Nondependent Lung Ventilation and Fluid Responsiveness
Primary Purpose
Lung Disease, Undergoing Thoracosocpic Surgery
Status
Unknown status
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
High Frequency Positive Pressure Ventilation
Continuous Positive Airway Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease focused on measuring Video-assisted thoracoscopic surgery, one-lung ventilation, continuous positive-airway ventilation, high-frequency positive-pressure ventilation, stroke volume variation, fluid responsiveness
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists physical class of II to III
- Duration of OLV is expected to exceed 1.5 hours
Exclusion Criteria:
- New York Heart Association class > II
- 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
Sites / Locations
- King Fahd Hospital of the University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
High Frequency Positive Pressure Ventilation
Continuous Positive Airway Pressure
Arm Description
Outcomes
Primary Outcome Measures
Fluid responsiveness
To explore the ability of SVV to predict fluid responsiveness with ROC plots
Secondary Outcome Measures
Heart rate
Stroke volume variation
Mean blood pressure
Cardiac index
Stroke Volume Index
Airway pressures
Lung Compliance
Full Information
NCT ID
NCT02191410
First Posted
July 12, 2014
Last Updated
May 22, 2018
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT02191410
Brief Title
Nondependent Lung Ventilation and Fluid Responsiveness
Official Title
Comparative Study of the Non-dependent Continuous Positive Airway Pressure and High-frequency Positive-pressure Ventilation on Fluid Responsiveness During One-lung Ventilation for Thoracoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The stroke volume variation (SVV), measured using the Vigileo-FloTrac system (Edwards Lifescience, Irvine, CA), has been shown to able to predict fluid responsiveness during one-lung ventilation (OLV) in patients undergoing pulmonary lobectomy (sensitivity: 82.4%, specificity: 92.3%).1 Many parameters such as tidal volume (TV),1-2 positive end-expiratory pressure (PEEP),3 respiratory rate (RR), 4 chest and lung compliance,5 heart rate and rhythm, and ventricular function and afterload,6-7 all have been documented to have effects on the SVV.
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.
Detailed Description
In all patients, standard monitors, and state and response entropy (SE and RE, respectively) based-depth of anesthesia will be applied. Normothermia will be maintained by using forced-air warming blankets. Anesthetic technique will be standardized in all studied patients. Anesthesiologists who give the anesthetic will be not involved in the collection of outcome data. General anesthesia will be induced with propofol (2-3 mg kg-1) and fentanyl (2-3 µg kg-1) to achieve a SE value less than 50 and the difference between RE and SE less than 10.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease, Undergoing Thoracosocpic Surgery
Keywords
Video-assisted thoracoscopic surgery, one-lung ventilation, continuous positive-airway ventilation, high-frequency positive-pressure ventilation, stroke volume variation, fluid responsiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Frequency Positive Pressure Ventilation
Arm Type
Active Comparator
Arm Title
Continuous Positive Airway Pressure
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
High Frequency Positive Pressure Ventilation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
CPAP of 2 cm H2O
Primary Outcome Measure Information:
Title
Fluid responsiveness
Description
To explore the ability of SVV to predict fluid responsiveness with ROC plots
Time Frame
5 min after volume loading
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
5 min before volume loading, 5 min after volume loading
Title
Stroke volume variation
Time Frame
5 min before volume loading, 5 min after volume loading
Title
Mean blood pressure
Time Frame
5 min before volume loading, 5 min after volume loading
Title
Cardiac index
Time Frame
5 min before volume loading, 5 min after volume loading
Title
Stroke Volume Index
Time Frame
5 min before volume loading, 5 min after volume loading
Title
Airway pressures
Time Frame
5 min before volume loading, 5 min after volume loading
Title
Lung Compliance
Time Frame
5 min before volume loading, 5 min after volume loading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists physical class of II to III
Duration of OLV is expected to exceed 1.5 hours
Exclusion Criteria:
New York Heart Association class > II
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed R El Tahan, MD
Phone
+966 13 865 1193
Email
mohamedrefaateltahan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulmohsin A Al Ghamdi, MD
Phone
+966 50 581 4737
Email
mohsenkfu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdulmohsen A Al Ghamdi, MD
Organizational Affiliation
Chairman of Anesthesiology Dept
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed R El Tahan, MD
Organizational Affiliation
Imam Abdulrahman Bin Faisal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Fahd Hospital of the University
City
Khobar
State/Province
Eastern
ZIP/Postal Code
31952
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulmohsen A Al Ghamdi, MD
Phone
+966 13 8966666
Ext
2021
Email
mohsenkfu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed R El Tahan, MD
First Name & Middle Initial & Last Name & Degree
Abdulmohsen A Al Ghamdi, MD
12. IPD Sharing Statement
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Nondependent Lung Ventilation and Fluid Responsiveness
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