UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

RRa utilizes acoustic technology to detect vibratory sounds originating in the walls of the large airways during breathing and transforms the sounds into an electrical signal that is converted into a numerical measurement that corresponds to a respiratory rate. Accuracy and precision of RRa was already reported. However, phonation or large sound around the sensor causes to display improper value respiratory rate. No previous report has investigated the threshold minimum of environmental noise level, which impedes accurate RRa monitoring. The purpose of this study is to evaluate the influence of environmental noise generated by forced-air warming system, which is widely used in operating rooms and intensive care unit, to respiratory rate monitoring by RRa in healthy volunteers.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study is to evaluate the influence of environmental noise generated by forced-air warming system, which is widely used in operating rooms and intensive care unit, to respiratory rate monitoring by RRa in healthy volunteers.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Hiroaki Toyama

Organization

Tohoku University Hospital

Division name

Department of Anesthesiology

Zip code

Address

Department of Anesthesiology, Tohoku University Hospital, 1-1 Seiryomachi, Aoba-ku, Sendai

TEL

+81-22-717-7321

Email

h-toyama@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Shizuha Yabuki

Organization

Tohoku University Hospital

Division name

Department of Anesthesiology

Zip code

Address

Department of Anesthesiology, Tohoku University Hospital, 1-1 Seiryomachi, Aoba-ku, Sendai

TEL

+81-22-717-7321

Homepage URL

Email

yabuki-thk@umin.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

07

Month

31

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

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.

Registered date

2016

Year

08

Month

12

Day

Last modified on

2016

Year

08

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026890