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Completed

NCT Number: NCT04507958

Electronic Stethoscope Use During Intubation 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.

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Key information

Conditions

Thoracic Surgery

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taiwan National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

auscultation by using conventional stethoscope without PPE

Diagnostic 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 PPE

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. User experience of the electronic stethoscope

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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