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Pressure-controlled vs Volume Controlled Ventilation on RV Function During OLV

Primary Purpose

Lung Diseases

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
The PCV-VCV group
The VCV-PCV group
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring Thoracic surgery, one lung ventilation, pressure-controlled ventilation, volume-controlled ventilation, right ventricular function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical class from II to III

Exclusion Criteria:

  • decompensated cardiac (New York Heart Association >II)
  • pulmonary (vital capacity or FEV1% < 50% of the predicted values)
  • asthma
  • hepatic diseases.
  • renal diseases
  • arrhythmias
  • pulmonary hypertension (mean pulmonary artery pressure >30 mm Hg)
  • body mass index >35 kg/m2
  • previous history of pneumonectomy, bilobectomy, or lobectomy

Sites / Locations

  • Anesthesiology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The PCV-VCV group

The VCV-PCV group

Arm Description

The dependent lung will be ventilated with pressure controlled (PCV) followed by the volume-controlled ventilation (VCV)

The dependent lung will be ventilated with volume-controlled ventilation (VCV) followed by the pressure controlled (PCV)

Outcomes

Primary Outcome Measures

Right ventricular function
Peak systolic and diastolic tricuspid annular velocity (TAV)

Secondary Outcome Measures

Blood pressure
Blood pressure
Pa/FiO2 ratio
the ratio between arterial oxygen tension (PaO2)and inspired fraction of oxygen (FiO2)
Airway pressures
Peak and plateau airway pressures
Right ventricular volumes
right ventricular end diastolic and systolic volumes

