Lung Neoplasm, Malignant Neoplasms of Respiratory and Intrathoracic Organs
Conditions
Keywords
Malignant neoplasms of respiratory and intrathoracic organs, Endobronchial ultrasound-guided transbronchial needle aspiration, EBUS-TBNA
Brief summary
This trial studies how well radial-probe endobronchial ultrasound works in detecting the complete or partial collapse of the lung in patients undergoing peripheral bronchoscopy. Diagnostic procedures, such as radial-probe endobronchial ultrasound and bronchoscopy, use a thin, tube-like instrument inserted through the nose or mouth to view and take pictures of the inside of the trachea, air passages, and lungs.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the proportion of patients identified as developing intraprocedural atelectasis detected by radial-probe endobronchial ultrasound (RP-EBUS) during peripheral bronchoscopy under general anesthesia. SECONDARY OBJECTIVES: I. To describe the most common locations for developing intraprocedural atelectasis detected by RP-EBUS. II. To describe the proportion of evaluated bronchial segments per patient that are identified as developing intraprocedural atelectasis by RP-EBUS. III. To identify patient and procedural characteristics that may predispose to the development of atelectasis. OUTLINE: Patients undergo bronchoscopy per standard of care, RP-EBUS of the left and right lungs during bronchoscopy procedure, and RP-imaging over 3-5 minutes at the end of the bronchoscopy procedure.
Interventions
PROCEDUREBronchoscopy
Undergo bronchoscopy
PROCEDURERadial Probe Endobronchial Ultrasound
Undergo RP-EBUS
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions * Recent computed tomography (CT) performed no more than 4 weeks prior to the bronchoscopy * Voluntary informed consent to participate in the study
Exclusion criteria
* Patients with baseline lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) in dependent areas of the lung as seen on most recent CT * Pregnancy * Ascites * Known diaphragmatic paralysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New atelectasis for each segment | Up to 3 years | Presence or absence of atelectasis within each of the aforementioned 8 segments will be determined using radial-probe endobronchial ultrasound (RP-EBUS) in comparison with the most recent computed tomography (CT) performed \< 4 weeks prior to the bronchoscopy. A segment will be identified as having a new atelectasis if there is an indication of solid- or semisolid-appearing lesion by RP-EBUS without a corresponding indication of solid tumor or atelectasis on the preoperative CT. Descriptive statistics (frequencies, proportions, means, standard deviations, and ranges) will be provided for patient characteristics. The proportion of patients identified as developing intraprocedural atelectasis by RP-EBUS and its 95% confidence interval will be estimated to accomplish the primary objective. |
| Atelectasis for each patient | Up to 3 years | Patients with at least 1 segment containing a new atelectasis will be determined to have atelectasis. Patients without atelectasis within any of the 8 segments will be determined to not have atelectasis. The proportion of patients identified as developing intraprocedural atelectasis by RP-EUS and its 95% confidence interval will be estimated to accomplish the primary objective. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Common locations exhibiting atelectasis | Up to 3 years | Locations of atelectasis will be summarized by a frequency table, allowing for multiple locations in the same patient. |
| Proportion of evaluated bronchial segments developing intraprocedural atelectasis | Up to 3 years | The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range. We will compare patients with atelectasis and patients without atelectasis in terms of patient characteristics using a t-test or Wilcoxon test for continuous variables and Fisher's exact test or chi-squared test for categorical variables. |
| Patient characteristics associated with the presence of atelectasis | Up to 3 years | To identify patient characteristics associated with the presence of atelectasis, logistic regression analysis will be used if the number of patients with atelectasis is at least 10. Due to a small sample size, multivariate logistic regression analysis may not be applied. A p-value of less than 0.05 will indicate statistical significance. |
Countries
United States
Outcome results
None listed