Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients

Alba Ramírez-Sarmiento,1– 3 Orlando Aya,3,4 Diana Cáceres-Rivera,1,2 Carlos F Reyes,2– 4 Angela Espitia,1,2 Camilo Pizarro,3,4 Joaquim Gea,5,6 Victor R Castillo,7,8 Mauricio Orozco-Levi1– 3,6 1Respiratory Department, Instituto Cardiovascular y Hospital Internacional de Colombia, Fundación Cardiovasc...

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Autores principales:	Ramírez-Sarmiento A, Aya O, Cáceres-Rivera D, Reyes CF, Espitia A, Pizarro C, Gea J, Castillo VR, Orozco-Levi M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	mechanical ventilation bronchoaspiration supraglottic suction supratube endotracheal tube gastroesophageal reflux. Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/60d37fcace1a4349a979e66ec43c87eb
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spelling	oai:doaj.org-article:60d37fcace1a4349a979e66ec43c87eb2021-12-02T18:55:09ZInvention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients1179-1470https://doaj.org/article/60d37fcace1a4349a979e66ec43c87eb2021-10-01T00:00:00Zhttps://www.dovepress.com/invention-and-pilot-study-of-the-efficacy-and-safety-of-the-supratube--peer-reviewed-fulltext-article-MDERhttps://doaj.org/toc/1179-1470Alba Ramírez-Sarmiento,1– 3 Orlando Aya,3,4 Diana Cáceres-Rivera,1,2 Carlos F Reyes,2– 4 Angela Espitia,1,2 Camilo Pizarro,3,4 Joaquim Gea,5,6 Victor R Castillo,7,8 Mauricio Orozco-Levi1– 3,6 1Respiratory Department, Instituto Cardiovascular y Hospital Internacional de Colombia, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia; 2EMICON Research Group MINCIENCIAS, Bogotá, Cundinamarca, Colombia; 3Universidad de Santander (UDES), Bucaramanga, Santander, Colombia; 4Department of Critical Care, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia; 5Respiratory Department, Parc de Salut Mar, Barcelona, Catalonia, Spain; 6CEXS-Universidad Pompeu Fabra, Barcelona, Catalonia, Spain; 7Department of Cardiovascular Surgery, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia; 8Biomedical and Translational Research Group, Fundación Cardiovascular de Colombia, Floridablanca, Santander, ColombiaCorrespondence: Mauricio Orozco-LeviRespiratory Department, ICV-HIC, Fundación Cardiovascular de Colombia, Calle 155a no. 23-58, El Bosque, Floridablanca, Santander, ColombiaTel +57 3175741421Email mauricioorozco@fcv.orgBackground: Bronchoaspiration of content that accumulates in the supraglottic area (eg, saliva, gastroesophageal reflux) is a risk factor for ventilator-associated pneumonia. A continuous supraglottic suction system may decrease the risk of bronchoaspiration in these patients.Objective: (1) Constructing a conceptual model and functional prototype of a continuous supraglottic suction device for use in humans; (2) defining functional characteristics in ex vivo swine head models; and (3) evaluating its efficacy and safety in mechanically ventilated patients.Methods: Study conducted in three phases. First phase: definition of distances and diameters of the triangle determined by dental arch, posterior oropharynx and vallecula, and diameter of the oropharynx in axial projection; and identification of the declining area of supraglottic suction. Second phase: design engineering and functional prototype evaluated in ex vivo models. Third phase: evaluation of device use in terms of safety and efficacy in ventilated patients.Results: We obtained a final functional model of the SUPRAtube device injected into PVC for medical use. Device effectiveness in in vitro simulation showed a high and fast suction capacity of liquid and thick volumes. Study of swine heads allowed to validate the shape, size and functional fenestration of the device. Study in intubated and mechanically ventilated patients showed a high supraglottic suction capacity and the absence of local adverse events during 72 (7– 240) hours of continuous operation.Conclusion: Our study describes the process of conceptualization, design and production of a practical, safe, low-cost continuous supraglottic suction device without representing antibiotic pressure, which appears to be a new complementary preventive strategy for the standard management of intubated and mechanically ventilated patients.Keywords: mechanical ventilation, bronchoaspiration, supraglottic suction, SUPRAtube, endotracheal tube, gastroesophageal refluxRamírez-Sarmiento AAya OCáceres-Rivera DReyes CFEspitia APizarro CGea JCastillo VROrozco-Levi MDove Medical Pressarticlemechanical ventilationbronchoaspirationsupraglottic suctionsupratubeendotracheal tubegastroesophageal reflux.Medical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 14, Pp 287-297 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	mechanical ventilation bronchoaspiration supraglottic suction supratube endotracheal tube gastroesophageal reflux. Medical technology R855-855.5
