Radial-Probe Endobronchial Ultrasound in Detecting Atelectasis in Patients Undergoing Peripheral Bronchoscopy
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ClinicalTrials.gov Identifier: NCT03523689 |
Recruitment Status :
Completed
First Posted : May 14, 2018
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment |
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Malignant Neoplasms of Respiratory and Intrathoracic Organs Lung Neoplasm | Procedure: Bronchoscopy Procedure: Radial Probe Endobronchial Ultrasound |
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.
Study Type : | Observational |
Actual Enrollment : | 57 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Prevalence and Location of Intra-Procedural Atelectasis Detected by Radial-Probe Endobronchial Ultrasound During Peripheral Bronchoscopy Under General Anesthesia |
Actual Study Start Date : | April 30, 2018 |
Actual Primary Completion Date : | October 26, 2020 |
Actual Study Completion Date : | October 26, 2020 |

Group/Cohort | Intervention/treatment |
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Observational (bronchoscopy, RP-EBUS)
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.
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Procedure: Bronchoscopy
Undergo bronchoscopy Procedure: Radial Probe Endobronchial Ultrasound Undergo RP-EBUS
Other Names:
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- New atelectasis for each segment [ Time Frame: 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 [ Time Frame: 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.
- Common locations exhibiting atelectasis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523689
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Roberto F Casal | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT03523689 |
Other Study ID Numbers: |
2018-0123 NCI-2018-00964 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0123 ( Other Identifier: M D Anderson Cancer Center ) |
First Posted: | May 14, 2018 Key Record Dates |
Last Update Posted: | November 13, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Malignant neoplasms of respiratory and intrathoracic organs Endobronchial ultrasound-guided transbronchial needle aspiration EBUS-TBNA |
Neoplasms Lung Neoplasms Pulmonary Atelectasis Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |