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

Completed

• Conditions: Lung Neoplasm; Malignant Neoplasms of Respiratory and Intrathoracic Organs

• Registration Number: NCT03523689
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-14
• Primary Completion: 2020-10-26
• Study Completion: 2020-10-26
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States