Waveform and Spectral Characteristics of Perioperative Wheezing

NCT04873882 | Unknown FDA Device

• 1 other identifier: 21550
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

With the aid of computerized sound analysis, digital acoustic monitoring could provide a more sensitive, specific, and quantifiable indicator for perioperative respiratory abnormalities including wheezing. It is probable that the digital stethoscope has utility in the detection, monitoring, and resolution following treatment of acoustic changes characteristic of turbulent respiratory gas flow due to wheezing and/or the incomplete resolution of atelectasis following the re-initiation of ventilation in a collapsed lung.

Conditions

Respiratory Sounds; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Spectral Waveform Analysis to discriminate between wheezing and not wheezing based on specific frequency bands

  Comparison of the spectral waveforms to determine the specific frequency bands associated with wheezing and non-wheezing

  Duration of the operation while the esophageal stethoscope is in place, an average of 3 hours

Secondary Outcomes (1)

• Spectral waveform analysis associated with ventilatory parameters

  Duration of the operation while the esophageal stethoscope is in place, an average of 3 hours

Interventions

Acoustic ventilation DEVICE

1. Placement and removal of the esophageal stethoscope 2. Connection of a microphone to the esophageal stethoscope outside of and removed from the patient's body at the location on the figure above "Connection fo monaural earpiece." 3. Digital breath sound real-time monitoring will be collected as .wav files from the device with no identifiable elements and the data from the device will be downloaded onto a desktop and we will keep and store the data on a secure departmental server. 4. Additional monitoring schedule includes evaluation of breath sounds with a conventional stethoscope every 30 minutes intraoperatively, at the start of one-lung ventilation, at the return to two-lung ventilation and prior to extubation and during any changes on the digital breath sounds recording monitor.

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

Patients undergoing the following procedures: 1. open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring one-lung ventilation 2. abdominal surgery with a known history of chronic obstructive pulmonary disease (as documented in the electronic medical record)

You may qualify if:

• Patients scheduled for either:
• open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring one-lung ventilation
• abdominal surgery with a known history of chronic obstructive pulmonary disease (as documented in the electronic medical record)

You may not qualify if:

• Emergency surgery
• surgery requiring the use of transesophageal echocardiography
• refusal of informed consent
• pregnancy
• esophageal surgery
• lung transplantation
• contraindications for placement of esophageal stethoscope including esophageal varices strictures, motility disorders, diverticula or a history of prior esophageal injury or surgery
• age less than 18 years old
• prisoner

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Allison J Bechtel, MD

CONTACT

434.924.2283; as4sk@hscmail.mcc.virginia

Robert Thiele, MD

CONTACT

434.924.2283; RHT7W@hscmail.mcc.virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 5, 2021
• Study Start: December 16, 2019
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)