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.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: https://www.clinicaltrials.gov. Reference number: NCT04819425.

Prevalence, risk factors of the use of physical restraint and impact of a decision support tool: A before-and-after study.

BACKGROUND: Physical restraint is frequently used in intensive care units to prevent patients' life-threatening removal of indwelling devices. In France, their use is poorly studied. Therefore, to evaluate the need for physical restraint, we have designed and implemented a decision support tool. AIMS: Besides describing the prevalence of physical restraint use, this study aimed to assess whether the implementation of a nursing decision support tool had an impact on restraint use and to identify the factors associated with this use. STUDY DESIGN: A large observational, multicentre study with a repeated one-day point prevalence design was conducted. All adult patients hospitalized in intensive care units were eligible for this study. Two study periods were planned: before (control period) and after (intervention period) the deployment of the decision support tool and staff training. A multilevel model was performed to consider the centre effect. RESULTS: During the control period, 786 patients were included, and 510 were in the intervention period. The prevalence of physical restraint was 28% (95% CI: 25.1%-31.4%) and 25% (95% CI: 21.5%-29.1%) respectively (χ2 = 1.35; p = .24). Restraint was applied by the nurse and/or nurse assistant in 96% of cases in both periods, mainly to wrists (89% vs. 83%, p = .14). The patient-to-nurse ratio was significantly lower in the intervention period (1:3.0 ± 1 vs. 1:2.7 ± 0.7, p < .001). In multivariable analysis, mechanical ventilation was associated with physical restraint (aOR [95% CI] = 6.0 [3.5-10.2]). CONCLUSION: The prevalence of physical restraint use in France was lower than expected. In our study, the decision support tool did not substantially impact physical restraint use. Hence, the decision support tool would deserve to be assessed in a randomized controlled trial. RELEVANCE TO CLINICAL PRACTICE: The decision to physically restrain a patient could be protocolised and managed by critical care nurses. A regular evaluation of the level of sedation could allow the most deeply sedated patients to be exempted from physical restraint.