Comparison of Different Ventilation Mode During One-lung Ventilation

Study Overview
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Brief Summary
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It is controversial as to which ventilation mode is better in one-lung ventilation(OLV), volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was designed to figure out if there was any difference between these two modes on oxygenation and postoperative complications under the condition of protective ventilation(PV).

Detailed Description
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This is a single center, single blinded prospective study on two different ventilation mode during one lung ventilation for patients under video assistant thoracoscopy(VATS) lobectomy. After institutional approval and written informed consent were obtained, 60 patients with primary lung cancer under VATS lobectomy in Zhongshan Hospital Fudan University were enrolled and randomized into two groups:VCV group(group V) or PCV group(group P). Inclusion criteria were age between 18-75 years , ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted. Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs.

Official Title
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Comparison of Pressure-controlled Ventilation With Volume-controlled Ventilation During One-lung Ventilation

Conditions
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Thoracic Surgery, One Lung Ventilation, Ventilator-Induced Lung Injury

Intervention / Treatment
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* Other: VCV mode
* Other: PCV mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted Exclusion Criteria: Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: volume controlled ventilation (VCV)<br>VCV mode, tide volume 6ml/kg, f 12-14, set fixed tide volume for each breath | Other: VCV mode<br>* set fixed 6ml/kg tide volume<br>|
| Experimental: pressure controlled ventilation (PCV)<br>PCV mode, pressure is adjusted to achieve tide volume 6ml/kg, f 12-14 | Other: PCV mode<br>* adjust pressure to achieve tide volume of 6ml/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway pressure Ppeak | Airway pressure Ppeak in cmH2O. | during procedure | 
| Airway pressure Pplat | Airway pressure Pplat in cmH2O. | during procedure | 
| oxygenation index | Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is measured by gas monitor. | during procedure | 
| oxygenation index | Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is calculated by [21+4×oxygen flow(L/min)]×100%. | surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | including air leak, pneumonia, bronchopleural fistula, respiratory failure, ARDS, reintubation, tracheostomy, pulmonary embolism, arrhythmia requiring treatment, myocardial infarction, renal dysfunction, central neurologic event, sepsis, unexpected return to operating room, unexpected ICU admission and mortality within 30 days | within 30 days after surgery |