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Waveform and Spectral Characteristics of Perioperative Wheezing

Waveform and Spectral Characteristics of Perioperative Wheezing

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04873882
Enrollment
40
Registered
2021-05-05
Start date
2019-12-16
Completion date
2021-08-27
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Sounds, Thoracic Surgery

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.

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.

Interventions

DEVICEAcoustic ventilation

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.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Spectral Waveform Analysis to discriminate between wheezing and not wheezing based on specific frequency bandsDuration of the operation while the esophageal stethoscope is in place, an average of 3 hoursComparison of the spectral waveforms to determine the specific frequency bands associated with wheezing and non-wheezing

Secondary

MeasureTime frameDescription
Spectral waveform analysis associated with ventilatory parametersDuration of the operation while the esophageal stethoscope is in place, an average of 3 hoursVentilatory 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

Countries

United States

Contacts

Primary ContactAllison J Bechtel, MD
as4sk@hscmail.mcc.virginia434.924.2283
Backup ContactRobert Thiele, MD
RHT7W@hscmail.mcc.virginia.edu434.924.2283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026