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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540201
• Other study ID #: 2011-12-033-002
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: December 24, 2013
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Gas Exchange
• Inverse-ratio Ventilation
• Lung Cancer
• One Lung Ventilation

Intervention

Other:
• Conventional I:E ratio
conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model
• I:E = 1:1 ratio
I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	10 minutes after induction of general anesthesia	No
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	30 minutes after start of one-lung ventilation	No
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	60 minutes after start of one-lung ventilation	No
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	15 min after restart of TLV	No
Primary	arterial CO2 partial pressure	arteial CO2 partial pressure	1 hour after the end of surgery	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No