UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring
Title of the study (Brief title)	Evaluation of the influence of environmental sound level and respiratory rate to accuracy of acoustic respiratory rate monitoring
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Hiroaki Toyama
Organization	Tohoku University Hospital
Division name	Department of Anesthesiology
Address	Department of Anesthesiology, Tohoku University Hospital, 1-1 Seiryomachi, Aoba-ku, Sendai
TEL	+81-22-717-7321
Email	h-toyama@umin.ac.jp

Public contact
Name of contact person	Shizuha Yabuki
Organization	Tohoku University Hospital
Division name	Department of Anesthesiology
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

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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.

Management information
Registered date	2016 Year 08 Month 12 Day
Last modified on	2016 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026890