Respiratory SoundsNCT04873882
Waveform and Spectral Characteristics of Perioperative Wheezing
An observational study of Respiratory Sounds and Thoracic Surgery, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Sounds, Thoracic Surgery
- What is being tested?
- Acoustic ventilation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 27 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- Emergency surgery
- surgery requiring the use of transesophageal echocardiography
- refusal of informed consent
- pregnancy
- esophageal surgery
- lung transplantation
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Allison Bechtel, MD, 434-924-2283, as4sk@virginia.edu
About this study
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.
Read the 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.
- Conditions
- Respiratory Sounds, Thoracic Surgery
- Being tested
- Acoustic ventilation
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic ventilationDevice
- Placement and removal of the esophageal stethoscope
- 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."
- 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.
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Duration of the operation while the esophageal stethoscope is in place, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start16 Dec 2019
- Primary completion27 Aug 2021 (estimated)
- Study completion27 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory SoundsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Bechtel, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873882
- Sponsor's protocol ID
- 21550
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waveform and Spectral Characteristics of Perioperative Wheezing
- ClinicalTrials.gov ID
- NCT04873882
- Acronym / sponsor ID
- 21550
- Conditions
- Respiratory Sounds, Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 27 Aug 2021 (estimated)
- Study completion
- 27 Aug 2021 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- Emergency surgery
- surgery requiring the use of transesophageal echocardiography
- refusal of informed consent
- pregnancy
- esophageal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic ventilation1. 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. | Device | – |
Primary outcome
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
Comparison of the spectral waveforms to determine the specific frequency bands associated with wheezing and non-wheezing
1 secondary outcome
Spectral waveform analysis associated with ventilatory parameters
Time frame: Duration of the operation while the esophageal stethoscope is in place, an average of 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Sounds and Thoracic Surgery, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allison J Bechtel, MD (434.924.2283, as4sk@hscmail.mcc.virginia), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.