Spontaneous Pneumothorax Clinical Trial
Official title:
Lung Deflation With Arndt® Blocker During Video-Assisted Thoracoscopy: A Comparison of the Disconnection Technique With a Continuous Bronchial Suction
Verified date | April 2015 |
Source | Dammam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Saudi Arabia: Ministry of Higher Education |
Study type | Interventional |
The use of wire-guided Arndt® endobronchial blocker does not gain widespread acceptance
during video-assisted thoracoscopy (VATS) because it takes longer time to collapse the
operative lung especially in patients with chronic obstructive lung disease (COPD). The use
of a disconnection technique for deflation of Arndt® blocker had a comparable degree of lung
collapse with the use of double-lumen tubes. However, it carries a risk of blood or infected
secretions contaminating the dependent lung.
We hypothesise that the use bronchial suction of through a barrel part of a 1-mL insulin
syringe attached to the suction port of the bronchial blocker would be associated with
comparable time to optimum lung collapse with the disconnection technique.
After ethical approval, 58 patients with spontaneous pneumothorax scheduled for elective
VATS using Arndt blocker® for lung separation will be included in this prospective,
randomized, double-blind study.
Patients will be randomly assigned to deflate the blocker with either disconnecting the
endotracheal tube from the ventilator for 60 s. prior to inflation of the bronchial blocker
allowing both lungs to collapse, or attaching -20 cm H2O of suction to the suction port of
the blocker through the barrel part of a 1-mL insulin syringe (n = 29 for each group).
Status | Completed |
Enrollment | 58 |
Est. completion date | April 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiologists physical class (II-III) - Need of one lung ventilation Exclusion Criteria: - New York Heart Association class> II. - Forced vital capacity (FVC) or forced expiratory volume in 1 second (FEV1) (< 50% of the predicted values). - Severe asthma. - Pregnancy. - Body mass index >35 kg/m2. - Anticipated difficult intubation. - Patients requiring absolute lung separation. - Known lesions along the path of the bronchial blockers. - Need preoperative ventilatory support. - Post-thoracic surgery pneumothorax. - Traumatic pneumothorax. - Emergency surgery. - History of lung resection. - Calculated ipsilateral percentage pneumothorax size exceeded 20% as estimated by helical CT-derived Collins'formula |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Dammam University | Al Khubar | Eastern |
Lead Sponsor | Collaborator |
---|---|
Dammam University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time needed for lung collapse | measured from the institution of OLV to the time of total lung collapse | 3 min before one lung ventilation | Yes |
Secondary | quality of lung collapse | The quality of lung collapse at 20 min intervals after one lung ventilation initiation according to a four-point ordinal scale,3, 8 ranging from 1 (extremely poor) to 4 (excellent). Extremely poor (Score 1) indicated no collapse; poor (Score 2) indicated that there is a partial collapse with interference with surgical exposure; good (Score 3) indicated that there is total collapse, but the lung still had residual air; and excellent (Score 4) indicated a complete collapse with perfect surgical exposure. The feasibility of this scale was investigated during six surgical procedures not included in the study. | every 20 min intervals after one lung ventilation initiation | No |
Secondary | Overall surgeon satisfaction | Overall surgeon satisfaction with surgical conditions as assessed using a verbal analog scale (0 = unsatisfied to 10 = very satisfied) | 15 min after surgery | No |
Secondary | Number of times that the fiberoptic bronchoscope required to assure proper position | The number of times that the FOB was required to assure proper position or to perform further bronchial suction | 5 min after reinflation of the surgical lung | No |
Secondary | Intraoperative hypoxemia | Intraoperative hypoxemia (SaO2 < 92%) | For 2 hours during surgery | No |
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