

  • 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 ] [ Designated as safety issue: No ]
    peak inspiratory pressure

  • 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 ] [ Designated as safety issue: No ]
    plateau pressure

  • 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 ] [ Designated as safety issue: No ]
    positive end-expiratory pressure

  • 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 ] [ Designated as safety issue: No ]
    minute ventilation


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540201

Contacts
Contact: Sangmin M. Lee, MD, PhD 82-2-3410-2470 sangminm.lee@samsung.com
Contact: Won Ho Kim, MD 82-2-3410-1994 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sangmin M. Lee, MD, PhD     82-2-3410-2470     sangminm.lee@samsung.com    
Contact: Won Ho Kim, MD     82-2-3410-1994     bullet57@naver.com    
Principal Investigator: Sangmin M. Lee, M.D.,Ph.D.            
Sub-Investigator: Won Ho Kim, M.D.            
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
  More Information

No publications provided

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01540201     History of Changes
Other Study ID Numbers: 2011-12-033-002
Study First Received: February 16, 2012
Last Updated: October 3, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
one lung ventilation
gas exchange
inverse-ratio ventilation

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013