The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial
Abstract Background Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the controversy surrounding the routine use of FB as part of the procedure remai...
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| Format: | Article |
| Language: | English |
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BMC
2021-06-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05370-x |
| _version_ | 1818440740174299136 |
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| author | José M. Añón María Soledad Arellano Manuel Pérez-Márquez Claudia Díaz-Alvariño José A. Márquez-Alonso Jorge Rodríguez-Peláez Kapil Nanwani-Nanwani Ana Martín-Pellicer Belén Civantos Alba López-Fernández Irene Seises Jorge García-Nerín Juan C. Figueira Henar Casero Javier Vejo Alexander Agrifoglio Lucía Cachafeiro Mariana Díaz-Almirón Jesús Villar |
| author_facet | José M. Añón María Soledad Arellano Manuel Pérez-Márquez Claudia Díaz-Alvariño José A. Márquez-Alonso Jorge Rodríguez-Peláez Kapil Nanwani-Nanwani Ana Martín-Pellicer Belén Civantos Alba López-Fernández Irene Seises Jorge García-Nerín Juan C. Figueira Henar Casero Javier Vejo Alexander Agrifoglio Lucía Cachafeiro Mariana Díaz-Almirón Jesús Villar |
| author_sort | José M. Añón |
| collection | DOAJ |
| description | Abstract Background Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the controversy surrounding the routine use of FB as part of the procedure remains open. National surveys in some European countries showed that the use of FB is non-standardized. Retrospective studies have not shown a significant difference in complications between procedures performed with or without a bronchoscope. International guidelines have not been able to establish recommendations regarding the use of FB in PDT due to lack of evidence. Design This is a multicenter (three centers at the time of publishing this paper) randomized controlled clinical trial to examine the safety of percutaneous tracheostomy using FB. We will include all consecutive adult patients admitted to the ICU in whom percutaneous tracheostomy for prolonged mechanical ventilation is indicated and with no exclusion criteria for using FB. Eligible patients will be randomly assigned to receive blind PDT or PDT under endoscopic guidance. All procedures will be performed by experienced intensivists in PDT and FB. A Data Safety and Monitoring Board (DSMB) will monitor the trial. The primary outcome is the incidence of perioperative complications. Discussion FB is a safe technique when performing PDT although its use is not universally accepted in all ICUs as a routine practice. Should PDT be monitored routinely with endoscopic guidance? This study will assess the role of FB monitoring during PDT. Trial registration ClinicalTrials.gov NCT04265625. Registered on February 11, 2020 |
| first_indexed | 2024-12-14T18:17:09Z |
| format | Article |
| id | doaj.art-2667895058fe437a9044c8f46ba5f795 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T18:17:09Z |
| publishDate | 2021-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2667895058fe437a9044c8f46ba5f7952022-12-21T22:52:10ZengBMCTrials1745-62152021-06-012211710.1186/s13063-021-05370-xThe role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trialJosé M. Añón0María Soledad Arellano1Manuel Pérez-Márquez2Claudia Díaz-Alvariño3José A. Márquez-Alonso4Jorge Rodríguez-Peláez5Kapil Nanwani-Nanwani6Ana Martín-Pellicer7Belén Civantos8Alba López-Fernández9Irene Seises10Jorge García-Nerín11Juan C. Figueira12Henar Casero13Javier Vejo14Alexander Agrifoglio15Lucía Cachafeiro16Mariana Díaz-Almirón17Jesús Villar18Intensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario Rey Juan CarlosIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario Rey Juan CarlosIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario Rey Juan CarlosIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazIntensive Care Unit, Hospital Universitario La PazBiostatistics Research Unit, Hospital Universitario La PazCIBER de Enfermedades Respiratorias, Instituto de Salud Carlos IIIAbstract Background Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the controversy surrounding the routine use of FB as part of the procedure remains open. National surveys in some European countries showed that the use of FB is non-standardized. Retrospective studies have not shown a significant difference in complications between procedures performed with or without a bronchoscope. International guidelines have not been able to establish recommendations regarding the use of FB in PDT due to lack of evidence. Design This is a multicenter (three centers at the time of publishing this paper) randomized controlled clinical trial to examine the safety of percutaneous tracheostomy using FB. We will include all consecutive adult patients admitted to the ICU in whom percutaneous tracheostomy for prolonged mechanical ventilation is indicated and with no exclusion criteria for using FB. Eligible patients will be randomly assigned to receive blind PDT or PDT under endoscopic guidance. All procedures will be performed by experienced intensivists in PDT and FB. A Data Safety and Monitoring Board (DSMB) will monitor the trial. The primary outcome is the incidence of perioperative complications. Discussion FB is a safe technique when performing PDT although its use is not universally accepted in all ICUs as a routine practice. Should PDT be monitored routinely with endoscopic guidance? This study will assess the role of FB monitoring during PDT. Trial registration ClinicalTrials.gov NCT04265625. Registered on February 11, 2020https://doi.org/10.1186/s13063-021-05370-xPercutaneous tracheostomyEndoscopic guideFiberoptic bronchoscopyComplicationsProlonged mechanical ventilation |
| spellingShingle | José M. Añón María Soledad Arellano Manuel Pérez-Márquez Claudia Díaz-Alvariño José A. Márquez-Alonso Jorge Rodríguez-Peláez Kapil Nanwani-Nanwani Ana Martín-Pellicer Belén Civantos Alba López-Fernández Irene Seises Jorge García-Nerín Juan C. Figueira Henar Casero Javier Vejo Alexander Agrifoglio Lucía Cachafeiro Mariana Díaz-Almirón Jesús Villar The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial Trials Percutaneous tracheostomy Endoscopic guide Fiberoptic bronchoscopy Complications Prolonged mechanical ventilation |
| title | The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial |
| title_full | The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial |
| title_fullStr | The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial |
| title_full_unstemmed | The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial |
| title_short | The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial |
| title_sort | role of routine fiberoptic bronchoscopy monitoring during percutaneous dilatational tracheostomy fibertrach a study protocol for a randomized controlled clinical trial |
| topic | Percutaneous tracheostomy Endoscopic guide Fiberoptic bronchoscopy Complications Prolonged mechanical ventilation |
| url | https://doi.org/10.1186/s13063-021-05370-x |
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