spellingShingle	mechanical ventilation bronchoaspiration supraglottic suction supratube endotracheal tube gastroesophageal reflux. Medical technology R855-855.5 Ramírez-Sarmiento A Aya O Cáceres-Rivera D Reyes CF Espitia A Pizarro C Gea J Castillo VR Orozco-Levi M Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients
description	Alba Ramírez-Sarmiento,1– 3 Orlando Aya,3,4 Diana Cáceres-Rivera,1,2 Carlos F Reyes,2– 4 Angela Espitia,1,2 Camilo Pizarro,3,4 Joaquim Gea,5,6 Victor R Castillo,7,8 Mauricio Orozco-Levi1– 3,6 1Respiratory Department, Instituto Cardiovascular y Hospital Internacional de Colombia, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia; 2EMICON Research Group MINCIENCIAS, Bogotá, Cundinamarca, Colombia; 3Universidad de Santander (UDES), Bucaramanga, Santander, Colombia; 4Department of Critical Care, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia; 5Respiratory Department, Parc de Salut Mar, Barcelona, Catalonia, Spain; 6CEXS-Universidad Pompeu Fabra, Barcelona, Catalonia, Spain; 7Department of Cardiovascular Surgery, Fundación Cardiovascular de Colombia, Floridablanca, Santander, Colombia; 8Biomedical and Translational Research Group, Fundación Cardiovascular de Colombia, Floridablanca, Santander, ColombiaCorrespondence: Mauricio Orozco-LeviRespiratory Department, ICV-HIC, Fundación Cardiovascular de Colombia, Calle 155a no. 23-58, El Bosque, Floridablanca, Santander, ColombiaTel +57 3175741421Email mauricioorozco@fcv.orgBackground: Bronchoaspiration of content that accumulates in the supraglottic area (eg, saliva, gastroesophageal reflux) is a risk factor for ventilator-associated pneumonia. A continuous supraglottic suction system may decrease the risk of bronchoaspiration in these patients.Objective: (1) Constructing a conceptual model and functional prototype of a continuous supraglottic suction device for use in humans; (2) defining functional characteristics in ex vivo swine head models; and (3) evaluating its efficacy and safety in mechanically ventilated patients.Methods: Study conducted in three phases. First phase: definition of distances and diameters of the triangle determined by dental arch, posterior oropharynx and vallecula, and diameter of the oropharynx in axial projection; and identification of the declining area of supraglottic suction. Second phase: design engineering and functional prototype evaluated in ex vivo models. Third phase: evaluation of device use in terms of safety and efficacy in ventilated patients.Results: We obtained a final functional model of the SUPRAtube device injected into PVC for medical use. Device effectiveness in in vitro simulation showed a high and fast suction capacity of liquid and thick volumes. Study of swine heads allowed to validate the shape, size and functional fenestration of the device. Study in intubated and mechanically ventilated patients showed a high supraglottic suction capacity and the absence of local adverse events during 72 (7– 240) hours of continuous operation.Conclusion: Our study describes the process of conceptualization, design and production of a practical, safe, low-cost continuous supraglottic suction device without representing antibiotic pressure, which appears to be a new complementary preventive strategy for the standard management of intubated and mechanically ventilated patients.Keywords: mechanical ventilation, bronchoaspiration, supraglottic suction, SUPRAtube, endotracheal tube, gastroesophageal reflux
format	article
author	Ramírez-Sarmiento A Aya O Cáceres-Rivera D Reyes CF Espitia A Pizarro C Gea J Castillo VR Orozco-Levi M
author_facet	Ramírez-Sarmiento A Aya O Cáceres-Rivera D Reyes CF Espitia A Pizarro C Gea J Castillo VR Orozco-Levi M
author_sort	Ramírez-Sarmiento A
title	Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients
title_short	Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients
title_full	Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients
title_fullStr	Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients
title_full_unstemmed	Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients
title_sort	invention and pilot study of the efficacy and safety of the supratube device in continuous supraglottic aspiration for intubated and mechanically ventilated patients
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/60d37fcace1a4349a979e66ec43c87eb
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Invention and Pilot Study of the Efficacy and Safety of the SUPRAtube Device in Continuous Supraglottic Aspiration for Intubated and Mechanically Ventilated Patients

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