Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment

Thoracic Surgery Clinical Trial

Official title:

The Accuracy of Electronic Stethoscope for Confirmation of Endotracheal Intubation Position in Full Personal Protective Equipment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507958
• Other study ID #: 202005104RINC
• Status: Completed
• Start date: September 16, 2020
• Est. completion date: May 11, 2021

Study information

• Verified date: August 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing thoracic surgery in general anesthesia with endotracheal tube insertion and bronchial blocker.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Diagnostic Test:
• auscultation by using conventional stethoscope without PPE
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 PPE
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.

Locations

Country	Name	City	State
Taiwan	Taiwan National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 seconds
Secondary	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.	Through study completion, an average of 1 year