SBIR-STTR Award

Bedside Monitoring Of Endotracheal Tube Position
Award last edited on: 9/20/13

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$402,986
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Hussein A Mansy

Company Information

Biomedical Acoustics Research Company (AKA: BARC)

4079 Conway Place Circle
Orlando, FL 32812
Location: Single
Congr. District: 09
County: Orange

Phase I

Contract Number: 1R43HL112374-01A1
Start Date: 8/15/12    Completed: 7/31/14
Phase I year
2012
Phase I Amount
$266,543
The objective of this project is to develop an innovative, accurate, and low-cost technology for bedside continuous (vs. intermittent) monitoring of endotracheal tube (ETT) positioning. The new ETT malposition detector (ET-MD) uses automated analysis of breath sounds and will be able to detect bronchial intubation and extubation (tube slippage into the bronchus or out of the trachea, respectively). Broncheal intubation may occur due to tube manipulation or patient movement and may lead to significant hypoxia and atelectasis (and possibly barotrauma and pneumothorax of the ventilated lung). Although extubation may become clinically apparent after some time, instant recognition can help avoid hypoxia. The ET-MD operation exploits the physics principle of the dependence of breath sounds on lung ventilation. There are two essential ET-MD components: 1) Acoustic sensors and 2) Computational and display module that analyzes acoustic signals and reports relevant metrics indicative of ETT location. We propose to construct and test a prototype under likely use conditions. Here, effects of room noise, adventitious sounds, and sensor positioning errors will be investigated in animals. In addition, the device will be tested in human subjects with and without pulmonary conditions and obesity. Key words: (8 maximum) Acoustics, endotracheal tube, intubation, malpositioning, breath sounds, diagnosis.

Public Health Relevance:
This project proposes to develop a device to help improve monitoring of endotracheal tubes used in patients with ventilatory failure, airway compromise, and/or during general anesthesia. It will alert health care providers to tube malposition. This wil likely allow improved early correction of tube position, which would result in reduced morbidity, mortality and cost of healthcare.

Public Health Relevance Statement:
This project proposes to develop a device to help improve monitoring of endotracheal tubes used in patients with ventilatory failure, airway compromise, and/or during general anesthesia. It will alert health care providers to tube malposition. This wil likely allow improved early correction of tube position, which would result in reduced morbidity, mortality and cost of healthcare.

NIH Spending Category:
Bioengineering; Clinical Research; Lung

Project Terms:
Acoustics; Animals; Atelectasis; Bedside Technology; Breath Tests; Bronchi; Bronchoscopy; Characteristics; Chest; Computer software; computerized data processing; Computers; cost; Custom; Dependence; design and construction; detector; Devices; Diagnosis; Diagnostic; Dimensions; Dysbarism; endotracheal; Environmental air flow; Failure (biologic function); Family suidae; General Anesthesia; Generations; Gold; Health Care Costs; Health Personnel; Human; human subject; Hypoxia; improved; Individual; information display; innovation; Intubation; Lead; Location; Lung; Lung diseases; meetings; Metric; Modeling; Monitor; Morbidity - disease rate; Mortality Vital Statistics; Movement; Neck; Noise; Obesity; operation; Oropharyngeal; Patients; Performance; Phase; Physics; Pneumothorax; Positioning Attribute; Process; prototype; Pulmonary Pathology; Reporting; Research; Respiratory System; sensor; Signal Transduction; sound; Technology; Testing; Time; Trachea; Tube; Weight

Phase II

Contract Number: 5R43HL112374-02
Start Date: 8/15/12    Completed: 7/31/14
Phase II year
2013
Phase II Amount
$136,443
The objective of this project is to develop an innovative, accurate, and low-cost technology for bedside continuous (vs. intermittent) monitoring of endotracheal tube (ETT) positioning. The new ETT malposition detector (ET-MD) uses automated analysis of breath sounds and will be able to detect bronchial intubation and extubation (tube slippage into the bronchus or out of the trachea, respectively). Broncheal intubation may occur due to tube manipulation or patient movement and may lead to significant hypoxia and atelectasis (and possibly barotrauma and pneumothorax of the ventilated lung). Although extubation may become clinically apparent after some time, instant recognition can help avoid hypoxia. The ET-MD operation exploits the physics principle of the dependence of breath sounds on lung ventilation. There are two essential ET-MD components: 1) Acoustic sensors and 2) Computational and display module that analyzes acoustic signals and reports relevant metrics indicative of ETT location. We propose to construct and test a prototype under likely use conditions. Here, effects of room noise, adventitious sounds, and sensor positioning errors will be investigated in animals. In addition, the device will be tested in human subjects with and without pulmonary conditions and obesity. Key words: (8 maximum) Acoustics, endotracheal tube, intubation, malpositioning, breath sounds, diagnosis.

Public Health Relevance Statement:
This project proposes to develop a device to help improve monitoring of endotracheal tubes used in patients with ventilatory failure, airway compromise, and/or during general anesthesia. It will alert health care providers to tube malposition. This wil likely allow improved early correction of tube position, which would result in reduced morbidity, mortality and cost of healthcare.

Project Terms:
Acoustics; Animals; Atelectasis; Bedside Technology; Breath Tests; Bronchi; Bronchoscopy; Characteristics; Chest; Computer software; computerized data processing; Computers; cost; Custom; Dependence; design and construction; detector; Devices; Diagnosis; Diagnostic; Dimensions; Dysbarism; endotracheal; Environmental air flow; Failure (biologic function); Family suidae; General Anesthesia; Generations; Gold; Health Care Costs; Health Personnel; Human; human subject; Hypoxia; improved; Individual; information display; innovation; Intubation; Lead; Location; Lung; Lung diseases; meetings; Metric; Modeling; Monitor; Morbidity - disease rate; Mortality Vital Statistics; Movement; Neck; Noise; Obesity; operation; Oropharyngeal; Patients; Performance; Phase; Physics; Pneumothorax; Positioning Attribute; Process; prototype; Pulmonary Pathology; Reporting; Research; Respiratory System; sensor; Signal Transduction; sound; Technology; Testing; Time; Trachea; Tube; Weight