Lung Diseases Clinical Trial
Official title:
Effects of Different Tidal Volumes on Extravascular Lung Water Content During One-lung Ventilation for Video-assisted Thoracoscopic Surgery: Dammam University Experience
Verified date | July 2013 |
Source | Dammam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Saudi Arabia: University of Dammam |
Study type | Interventional |
The use of low tidal volume (TV) during one lung ventilation (OLV) for thoracic surgery decreases the incidence of postoperative acute lung injury (ALI). We postulated that the use of low TV during OLV for video-assisted thoracoscopic surgery (VATS) would decrease the extravascular lung water content index (EVLWI). After local ethics committee approval and informed consent, we will randomly allocate 60 patients scheduled for elective VATS to ventilate the dependent lung with VT of 4, 6, or 8 mL/kg (n= 20 for each), I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain normocapnia. Perioperative changes in EVLWI, hemodynamics, oxygenation index will be recorded. Also, the incidence of postoperative ALI, morbidity, hospitalization and mortality will be recorded
Status | Completed |
Enrollment | 39 |
Est. completion date | February 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiologists physical classes from II to III Exclusion Criteria: - decompensated cardiac diseases - pulmonary diseases - hepatic diseases - renal diseases - pulmonary hypertension - obesity with a body mass index >35 kg/m2 - preoperative mechanically ventilated - urgent procedures - previous history of pneumonectomy, bilobectomy, or lobectomy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, 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 | Extra vascular lung water (EVLW) | extra vascular lung water (EVLW) | Change from baseline up to 3 hours after surgery. | Yes |
Secondary | Arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio | Arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio | Change from baseline up to 3 hours after surgery. | Yes |
Secondary | Arterial carbon dioxide tension (PaCO2) | Arterial carbon dioxide tension (PaCO2) | Change from baseline up to 3 hours after surgery. | Yes |
Secondary | Postoperative complications | pulmonary complications | Change from baseline up to 3 hours after surgery. | Yes |
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