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conventional I:E ratio group, inspiratory time : expiratory time = 1:1

1:1 I:E ratio group, inspiratory time : expiratory time = 1:1

inverse ratio group, inspiratory time : expiratory time = 2:1

I:E ratio of 1:2 with external PEEP of 5 cm H2O

conventional I:E ratio of 1:2 is applied.

conventional I:E ratio

1:1 ratio

2:1 group

external positive end-expiratory pressure of 5 cmH2O is applied.

external PEEP

Tae Soo Hahm, M.D.,Ph.D.

Won Ho Kim, M.D.

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.

The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position

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

physiologic dead space / tidal volume (VD/VT)

Samsung Medical Center

Professor

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma

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Pharmaceutical Solutions

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Plasma-lyte 148

Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Patients who received \> 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.

The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Restrictive group

A group of patients who received \> 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.

The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Liberal group

Maja Karaman Ilić, MD PhD

An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.

A convenience sample of 16 patients admitted to the Department of Thoracic surgery University Hospital Centre Zagreb and scheduled for esophageal carcinoma surgery were enrolled prospectively in the study between June 2011 and August 2012.

Patients were randomly allocated into two groups, one of which received ≤ 8ml/kg/h of intraoperative fluid ("restrictive group") and another that received \> 8 ml/kg/h of fluid ("liberal group").

Patients were excluded if they were younger than 18 years; if they had severe lung disease, chronic renal insufficiency, or a physical status classification \> III on the American Society of Anesthesiologists (ASA) scale; or if it was impossible to perform epidural catheter placement or thoraco-phreno-laparotomy.

All patients underwent esophagectomy carried out according to the Lewis-Tanner approach.

Data on arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the ratio PaO2/FiO2 were collected 10 min after anesthesia was induced and again 6 h after surgery. Data on the metabolic markers creatinine and lactate were collected 10 min after anesthesia induction and 6 h after surgery.

ANOVA tests were performed to determine significant differences in mean values between study groups. Independent-sample t-tests were used to test differences in mean values between the restrictive and liberal groups for each of the two sets of measurements separately (10 minutes after anesthesia induction and 6 hr after surgery). P \< 0.05 was considered significant.

Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial

At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.

At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.

At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.

At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).

Total time of Lewis-Tanner procedure will be measured and compared between two groups.

Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.

Klinički Bolnički Centar Zagreb

MD PhD

Restrictive Group

Liberal Group

Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.

The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Liberal group: A group of patients who received \> 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.

The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Total

Age, Continuous

Sex: Female, Male

The American Society of Anesthesiologists (ASA) Physical Status classification system consists of six categories, as described below:

ASA PS 1: Normal healthy patient. ASA PS 2: Patients with mild systemic disease. ASA PS 3: Patients with severe systemic disease. ASA PS 4: Patients with severe systemic disease that is a constant threat to life. ASA PS 5: Moribund patients who are not expected to survive without the operation. ASA PS 6: A declared brain-dead patient who organs are being removed for donor purposes.

Smaller number is better.

ASA score

Body weight

Small number of participants due to small overall number of patients with esophageal cancer treated in our hospital.

The measurement was assessed at 10 minutes time point.

The measurement was assessed at 6 hours time point.

10 minutes

6 hours

Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)

Creatinine Values During and After Esophageal Carcinoma Surgery

The measurement aws assessed at 10 minutes time point.

Lactate Values During and After Esophageal Carcinoma Surgery

Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.

Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.

The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Patients who received \> 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Liberal group: A group of patients who received \> 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.

The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Duration of Surgery

Total Volume of Administered Intraoperative Fluid

Overall Study

Lung Neoplasms

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

Conventional I:E ratio

I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model

I:E = 1:1 ratio

Sangmin M. Lee, MD, PhD

Won Ho Kim, MD

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position	NCT01379313	Uterine Myoma Ovarian Cyst Laparoscopic Gy...	conventional I:... 1:1 ratio 2:1 group external PEEP	20 Years - 65 Years	Samsung Medical Center
Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial	NCT02033213	Esophageal Neop...	Restrictive gro... Liberal group	18 Years -	Klinički Bolnički Centar Zagreb
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position	NCT01379313	Uterine Myoma Ovarian Cyst Laparoscopic Gy...	conventional I:... 1:1 ratio 2:1 group external PEEP	20 Years - 65 Years	Samsung Medical Center
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery	NCT01540201	Lung Cancer One Lung Ventil... Gas Exchange Inverse-ratio V...	Conventional I:... I:E = 1:1 ratio	20 Years - 70 Years	Samsung Medical Center
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery	NCT01540201	Lung Cancer One Lung Ventil... Gas Exchange Inverse-ratio V...	Conventional I:... I:E = 1:1 ratio	20 Years - 70 Years	Samsung Medical Center
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery	NCT01540201	Lung Cancer One Lung Ventil... Gas Exchange Inverse-ratio V...	Conventional I:... I:E = 1:1 ratio	20 Years - 70 Years	Samsung Medical Center

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