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Radial-Probe Endobronchial Ultrasound in Detecting Atelectasis in Patients Undergoing Peripheral Bronchoscopy

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ClinicalTrials.gov Identifier: NCT03523689
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Malignant Neoplasms of Respiratory and Intrathoracic Organs Lung Neoplasm Procedure: Bronchoscopy Procedure: Radial Probe Endobronchial Ultrasound

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.

Study Design
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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Procedure: Bronchoscopy
Undergo bronchoscopy

Procedure: Radial Probe Endobronchial Ultrasound
Undergo RP-EBUS
Other Names:
  • Radial EBUS
  • Radial Endobronchial Ultrasound
  • Radial Probe EBUS
  • Radial-Probe Endobronchial Ultrasound
  • RP-EBUS


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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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
Study Population
Adult patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Roberto F. Casal, MD 713-792-6238 rfcasal@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Roberto F. Casal    713-792-6238      
Principal Investigator: Roberto F. Casal         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Roberto F Casal M.D. Anderson Cancer Center
More Information
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Additional Information:

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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 )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of respiratory and intrathoracic organs
Endobronchial ultrasound-guided transbronchial needle aspiration
EBUS-TBNA
Additional relevant MeSH terms:
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Lung Neoplasms
Pulmonary Atelectasis
Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases