Thoracic SurgeryNCT04507958
Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment
An observational study of Thoracic Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate the feasibility of auscultation to confirm the endotracheal tube position by using electronic stethoscope for clinicians who wear the full personal protective equipment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- auscultation by using conventional stethoscope without PPE and auscultation by using electronic stethoscope in full PPE
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2020to 11 May 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients meeting the eligibility criteria undergoing thoracic surgery in general anesthesia with endotracheal tube insertion and bronchial blocker will be assessed for informed consent
Who may be able to join
- Patients undergoing thoracic surgery in general anesthesia with endotracheal tube insertion and bronchial blocker.
Who cannot join
- Previous lung surgical history
- Patients with organs dysfunction, such as impaired liver function, eg. Aspartate Aminotransferase or Alanine Aminotransferase >100; liver cirrhosis > Child B class; impaired renal function, calculated glomerulus filtration rate< 60 ml/min/1.73 m2; cardiac dysfunction, such as heart failure > New York Heart Association class II, coronary arterial disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Electronic Stethoscope for Confirmation of Endotracheal Intubation Position in Full Personal Protective Equipment
To investigate the feasibility of auscultation to confirm the endotracheal tube position by using electronic stethoscope for clinicians who wear the full personal protective equipment.
Read the detailed description
After the pandemic outbreak of Coronavirus disease 2019 (COVID-19) in many countries, the number of critical ill patients are rapidly growing. Critical ill COVID-19 patients inevitably require endotracheal intubation for ventilator support. The chest X-rays, ultrasound, and stethoscope are three tools that can detect whether or not bronchial intubation has occurred. Auscultation by using the stethoscope is the routine first-line tool for this purpose. However, clinician who wears the full personal protective equipment (PPE) is very difficult to perform adequate auscultation with conventional stethoscope. In addition, the X-ray machines and ultrasound are very difficult to enter the negative-pressure isolation room and may raise the risks of infection spread. By using the electronic stethoscope amplified by the Bluetooth speaker, the clinician with full PPE may still hear the proper lung sound. In addition, electronic stethoscope has a good portability that can be easily brought into the isolation room. For patients undergoing surgery with general anesthesia, endotracheal tube is often mandatory and auscultation with stethoscope is routinely applied. Therefore, the investigators can simulate the circumstance that clinician with a full PPE to use the electronic stethoscope for confirmation of the proper endotracheal tube position. In addition, patients undergoing thoracic surgery require the single-lung ventilation which could be a proper simulation scenario for detection of bronchial intubation by using electronic stethoscope for clinicians with PPE.
- Conditions
- Thoracic Surgery
- Being tested
- auscultation by using conventional stethoscope without PPE, auscultation by using electronic stethoscope in full PPE
- Keywords
- endotracheal intubation, electronic stethoscope, personal protective equipment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auscultation by using conventional stethoscope without PPEDiagnostic test
In thoracic patients undergoing general anesthesia with endotracheal tube/endobronchial blocker, Clinician will check the position of endotracheal tube and endobronchial blocker under fiberscope. Afterward, investigator A will perform auscultation with traditional auscultation, then investigator B with electronic stethoscope under full PPE, to examine bilateral breathing sound.
auscultation by using electronic stethoscope in full PPEDiagnostic test
In thoracic patients undergoing general anesthesia with endotracheal tube/endobronchial blocker, Clinician will check the position of endotracheal tube and endobronchial blocker under fiberscope. Afterward, investigator A will perform auscultation with traditional auscultation, then investigator B with electronic stethoscope under full PPE, to examine bilateral breathing sound.
| Study group | Role | What they receive |
|---|---|---|
| Electronic auscultation | Not described Receives: Diagnostic Test: auscultation by using electronic stethoscope in full PPE | |
| Conventional ausculatation | Not described Receives: Diagnostic Test: auscultation by using conventional stethoscope without PPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to detect selective lung isolation states
Perform the auscultation by investigator A with traditional stethoscope, then by investigator B with electronic stethoscope under full PPE, to detect bronchial or tracheal intubation. The accuracy of successful detection (%) is the primary outcome.
Measured: 90 seconds
Secondary outcomes (1)
User experience of the electronic stethoscope
After complete of the trial, participant physicians will be asked to report the questionnaire of the experience of using electronic stethoscope.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start16 Sep 2020
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507958
- Sponsor's protocol ID
- 202005104RINC
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramsingh D, Frank E, Haughton R, Schilling J, Gimenez KM, Banh E, Rinehart J, Cannesson M. Auscultation versus Point-of-care Ultrasound to Determine Endotracheal versus Bronchial Intubation: A Diagnostic Accuracy Study. Anesthesiology. 2016 May;124(5):1012-20. doi: 10.1097/ALN.0000000000001073.
