Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery
• Intervention / Treatment: Diagnostic test: auscultation by using electronic stethoscope in full PPE; Diagnostic test: auscultation by using conventional stethoscope without PPE

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Taiwan National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electronic auscultation	Diagnostic test: 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.
Conventional ausculatation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chun-Yu Wu, PhD, National Taiwan University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: endotracheal intubation; personal protective equipment; electronic stethoscope
• Other Study ID Numbers: 202005104RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No