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Completed

NCT Number: NCT01540201

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional I:E ratio

Other

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

I:E = 1:1 ratio

Other

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

Primary outcomes

  1. arterial CO2 partial pressure

    Time frame: 10 minutes after induction of general anesthesia

    arteial CO2 partial pressure

  2. arterial CO2 partial pressure

    Time frame: 30 minutes after start of one-lung ventilation

    arteial CO2 partial pressure

  3. arterial CO2 partial pressure

    Time frame: 60 minutes after start of one-lung ventilation

    arteial CO2 partial pressure

  4. arterial CO2 partial pressure

    Time frame: 15 min after restart of TLV

    arteial CO2 partial pressure

  5. arterial CO2 partial pressure

    Time frame: 1 hour after the end of surgery

    arteial CO2 partial pressure

Secondary outcomes

  1. 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

    arterial O2 partial pressure

  2. 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

    Mean airway pressure

  3. 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

    tidal volume (exhaled)

  4. 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

    systolic/ diastolic blood pressure, heart rate, mean blood pressure

  5. 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

    end-tidal CO2 partial pressure

  6. 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

    Dynamic compliance, Static compliance

  7. 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

    physiologic dead space / tidal volume (VD/VT)

  8. 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

    work of breathing

  9. 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

    peak inspiratory pressure

  10. 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

    plateau pressure

  11. 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

    positive end-expiratory pressure

  12. 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

    minute ventilation

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 28, 2012
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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