Clinical trial NCT01540201: The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery
Official title: The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
One Lung Ventilation
Gas Exchange
Inverse-ratio Ventilation
Keywords: one lung ventilation
gas exchange
inverse-ratio ventilation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: arterial CO2 partial pressure
timeFrame: 10 minutes after induction of general anesthesia
measure: arterial CO2 partial pressure
timeFrame: 30 minutes after start of one-lung ventilation
measure: arterial CO2 partial pressure
timeFrame: 60 minutes after start of one-lung ventilation
measure: arterial CO2 partial pressure
timeFrame: 15 min after restart of TLV
measure: arterial CO2 partial pressure
timeFrame: 1 hour after the end of surgery
Secondary outcomes:
measure: arterial O2 partial pressure
timeFrame: 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
measure: Mean airway pressure
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: tidal volume (exhaled)
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: hemodynamic parameters
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: end-tidal CO2 partial pressure
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: respiratory compliance
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: Dead space
timeFrame: 10 min after induction, 30 and 60 min after start of one lung ventilation, 15 min after restart of two-lung ventilation
measure: work of breathing
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: peak inspiratory pressure
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: plateau pressure
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: positive end-expiratory pressure
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
measure: minute ventilation
timeFrame: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sangmin M. Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, MD
role: STUDY_DIRECTOR
References: