Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial.
<h4>Background</h4>Endotracheal tube fixation in ventilated patients must be appropriate to ensure security during mechanical ventilation and prevent skin lesions. The incidence of endotracheal tube-caused pressure ulcers ranges from 7% to 45%. Various endotracheal tube fixations are use...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2024-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0297349&type=printable |
| _version_ | 1797304745927376896 |
|---|---|
| author | Vanessa Zinzoni Lucie Planche Sophie Le Potier Laurence Robin Cécile Le Parco Philippe Terrat Marie-Hélène Leroyer Romain Atger Jérôme E Dauvergne Lucie Muller Laetitia Fontaine Célina Morand Pascaline Dennemont Ophélie Paillard Servane Vastral Baptiste Dardaine Sylvie Le Guillou Natacha Maquigneau Stéphanie Martin Jean-Claude Lachérade |
| author_facet | Vanessa Zinzoni Lucie Planche Sophie Le Potier Laurence Robin Cécile Le Parco Philippe Terrat Marie-Hélène Leroyer Romain Atger Jérôme E Dauvergne Lucie Muller Laetitia Fontaine Célina Morand Pascaline Dennemont Ophélie Paillard Servane Vastral Baptiste Dardaine Sylvie Le Guillou Natacha Maquigneau Stéphanie Martin Jean-Claude Lachérade |
| author_sort | Vanessa Zinzoni |
| collection | DOAJ |
| description | <h4>Background</h4>Endotracheal tube fixation in ventilated patients must be appropriate to ensure security during mechanical ventilation and prevent skin lesions. The incidence of endotracheal tube-caused pressure ulcers ranges from 7% to 45%. Various endotracheal tube fixations are used in intensive care units (ICUs) worldwide. By pressure exercised on the skin, these systems could lead to mucosal and skin peri-oral lesions. The main objective of this study is to evaluate the impact of the two fixation systems most commonly used in French ICUs (adhesive elastic band versus fixation cord with PolyVinyl Chloride (PVC) sheath) on the incidence of these peri-oral skin lesions.<h4>Methods</h4>This studyis a multicenter, open-label, controlled, superiority, cluster cross-over randomized trial. 768 patients will be recruited in the 16 ICUs involved. The inclusion of patients will be carried out over two 12-month periods. Each site begins with one of the evaluated fixation systems: elastic adhesive tape or cord associated with a protective sheath. After a 4-month break, each site switches to the other fixation system. The primary outcome is the development of at least one peri-oral lesion during the first ten days of maintaining an orally inserted endotracheal tube. The presence of lesions is assessed by a blinded adjudication committee using photographs taken daily.<h4>Discussion</h4>This study is the first multicenter, randomized trial designed to evaluate the impact of elastic adhesive tape versus fixation cord with PVC sheath on the incidence of peri-oral lesions. The results will provide data which could change and standardize care practices.<h4>Trial registration</h4>https://www.clinicaltrials.gov. Reference number: NCT04819425. |
| first_indexed | 2024-03-08T00:14:57Z |
| format | Article |
| id | doaj.art-450d114904934615bf17be1bb312fae1 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-03-08T00:14:57Z |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-450d114904934615bf17be1bb312fae12024-02-17T05:33:00ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01192e029734910.1371/journal.pone.0297349Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial.Vanessa ZinzoniLucie PlancheSophie Le PotierLaurence RobinCécile Le ParcoPhilippe TerratMarie-Hélène LeroyerRomain AtgerJérôme E DauvergneLucie MullerLaetitia FontaineCélina MorandPascaline DennemontOphélie PaillardServane VastralBaptiste DardaineSylvie Le GuillouNatacha MaquigneauStéphanie MartinJean-Claude Lachérade<h4>Background</h4>Endotracheal tube fixation in ventilated patients must be appropriate to ensure security during mechanical ventilation and prevent skin lesions. The incidence of endotracheal tube-caused pressure ulcers ranges from 7% to 45%. Various endotracheal tube fixations are used in intensive care units (ICUs) worldwide. By pressure exercised on the skin, these systems could lead to mucosal and skin peri-oral lesions. The main objective of this study is to evaluate the impact of the two fixation systems most commonly used in French ICUs (adhesive elastic band versus fixation cord with PolyVinyl Chloride (PVC) sheath) on the incidence of these peri-oral skin lesions.<h4>Methods</h4>This studyis a multicenter, open-label, controlled, superiority, cluster cross-over randomized trial. 768 patients will be recruited in the 16 ICUs involved. The inclusion of patients will be carried out over two 12-month periods. Each site begins with one of the evaluated fixation systems: elastic adhesive tape or cord associated with a protective sheath. After a 4-month break, each site switches to the other fixation system. The primary outcome is the development of at least one peri-oral lesion during the first ten days of maintaining an orally inserted endotracheal tube. The presence of lesions is assessed by a blinded adjudication committee using photographs taken daily.<h4>Discussion</h4>This study is the first multicenter, randomized trial designed to evaluate the impact of elastic adhesive tape versus fixation cord with PVC sheath on the incidence of peri-oral lesions. The results will provide data which could change and standardize care practices.<h4>Trial registration</h4>https://www.clinicaltrials.gov. Reference number: NCT04819425.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0297349&type=printable |
| spellingShingle | Vanessa Zinzoni Lucie Planche Sophie Le Potier Laurence Robin Cécile Le Parco Philippe Terrat Marie-Hélène Leroyer Romain Atger Jérôme E Dauvergne Lucie Muller Laetitia Fontaine Célina Morand Pascaline Dennemont Ophélie Paillard Servane Vastral Baptiste Dardaine Sylvie Le Guillou Natacha Maquigneau Stéphanie Martin Jean-Claude Lachérade Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. PLoS ONE |
| title | Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. |
| title_full | Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. |
| title_fullStr | Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. |
| title_full_unstemmed | Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. |
| title_short | Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. |
| title_sort | impact of two endotracheal tube fixation on the incidence of peri oral lesions elastic adhesive strips versus cord in a protective sheath study protocol for a cluster cross over randomized trial |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0297349&type=printable |
| work_keys_str_mv | AT vanessazinzoni impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT lucieplanche impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT sophielepotier impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT laurencerobin impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT cecileleparco impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT philippeterrat impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT marieheleneleroyer impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT romainatger impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT jeromeedauvergne impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT luciemuller impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT laetitiafontaine impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT celinamorand impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT pascalinedennemont impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT opheliepaillard impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT servanevastral impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT baptistedardaine impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT sylvieleguillou impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT natachamaquigneau impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT stephaniemartin impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial AT jeanclaudelacherade impactoftwoendotrachealtubefixationontheincidenceofperiorallesionselasticadhesivestripsversuscordinaprotectivesheathstudyprotocolforaclustercrossoverrandomizedtrial |