Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial
Introduction Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index (HPI) developed using machine learning techniques, allows the prediction of arterial hypotension analysing the arterial pressure waveform. The use of this index may reduc...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e051728.full |
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| author | Javier Ripollés-Melchor Ane Abad-motos Juan Victor Lorente Ignacio Jimenez Alejandra Becerra Wilbert Wesselink Francesca Reguant Irene Mojarro Maria de los Angeles Fuentes Elizabeth Agudelo Francisco Herrero-Machancoses Paula Callejo Joan Bosch Manuel Ignacio Monge |
| author_facet | Javier Ripollés-Melchor Ane Abad-motos Juan Victor Lorente Ignacio Jimenez Alejandra Becerra Wilbert Wesselink Francesca Reguant Irene Mojarro Maria de los Angeles Fuentes Elizabeth Agudelo Francisco Herrero-Machancoses Paula Callejo Joan Bosch Manuel Ignacio Monge |
| author_sort | Javier Ripollés-Melchor |
| collection | DOAJ |
| description | Introduction Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index (HPI) developed using machine learning techniques, allows the prediction of arterial hypotension analysing the arterial pressure waveform. The use of this index may reduce the duration and severity of intraoperative hypotension in adults undergoing non-cardiac surgery. This study aims to determine whether a treatment protocol based on the prevention of arterial hypotension using the HPI algorithm reduces the duration and severity of intraoperative hypotension compared with the recommended goal-directed fluid therapy strategy and may improve tissue oxygenation and organ perfusion.Methods and analysis We will conduct a multicentre, randomised, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. All participants will be randomly assigned to a control or intervention group. Haemodynamic management in the control group will be based on standard haemodynamic parameters. Haemodynamic management of patients in the intervention group will be based on functional haemodynamic parameters provided by the HemoSphere platform (Edwards Lifesciences), including dynamic arterial elastance, dP/dtmax and the HPI. Tissue oxygen saturation will be recorded non-invasively and continuously by using near-infrared spectroscopy technology. Biomarkers of acute kidney stress (cTIMP2 and IGFBP7) will be obtained before and after surgery. The primary outcome will be the intraoperative time-weighted average of a mean arterial pressure <65 mm Hg.Ethics and dissemination Ethics committee approval was obtained from the Ethics Committee of Hospital Gregorio Marañón (Meeting of 27 July 2020, minutes 18/2020, Madrid, Spain). Findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT04301102. |
| format | Article |
| id | doaj-art-5884f17fa2434ebeb552fc363a1592de |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5884f17fa2434ebeb552fc363a1592de2025-01-28T02:30:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-051728Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trialJavier Ripollés-Melchor0Ane Abad-motos1Juan Victor Lorente2Ignacio Jimenez3Alejandra Becerra4Wilbert Wesselink5Francesca Reguant6Irene Mojarro7Maria de los Angeles Fuentes8Elizabeth Agudelo9Francisco Herrero-Machancoses10Paula Callejo11Joan Bosch12Manuel Ignacio Monge13Anesthesia and Critical Care, Infanta Leonor University Hospital, Madrid, SpainAnesthesia and Critical Care, Infanta Leonor University Hospital, Madrid, SpainAnesthesia and Critical Care, Hospital Juan Ramon Jimenez, Huelva, SpainAnesthesia and Critical Care, Virgen del Rocio University Hospital, Sevilla, SpainAnesthesia and Critical Care, Complejo Hospitalario Universitario de Badajoz, Badajoz, SpainEdwards Lifesciences Corp, Irvine, California, USASchool of Medicine and Health Science, Universitat Internacional de Catalunya, Barcelona, SpainAnesthesia and Critical Care, Hospital Juan Ramon Jimenez, Huelva, SpainAnesthesia and Critical Care, Virgen del Rocio University Hospital, Sevilla, SpainAnesthesia and Critical Care, Complejo Hospitalario Universitario de Badajoz, Badajoz, SpainPredepartamental Unit of Medicine, Science Health Faculty, Universitat Jaume I, Castello de la Plana, SpainFundación Progreso y Salud, Sevilla, SpainSchool of Medicine and Health Science, Universitat Internacional de Catalunya, Barcelona, SpainIntensive Care Unit, Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera, SpainIntroduction Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index (HPI) developed using machine learning techniques, allows the prediction of arterial hypotension analysing the arterial pressure waveform. The use of this index may reduce the duration and severity of intraoperative hypotension in adults undergoing non-cardiac surgery. This study aims to determine whether a treatment protocol based on the prevention of arterial hypotension using the HPI algorithm reduces the duration and severity of intraoperative hypotension compared with the recommended goal-directed fluid therapy strategy and may improve tissue oxygenation and organ perfusion.Methods and analysis We will conduct a multicentre, randomised, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. All participants will be randomly assigned to a control or intervention group. Haemodynamic management in the control group will be based on standard haemodynamic parameters. Haemodynamic management of patients in the intervention group will be based on functional haemodynamic parameters provided by the HemoSphere platform (Edwards Lifesciences), including dynamic arterial elastance, dP/dtmax and the HPI. Tissue oxygen saturation will be recorded non-invasively and continuously by using near-infrared spectroscopy technology. Biomarkers of acute kidney stress (cTIMP2 and IGFBP7) will be obtained before and after surgery. The primary outcome will be the intraoperative time-weighted average of a mean arterial pressure <65 mm Hg.Ethics and dissemination Ethics committee approval was obtained from the Ethics Committee of Hospital Gregorio Marañón (Meeting of 27 July 2020, minutes 18/2020, Madrid, Spain). Findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT04301102.https://bmjopen.bmj.com/content/12/6/e051728.full |
| spellingShingle | Javier Ripollés-Melchor Ane Abad-motos Juan Victor Lorente Ignacio Jimenez Alejandra Becerra Wilbert Wesselink Francesca Reguant Irene Mojarro Maria de los Angeles Fuentes Elizabeth Agudelo Francisco Herrero-Machancoses Paula Callejo Joan Bosch Manuel Ignacio Monge Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial BMJ Open |
| title | Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial |
| title_full | Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial |
| title_fullStr | Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial |
| title_full_unstemmed | Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial |
| title_short | Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial |
| title_sort | intraoperative haemodynamic optimisation using the hypotension prediction index and its impact on tissular perfusion a protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/6/e051728.full |
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