Lung Diseases Clinical Trial
Official title:
Right Ventricular Function During One-lung Ventilation: The Effects of Pressure Controlled and Volume Controlled Ventilation
Verified date | July 2013 |
Source | Dammam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Saudi Arabia: Ministry of Higher Education |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Anesthesiology Department | Al Khubar | Eastern |
Lead Sponsor | Collaborator |
---|---|
Dammam University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Right ventricular function | Peak systolic and diastolic tricuspid annular velocity (TAV) | Change from baseline at 30 min after the initiation of the intervention | Yes |
Secondary | Blood pressure | Blood pressure | Change from baseline at 30 min after the initiation of the intervention | Yes |
Secondary | Pa/FiO2 ratio | the ratio between arterial oxygen tension (PaO2)and inspired fraction of oxygen (FiO2) | Change from baseline at 30 min after the initiation of the intervention | Yes |
Secondary | Airway pressures | Peak and plateau airway pressures | Change from baseline at 30 min after the initiation of the intervention | Yes |
Secondary | Right ventricular volumes | right ventricular end diastolic and systolic volumes | Change from baseline at 30 min after the initiation of the intervention | Yes |
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