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

NCT03523689 | Completed

• 2 other identifiers: 2018-0123NCI-2018-00964
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• New atelectasis for each segment

  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.

  Up to 3 years

• Atelectasis for each patient

  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.

  Up to 3 years

Secondary Outcomes (3)

• Common locations exhibiting atelectasis

  Up to 3 years

• Proportion of evaluated bronchial segments developing intraprocedural atelectasis

  Up to 3 years

• Patient characteristics associated with the presence of atelectasis

  Up to 3 years

Study Arms (1)

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; Procedure: Radial Probe Endobronchial Ultrasound

Interventions

Bronchoscopy PROCEDURE

Undergo bronchoscopy

Observational (bronchoscopy, RP-EBUS)

Radial Probe Endobronchial Ultrasound PROCEDURE

Undergo RP-EBUS

Also known as: Radial EBUS, Radial Endobronchial Ultrasound, Radial Probe EBUS, Radial-Probe Endobronchial Ultrasound, RP-EBUS

Observational (bronchoscopy, RP-EBUS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 32561439 DERIVED

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Roberto F Casal

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: April 30, 2018
• Primary Completion: October 26, 2020
• Study Completion: October 26, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)