Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT04873882

Conditions

Respiratory Sounds

Thoracic Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acoustic ventilation

Study Details

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

Study ID

NCT04873882

Start date

Dec 16, 2019

Status verified date

Apr, 2021

Completion date

Aug 27, 2021

Anticipated

Primary completion date

Aug 27, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Acoustic 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Allison J Bechtel, MD

434.924.2283as4sk@hscmail.mcc.virginia

Robert Thiele, MD

434.924.2283RHT7W@hscmail.mcc.virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Allison Bechtel, MD

434-924-2283as4sk@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 5, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2021-05-05.