Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment

Completed

• Conditions: Thoracic Surgery
• Interventions: Diagnostic Test: auscultation by using conventional stethoscope without PPE; Diagnostic Test: auscultation by using electronic stethoscope in full PPE

• Registration Number: NCT04507958
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

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 Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-09-16
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional ausculatation	auscultation by using conventional stethoscope without PPE	-
Electronic auscultation	auscultation by using electronic stethoscope in full PPE	-

Primary Outcome Measures

Name	Time	Method
The ability to detect selective lung isolation states	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.

Secondary Outcome Measures

Name	Time	Method
User experience of the electronic stethoscope	Through study completion, an average of 1 year	After complete of the trial, participant physicians will be asked to report the questionnaire of the experience of using electronic stethoscope.

Trial Locations

Locations (1)

Taiwan National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan