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

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: Completed
• Conditions: Lung Cancer; One Lung Ventilation; Gas Exchange; Inverse-ratio Ventilation
• Intervention / Treatment: Other: Conventional I:E ratio; Other: I:E = 1:1 ratio

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: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Ventilator : Datex-Ohmeda Aestiva/5 ® model; I:E ratio of 1:1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial CO2 partial pressure	arteial CO2 partial pressure	10 minutes after induction of general anesthesia
arterial CO2 partial pressure	arteial CO2 partial pressure	30 minutes after start of one-lung ventilation
arterial CO2 partial pressure	arteial CO2 partial pressure	60 minutes after start of one-lung ventilation
arterial CO2 partial pressure	arteial CO2 partial pressure	15 min after restart of TLV
arterial CO2 partial pressure	arteial CO2 partial pressure	1 hour after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory compliance	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	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	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)	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	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	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	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	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	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	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	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	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

• Sponsor: Samsung Medical Center
• Investigators: Study Director: Won Ho Kim, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): February 28, 2012

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: one lung ventilation; gas exchange; inverse-ratio ventilation
• Other Study ID Numbers: 2011-12-033-002