PubMed 26950708
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Electronic Stethoscope for Confirmation of Endotracheal Intubation Position in Full Personal Protective Equipment
- ClinicalTrials.gov ID
- NCT04507958
- Acronym / sponsor ID
- 202005104RINC
- Conditions
- Thoracic Surgery
- Keywords
- endotracheal intubation, electronic stethoscope, personal protective equipment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 11 Aug 2020 (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.
To investigate the feasibility of auscultation to confirm the endotracheal tube position by using electronic stethoscope for clinicians who wear the full personal protective equipment.
Detailed description
After the pandemic outbreak of Coronavirus disease 2019 (COVID-19) in many countries, the number of critical ill patients are rapidly growing. Critical ill COVID-19 patients inevitably require endotracheal intubation for ventilator support. The chest X-rays, ultrasound, and stethoscope are three tools that can detect whether or not bronchial intubation has occurred. Auscultation by using the stethoscope is the routine first-line tool for this purpose. However, clinician who wears the full personal protective equipment (PPE) is very difficult to perform adequate auscultation with conventional stethoscope. In addition, the X-ray machines and ultrasound are very difficult to enter the negative-pressure isolation room and may raise the risks of infection spread. By using the electronic stethoscope amplified by the Bluetooth speaker, the clinician with full PPE may still hear the proper lung sound. In addition, electronic stethoscope has a good portability that can be easily brought into the isolation room. For patients undergoing surgery with general anesthesia, endotracheal tube is often mandatory and auscultation with stethoscope is routinely applied. Therefore, the investigators can simulate the circumstance that clinician with a full PPE to use the electronic stethoscope for confirmation of the proper endotracheal tube position. In addition, patients undergoing thoracic surgery require the single-lung ventilation which could be a proper simulation scenario for detection of bronchial intubation by using electronic stethoscope for clinicians with PPE.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic auscultation | – | Diagnostic Test: auscultation by using electronic stethoscope in full PPE |
| Conventional ausculatation | – | Diagnostic Test: auscultation by using conventional stethoscope without PPE |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients meeting the eligibility criteria undergoing thoracic surgery in general anesthesia with endotracheal tube insertion and bronchial blocker will be assessed for informed consent
Key inclusion criteria (1 listed)
- Patients undergoing thoracic surgery in general anesthesia with endotracheal tube insertion and bronchial blocker.
Key exclusion criteria (2 listed)
- Previous lung surgical history
- Patients with organs dysfunction, such as impaired liver function, eg. Aspartate Aminotransferase or Alanine Aminotransferase >100; liver cirrhosis > Child B class; impaired renal function, calculated glomerulus filtration rate< 60 ml/min/1.73 m2; cardiac dysfunction, such as heart failure > New York Heart Association class II, coronary arterial disease
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 |
|---|---|---|
| auscultation by using conventional stethoscope without PPEIn thoracic patients undergoing general anesthesia with endotracheal tube/endobronchial blocker, Clinician will check the position of endotracheal tube and endobronchial blocker under fiberscope. Afterward, investigator A will perform auscultation with traditional auscultation, then investigator B with electronic stethoscope under full PPE, to examine bilateral breathing sound. | Diagnostic test | Conventional ausculatation |
| auscultation by using electronic stethoscope in full PPEIn thoracic patients undergoing general anesthesia with endotracheal tube/endobronchial blocker, Clinician will check the position of endotracheal tube and endobronchial blocker under fiberscope. Afterward, investigator A will perform auscultation with traditional auscultation, then investigator B with electronic stethoscope under full PPE, to examine bilateral breathing sound. | Diagnostic test | Electronic auscultation |
Primary outcome
The ability to detect selective lung isolation states
Time frame: 90 seconds
Perform the auscultation by investigator A with traditional stethoscope, then by investigator B with electronic stethoscope under full PPE, to detect bronchial or tracheal intubation. The accuracy of successful detection (%) is the primary outcome.
1 secondary outcome
User experience of the electronic stethoscope
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 26950708Ramsingh D, Frank E, Haughton R, Schilling J, Gimenez KM, Banh E, Rinehart J, Cannesson M. Auscultation versus Point-of-care Ultrasound to Determine Endotracheal versus Bronchial Intubation: A Diagnostic Accuracy Study. Anesthesiology. 2016 May;124(5):1012-20. doi: 10.1097/ALN.0000000000001073.
- 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.
Chun-Yu Wu, PhD principal investigator
National Taiwan University Hospital
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 Thoracic Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Jun 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to detect selective lung isolation states (time frame: 90 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507958, which also lists 1 linked publication.
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 8 Jun 2021.