Waveform and Spectral Characteristics of Perioperative Wheezing

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04873882
Collaborator
(none)
40
1
20.4
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Waveform and Spectral Characteristics of Perioperative Wheezing
Actual Study Start Date :
Dec 16, 2019
Anticipated Primary Completion Date :
Aug 27, 2021
Anticipated Study Completion Date :
Aug 27, 2021

Outcome Measures

Primary Outcome Measures

  1. Spectral Waveform Analysis to discriminate between wheezing and not wheezing based on specific frequency bands [Duration of the operation while the esophageal stethoscope is in place, an average of 3 hours]

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

Secondary Outcome Measures

  1. Spectral waveform analysis associated with ventilatory parameters [Duration of the operation while the esophageal stethoscope is in place, an average of 3 hours]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Charlottesville Virginia United States 22908

Sponsors and Collaborators

  • University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Allison Bechtel, MD, Assistant Professor of Anesthesiology, University of Virginia
ClinicalTrials.gov Identifier:
NCT04873882
Other Study ID Numbers:
  • 21550
First Posted:
May 5, 2021
Last Update Posted:
May 5, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2021