Skip to main content
OpenTrials
Completed

NCT Number: NCT03523689

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Neoplasms of Respiratory and Intrathoracic Organs Lung Diseases Lung Neoplasm Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Procedure

Undergo bronchoscopy

Radial Probe Endobronchial Ultrasound

Procedure

Undergo RP-EBUS

Other names: Radial EBUS, Radial Endobronchial Ultrasound, Radial Probe EBUS, Radial-Probe Endobronchial Ultrasound, RP-EBUS

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Prevalence and Location of Intra-Procedural Atelectasis Detected by Radial-Probe Endobronchial Ultrasound During Peripheral Bronchoscopy Under General Anesthesia

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 14, 2018
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.