Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment

NCT04507958 | Completed

• 1 other identifier: 202005104RINC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery

Keywords

endotracheal intubation; electronic stethoscope; personal protective equipment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• User experience of the electronic stethoscope

  Through study completion, an average of 1 year

Study Arms (2)

Electronic auscultation

Diagnostic Test: auscultation by using electronic stethoscope in full PPE

Conventional ausculatation

Diagnostic Test: auscultation by using conventional stethoscope without PPE

Interventions

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.

Conventional ausculatation

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.

Electronic auscultation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Taiwan National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related 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.

  PMID: 26950708 BACKGROUND

Study Officials

• Chun-Yu Wu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: September 16, 2020
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: June 8, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)