Waveform and Spectral Characteristics of Perioperative Wheezing

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Sounds; Thoracic Surgery
• Intervention / Treatment: Device: Acoustic ventilation

Detailed Description

Anesthesiologists still rely on use of a conventional stethoscope to detect abnormal breath sounds during and after surgery - this process is labor intensive, intermittent, relies on human experience and thus is highly subjective. In fact, even for the most basic assessments, e.g. endobronchial intubation, human auscultation is unreliable.1 Digital stethoscopes are able to both amplify and digitize airway sounds and also provide a mechanism to record and analyze them for features undetectable by a human. Several small, pilot studies have shown that acoustic waveforms from the lungs produce characteristic spectral patterns in specific pulmonary pathophysiologic states. At this time, there are no studies that examine the acoustic patterns specific to perioperative wheezing or lung re-expansion. 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 and monitoring 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. In addition, treatment of perioperative wheezing with an inhaled bronchodilator may lead to resolution of wheezing and this response to treatment may also be monitored using waveform and spectral characteristics of the acoustic patterns from the digital stethoscope.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Allison J Bechtel, MD; Phone Number: 434.924.2283; Email: as4sk@hscmail.mcc.virginia
• Study Contact Backup: Name: Robert Thiele, MD; Phone Number: 434.924.2283; Email: RHT7W@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Allison Bechtel, MD; Phone Number: 434-924-2283; Email: as4sk@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

Inclusion Criteria:

Patients scheduled for either:

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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectral waveform analysis associated with ventilatory parameters	Ventilatory parameters including respiratory rate, tidal volume, and airway pressures that were recorded during the case will be compared with the spectral waveforms to determine the specific frequency bands associated with ventilatory parameters during one-lung ventilation and two-lung ventilation	Duration of the operation while the esophageal stethoscope is in place, an average of 3 hours

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Anticipated): August 27, 2021
• Study Completion (Anticipated): August 27, 2021

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: 21550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No