Study Results
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Basic Information
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UNKNOWN
PHASE3
62 participants
INTERVENTIONAL
2019-01-31
2020-06-30
Brief Summary
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SVV is calculated as the variation of beat-to-beat SV from the mean value during the most recent 20 seconds of data: SVV = (SVmax - SVmin)/SVmean, where SVmax, SVmin, and SVmean are, respectively, the maximum, minimum, and mean SV determined by the system.
SVV may not be sufficiently sensitive to predict fluid responsiveness in patients with right ventricular (RV) dysfunction due to concomitant increases in RV afterload, that lead to a decrease in preload variation and subsequent inaccuracy in SVV measurements.8
OLV may increase airway pressure, resulting in increases in the RV afterload, end-diastolic volume, and stroke work index, thus impeding RV function.9-11The increases in the right ventricular afterload may exaggerate the cyclic variation in stroke volume.12
In the authors' previous study,9 they found that the high-frequency positive-pressure ventilation (HFPPV) was superior to continuous positive-airway pressure (CPAP) for OLV, resulting in significantly higher RV ejection fraction, lower RV afterload and higher arterial oxygenation, whereas the former limiting the adequate operative field visualization during video-assisted thoracoscopic surgery (VATS).13
The effects of the nondependent lung ventilation with HFPPV and CPAP on the SVV and fluid responsiveness during OLV has not yet been studied.
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Detailed Description
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Cisatracurium (0.2mg kg-1) will be administered to facilitate the placement of a left-sided double-lumen tube, and the correct position of its tip will be confirmed with a fiberoptic bronchoscope.
Anesthesia will be maintained with 0.7 to 1.5 minimum alveolar concentration of sevoflurane and 0.5 µg kg-1 increments of fentanyl to maintain the SE values less than 50 and the difference between RE and SE less than 10. Suppression of the second twitch in train-of-four stimulation of the ulnar nerve will be maintained with 0.03mg kg-1 increments of cisatracurium.
The radial artery will be catheterized. Cardiac index (CI) and SVV will be measured by using a Vigileo-FloTrac system (v1.14, Edwards Lifescience, Irvine, CA).
Patients' two lungs (TLV) will be mechanically ventilated with a pressure-controlled ventilation mode, a fraction of inspired oxygen (FiO2) of 0.4 in air, TV of 8 mL kg-1 (predicted body weight (PBW)), inspiratory to expiratory (I: E) ratio of 1:2.5 and PEEP of 5 cm H2O, fresh gas flow (FGF) of 1.5-1.7 L min-1, and RR adjusted to achieve a PaCO2 of 35-45 mm Hg.
During OLV,TV, FiO2, I: E ratio, PEEP, FGF, and RR, will be maintained as during TLV and the lumen of the nondependent lung will be left open to air.
After thoracostomy, patients will be randomly allocated to one of two by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code.
The patient's nondependent lung during OLV will be ventilated with a CPAP of 2 cm H2O or HFPPV as randomized.
All patients will receive lactated Ringer's solution at 2mL kg-1 h-1 during surgery. The capability of SVV to predict fluid responsiveness during CPAP or HFPPV will be assessed at 30 min after randomization.
Hemodynamic control will be standardized according to the authors' protocol. If MAP dropped down to 60 mmHg, 250 mL of plasma protein fraction 5% will be administered, and, if this will not enough, repeated doses of intravenous of ephedrine 5 mg or phenylephrine 100 µg, will be administered to maintain urine output to be equal or greater than 0.5 mL kg-1 hour-1. A hemoglobin concentration of 8 g dL-1 or greater will be compensated with red blood cell concentrates.
An independent investigator blinded to the study groups who will not be involved in the patients' management collected the data.
As in previous studies,14-15 the sample size is determined by considering that an area under the ROC curve ≥ 0.8 is clinically reliable to predict fluid responsiveness. To detect a 0.3 difference from the null hypothesis of 0.5, 28 patients will be required in each group with a type-I error of 0.05 and a power of 80% under the ROC curve, assuming equal number of responders and non-responders. To compensate for a dropout rate of 10%, 31 patients will be included in each group.
Normal distributions of data will be assessed using Kolmogorov-Smirnov test. Student's paired t-test or the Wilcoxon signed-rank test will be used to compare hemodynamic variables obtained at the 2 time points (T0, T1) before and after volume expansion. Hemodynamic variables between responders and non-responders within the group at each time point will be compared using Student independent t-test or Mann-Whitney U-test where appropriate. The x2 test will be used when indicated. The Pearson rank method tests linear correlations between SVV before volume loading (T0) and absolute changes in SVV (∆SVV) and percentage change in SVI (∆SVI) after volume. The responders are defined as those patients who demonstrates a ≥ 15% increase in CI after volume expansion between T0 and T1.16 A ROC curve for each variable will be generated and an area under the ROC curve will be calculated. Using this analysis, the optimal threshold value, sensitivity and specificity of SVV during each study intervention could be determined. The ROC curves will be compared using the DeLong test. Data will be expressed as mean ± SD, medians \[IQR\], or number (%). A value of p\< 0.05 is considered to be statistically significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High Frequency Positive Pressure Ventilation
High Frequency Positive Pressure Ventilation
TV 2 mL kg-1 PBW, I:E ratio \> 0.3, RR 60 breaths min-1 and a FGF of \< 2 L min-1, using a second identical ventilator with low compliant internal circuit
Continuous Positive Airway Pressure
Continuous Positive Airway Pressure
CPAP of 2 cm H2O
Interventions
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High Frequency Positive Pressure Ventilation
TV 2 mL kg-1 PBW, I:E ratio \> 0.3, RR 60 breaths min-1 and a FGF of \< 2 L min-1, using a second identical ventilator with low compliant internal circuit
Continuous Positive Airway Pressure
CPAP of 2 cm H2O
Eligibility Criteria
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Inclusion Criteria
* Duration of OLV is expected to exceed 1.5 hours
Exclusion Criteria
* Right ventricular dysfunction
* Pulmonary hypertension
* valvular heart disease
* intracardiac shunts
* Any cardiac rhythm other than sinus
* Hypertension
* Diabetes mellitus
* Renal dysfunction
* Hepatic dysfunction
* Pregnancy
* Body mass index \>35 kg m-2
* Peripheral arterial occlusive disease
* preoperative administration of inotropic medications
18 Years
70 Years
ALL
No
Sponsors
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Imam Abdulrahman Bin Faisal University
OTHER
Responsible Party
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Principal Investigators
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Abdulmohsen A Al Ghamdi, MD
Role: STUDY_CHAIR
Chairman of Anesthesiology Dept
Mohamed R El Tahan, MD
Role: PRINCIPAL_INVESTIGATOR
Imam Abdulrahman Bin Faisal University
Locations
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King Fahd Hospital of the University
Khobar, Eastern Province, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N2014045
Identifier Type: -
Identifier Source: org_study_id
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