Full Information

First Posted
December 30, 2012
Last Updated
July 24, 2013
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT01763879
Brief Title
Pressure-controlled vs Volume Controlled Ventilation on RV Function During OLV
Official Title
Right Ventricular Function During One-lung Ventilation: The Effects of Pressure Controlled and Volume Controlled Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The use of pressure controlled ventilation (TV) during one lung ventilation (OLV) for thoracic surgery is associated with comparable oxygenation with volume controlled ventilation (VCV) with added benefits of decreasing airway pressures and shunt fraction. The later may improve the right ventricular (RV) function during OLV. We postulate that the use of PCV during OLV for thoracic surgery would preserve RV function than during VCV. After local ethics committee approval and informed consent, we will randomly allocate 28 patients scheduled for elective thoracic surgery OLV to randomly crossed from PCV to VCV mode (n= 14 for each) during with VT of 6 mL/kg, I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain normocapnia. Intraoperative changes in the right ventricular function (peak systolic and diastolic tricuspid annular velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional area changes (RV-FAC)), hemodynamic and oxygenation parameters, peak and plateau airway pressures, compliance will be recorded.
Detailed Description
One-lung ventilation (OLV) provides excellent operative field for thoracic procedures, but is opposed by the harmful impairment of cardiac index and right ventricular (RV) function which may influence postoperative morbidity and mortality. In our previous study, we demonstrated significant reductions in RV ejection fraction (REF) and CI values after the initiation of OLV attributable to the increased right ventricular afterload, stroke work and end-diastolic volume augmented by increased airway pressures. This may be harmful with the patients with advanced obstructive lung diseases and those with pulmonary hypertension. Thus there is no doubt that decreases in airway pressures will be associated with better RV function. Volume controlled ventilation (VCV) is the commonly used traditional ventilation mode for OLV during thoracic procedures but its use is associated with deleterious increases in airway pressure which may impede RV function. Pressure controlled ventilation (PCV) is an alternative mode of ventilation which is widely used in the patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI), whereby high initial flow rates are delivered to quickly achieve and maintain the set inspiratory pressure followed by rapidly decelerating flow.These high initial flow rates lead to a more rapid alveolar inflation. PCV has been suggested as a useful tool to improve oxygenation as well as decreases in intra-pulmonary shunt (Qs/Qt) and airway pressures compared with VCV during OLV for patients undergoing thoracic surgery. Whereas, others demonstrated comparable arterial oxygenation with the use of PCV and VCV during OLV. However, the use of PCV offers advantages over VCV during OLV in the term of reducing mean and bronchial peak airway pressures and intrapulmonary shunt, hence limiting the risk for barotrauma and impaired RV function. Up to the investigators knowledge, there is no available study of the effects of PCV and VCV on RV function during OLV after thoracic surgery. The investigators hypothesize that the use of PCV during OLV will be associated with preserved RV function than during the use of VCV. They will compare the effects of the use of PCV and VCV with 5 cm H2O level of PEEP and recruitment maneuvers during OLV on the right ventricular function (peak systolic and diastolic tricuspid annular velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional area changes (RV-FAC)), hemodynamic parameters (heart rate (HR), mean arterial blood pressure, (MAP)), oxygenation parameters (arterial oxygen and carbon dioxide tension (PaO2 and PaCO2, respectively), and arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio), ventilation parameters (peak and plateau airway pressures (Ppk and Ppl, respectively) and compliance) and the ICU and hospital length-of-stays, morbidity and 30-day mortality. Sample size calculation: A priori power analysis of the previous published data11 showed that the investigators will need to study 13 pairs to detect a 20% difference in the mean maximal systolic TAV values (7.0 cm/s) with a SD of 1.4 cm/s, after start of OLV, a type-I error of 0.05 and a power of 90%. We will add 10% more patients for a final sample size of 28 patients to account for patients dropping out during the study. Interventions: In all patients, standard monitors will be applied. A thoracic epidural or paravertebral catheter will be inserted with no more use of local anesthetics during the study to avoid their effects on hypoxic pulmonary vasoconstriction.12 An arterial line (20 G) and a right internal jugular vein catheter will be inserted. Anesthetic technique will be standardized in all studied patients. Anesthesiologists who will give the anaesthetic will be not involved in the patient's assessment. General anesthesia will be induced with propofol (2-3 mg/kg), fentanyl (2-3 µg/kg), and cisatracurium (0.2 mg/kg) will be given to facilitate tracheal intubation with a left-sided double-lumen tube (DLT). The correct position of its tip will be confirmed with a fiberoptic bronchoscope. Anesthesia will be maintained with 1-1.5 minimum alveolar concentration (MAC) of sevoflurane and increments of fentanyl (0.5µg/kg) and cisatracurium (0.04 mg/kg). The patients' lungs will be mechanically ventilated using VCV mode, fraction of inspired oxygen (FiO2) of 0.5 in air, tidal volume (VT) of 8 mL/kg (predicted body weight), inspiratory to expiratory [I: E] ratio of 1:2.5, a positive end-expiratory pressure (PEEP) of 5 cm H2O, respiratory rate (R.R) will be adjusted to achieve an PaCO2 of 35-45 mm Hg, peak inspiratory pressures (Ppk) will be limited to 35 cm H2O and a low fresh gas flow (FGF) (<2 L/min) in a semi closed circuit system. Transesophageal echocardiography (TEE) will be inserted and the right ventricular function will be assessed with the measurements of EDV, ESV, RVEF, both maximal systolic and diastolic TAV at the tricuspid annulus at the RV free wall recorded from the apical 4-chamber views using pulsed wave Doppler tissue imaging. All operations will be performed by the same surgeons. Intraoperative hypoxemia will be defined as decrease in arterial oxygen saturation less than 90% will be treated with increasing of FiO2 to 1.0. Addition of low level of 2 cm H2O of CPAP will be considered if the later fails to correct hypoxemia. 1 Intraoperative fluid therapy will include intravenous infusion of 2 ml/kg/hour of Lactated Ringer's solution and blood losses will be compensated with colloids and with red blood cell concentrates if the hemoglobin levels decreases below 8 to 9 g/dL. Mean arterial blood pressure will be maintained greater than 60 mm Hg using bolus doses of ephedrine 5 mg or phenylephrine 100 ug. Urine output will be maintained to be greater than 0.5 ml/kg/hour. At the end of surgery, the nondependent will be re-expanded and TLV will be resumed as before surgery, sevoflurane will be discontinued, the residual neuromuscular block will be antagonized, and the patient will be extubated. Postoperative analgesia will be accomplished with the use of continuous epidural/paravertebral infusion of bupivacaine 0.125% and fentanyl 2 µg/mL. Statistical Analysis: Data will be tested for normality using the Kolmogorov-Smirnov test. Fisher exact test will be used for categorical data. Repeated two-way ANOVA and paired t-test will be used to study the changes in the primary and secondary endpoints during each intervention. The Wilcoxon 2 rank sum test will be used for the non-parametric values. We will avoid the carryover effect (persistence of the effect of the first intervention on the operative conditions into the second period) through the comparison of the effects of period (time effect) and the order of treatment using independent t-tests. Data will be expressed as mean ± SD, number (%), or median [range]. A value of P < 0.05 will be 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 Diseases
Keywords
Thoracic surgery, one lung ventilation, pressure-controlled ventilation, volume-controlled ventilation, right ventricular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The PCV-VCV group
Arm Type
Active Comparator
Arm Description
The dependent lung will be ventilated with pressure controlled (PCV) followed by the volume-controlled ventilation (VCV)
Arm Title
The VCV-PCV group
Arm Type
Active Comparator
Arm Description
The dependent lung will be ventilated with volume-controlled ventilation (VCV) followed by the pressure controlled (PCV)
Intervention Type
Other
Intervention Name(s)
The PCV-VCV group
Intervention Description
During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
Intervention Type
Other
Intervention Name(s)
The VCV-PCV group
Intervention Description
During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
Primary Outcome Measure Information:
Title
Right ventricular function
Description
Peak systolic and diastolic tricuspid annular velocity (TAV)
Time Frame
Change from baseline at 30 min after the initiation of the intervention
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure
Time Frame
Change from baseline at 30 min after the initiation of the intervention
Title
Pa/FiO2 ratio
Description
the ratio between arterial oxygen tension (PaO2)and inspired fraction of oxygen (FiO2)
Time Frame
Change from baseline at 30 min after the initiation of the intervention
Title
Airway pressures
Description
Peak and plateau airway pressures
Time Frame
Change from baseline at 30 min after the initiation of the intervention
Title
Right ventricular volumes
Description
right ventricular end diastolic and systolic volumes
Time Frame
Change from baseline at 30 min after the initiation of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical class from II to III Exclusion Criteria: decompensated cardiac (New York Heart Association >II) pulmonary (vital capacity or FEV1% < 50% of the predicted values) asthma hepatic diseases. renal diseases arrhythmias pulmonary hypertension (mean pulmonary artery pressure >30 mm Hg) body mass index >35 kg/m2 previous history of pneumonectomy, bilobectomy, or lobectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed R El Tahan, MD
Organizational Affiliation
Assistant Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roshdi Al Metwally, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hatem Qutub, MD
Organizational Affiliation
Associate Professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yasser F El Ghoneimy, MD
Organizational Affiliation
Associate Professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed A Regal, MD
Organizational Affiliation
Associate Professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haytham Zien, MD
Organizational Affiliation
Assistant Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Anesthesiology Department
City
Al Khubar
State/Province
Eastern
ZIP/Postal Code
31592
Country
Saudi Arabia

12. IPD Sharing Statement

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Pressure-controlled vs Volume Controlled Ventilation on RV Function During OLV

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