Clinical trial NCT04507958: Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment
Official title: The Accuracy of Electronic Stethoscope for Confirmation of Endotracheal Intubation Position in Full Personal Protective Equipment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Keywords: endotracheal intubation
electronic stethoscope
personal protective equipment
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The ability to detect selective lung isolation states
timeFrame: 90 seconds
Secondary outcomes:
measure: User experience of the electronic stethoscope
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taiwan National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.