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

NCT ID: NCT03523689

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-30

Study Completion Date

2020-10-26

Brief Summary

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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

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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.

Conditions

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Malignant Neoplasms of Respiratory and Intrathoracic Organs Lung Neoplasm

Keywords

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Malignant neoplasms of respiratory and intrathoracic organs Endobronchial ultrasound-guided transbronchial needle aspiration EBUS-TBNA

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bronchoscopy

Intervention Type PROCEDURE

Undergo bronchoscopy

Radial Probe Endobronchial Ultrasound

Intervention Type PROCEDURE

Undergo RP-EBUS

Interventions

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Bronchoscopy

Undergo bronchoscopy

Intervention Type PROCEDURE

Radial Probe Endobronchial Ultrasound

Undergo RP-EBUS

Intervention Type PROCEDURE

Other Intervention Names

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Radial EBUS Radial Endobronchial Ultrasound Radial Probe EBUS Radial-Probe Endobronchial Ultrasound RP-EBUS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto F Casal

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32561439 (View on PubMed)

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2018-00964

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0123

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0123

Identifier Type: -

Identifier Source: org_study_id