Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring

Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring - Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023605

Enrollment

Registered

2016-09-01

Start date

2016-08-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers of ASA-PS (American Society of Anesthesiolosists-Physical Status)1 or 2

Exclusion criteria

Exclusion criteria: (1) Volunteers of >ASA-PS 3 (2)A minor

Design outcomes

Primary

Measure	Time frame
Each volunteer quietly lied down a bed in a quiet separated room An adhesive sensor integrated acoustic transducer was attached to his or her neck and pulse oximeter was attached on the right index finger. The aforementioned sensors were connected to the RRa monitoring system, and an observer confirmed the steady respiratory signal on the display of the RRa monitor for ten minutes. At the same time, another observer checked respiratory rate counting chest wall movements. A supervisor confirmed the each data of respiratory rate from RRa and counting chest wall movements at each occasion. The volunteer breathed at randomly indicated respiratory rate of 6, 12 and 30/min according to modified Early Warning Score. The volunteer maintained the constant breathing rhythm by referring to a second hand of a clock. Sound level was measured with an accurate sound level meter, and ambient sound level of the room under no audible sound was 45-55 dB. The noise around the neck sensor was generated by a forced-air warming system and the noise level was changed by following four steps of adjusting the distance between the nozzle of a forced-air warming system and the neck sensor; 45-55dB (no sound); 56-65dB (35-50 cm); 66-75dB (20-35 cm); and 76-85dB(10-20 cm). Thus, all volunteers performed 12 settings, including 3 patterns of respiratory rate and 4 sound levels. In each setting, respiratory rate was measured by an observer manually counting chest wall movements and RRa by another observer and repeated consecutive 3 min. Mean respiratory rate for the 3 min by the manual counting and RRa was recorded. RRa over 20% of the indicated respiratory rate for 15 sec or more was considered incorrect value and the other was considered correct value.	—

Measure

Time frame

Each volunteer quietly lied down a bed in a quiet separated room An adhesive sensor integrated acoustic transducer was attached to his or her neck and pulse oximeter was attached on the right index finger. The aforementioned sensors were connected to the RRa monitoring system, and an observer confirmed the steady respiratory signal on the display of the RRa monitor for ten minutes. At the same time, another observer checked respiratory rate counting chest wall movements. A supervisor confirmed the each data of respiratory rate from RRa and counting chest wall movements at each occasion. The volunteer breathed at randomly indicated respiratory rate of 6, 12 and 30/min according to modified Early Warning Score. The volunteer maintained the constant breathing rhythm by referring to a second hand of a clock. Sound level was measured with an accurate sound level meter, and ambient sound level of the room under no audible sound was 45-55 dB. The noise around the neck sensor was generated by a forced-air warming system and the noise level was changed by following four steps of adjusting the distance between the nozzle of a forced-air warming system and the neck sensor; 45-55dB (no sound); 56-65dB (35-50 cm); 66-75dB (20-35 cm); and 76-85dB(10-20 cm). Thus, all volunteers performed 12 settings, including 3 patterns of respiratory rate and 4 sound levels. In each setting, respiratory rate was measured by an observer manually counting chest wall movements and RRa by another observer and repeated consecutive 3 min. Mean respiratory rate for the 3 min by the manual counting and RRa was recorded. RRa over 20% of the indicated respiratory rate for 15 sec or more was considered incorrect value and the other was considered correct value.

—

Countries

Japan

Contacts

Public ContactShizuha Yabuki

Tohoku University Hospital Department of Anesthesiology

yabuki-thk@umin.ac.jp+81-22-717-7321

Outcome results