Clinical trial NCT03523689: Radial-Probe Endobronchial Ultrasound in Detecting Atelectasis in Patients Undergoing Peripheral Bronchoscopy
Official title: Prevalence and Location of Intra-Procedural Atelectasis Detected by Radial-Probe Endobronchial Ultrasound During Peripheral Bronchoscopy Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasms of Respiratory and Intrathoracic Organs
Lung Neoplasm
Keywords: Malignant neoplasms of respiratory and intrathoracic organs
Endobronchial ultrasound-guided transbronchial needle aspiration
EBUS-TBNA
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions

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.

Eligibility 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

Primary outcomes:
measure: New atelectasis for each segment
timeFrame: Up to 3 years
measure: Atelectasis for each patient
timeFrame: Up to 3 years
Secondary outcomes:
measure: Common locations exhibiting atelectasis
timeFrame: Up to 3 years
measure: Proportion of evaluated bronchial segments developing intraprocedural atelectasis
timeFrame: Up to 3 years
measure: Patient characteristics associated with the presence of atelectasis
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Roberto F Casal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sagar AS, Sabath BF, Eapen GA, Song J, Marcoux M, Sarkiss M, Arain MH, Grosu HB, Ost DE, Jimenez CA, Casal RF. Incidence and Location of Atelectasis Developed During Bronchoscopy Under General Anesthesia: The I-LOCATE Trial. Chest. 2020 Dec;158(6):2658-2666. doi: 10.1016/j.chest.2020.05.565. Epub 2020 Jun 17.