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.

Effect of a Musical Intervention During the Implantation of a Central Venous Catheter or a Dialysis Catheter in the Intensive Care Unit: A Prospective Randomized Pilot Study.

BACKGROUND: Listening to music may reduce anxiety during medical procedures. However, the magnitude of any effect may differ with respect to patient and procedure. We evaluated the effect of a musical intervention on patient anxiety during a central venous catheter or dialysis catheter implantation in an intensive care unit. METHODS: A prospective single-center controlled open-label 2-arm randomized trial was conducted in a medical intensive care unit (ICU) from February 2018 to February 2019. Patients undergoing central venous catheterization were randomized to listening to music or not during the procedure. Patients randomized to music listened to the Music Care application via headphones. The primary outcome was the change in anxiety assessed on a 100-mm Visual Analogue Scale between the beginning and end of the catheterization procedure. Secondary outcomes included postprocedural pain. RESULTS: We included 37 patients in the musical intervention group and 35 in the standard care group. The primary reasons for intensive care unit admission were the need for a central catheter for chemotherapy for hematologic malignancy and sepsis and/or septic shock in both groups. Postprocedural anxiety and pain assessments were missing in 1 (2.7%) and 4 (11.4%) patients in the intervention and standard care groups. We found no between-group difference in change in anxiety score: median -1 (interquartile range, -3 to 0) vs 0 (-3 to 0) in the musical intervention and standard care groups (median difference, -1 [-2 to 0]) (P = .24). Postprocedural pain score did not differ between the groups: median 0 (0-2) and 0 (0-3.75) in the musical intervention and standard care groups (median difference, -0 [0-0]) (P = .40). To account for missing outcome assessments, sensitivity analyses were performed using 2 extreme scenarios, one favoring the standard care group (scenario 1) and the other favoring the intervention group (scenario 2). In either scenario, change in anxiety score did not differ between the intervention and standard care groups: -1 (-3 to 0) vs 0 (-4 to 0) (P = .88) in scenario 1 and -1 (-3 to 0) vs 0 (-2.75 to 1) (P = .07) in scenario 2. CONCLUSIONS: In this first randomized pilot study of musical intervention for central venous catheterization in awake patients in the intensive care unit, the musical intervention did not reduce patients' anxiety as compared with usual care.

Adenosine-induced maximal coronary hyperemia for myocardial fractional flow reserve measurements: comparison of administration by femoral venous versus antecubital venous access.

BACKGROUND: Maximal hyperemia is a critical prerequisite for correct fractional flow reserve (FFR) measurements. Continuous administration of adenosine by femoral venous access is considered the gold-standard. However, antecubital venous access is used as an alternative route of administration due to the increasing popularity of radial versus femoral access for coronary catheterization. Because of a potentially larger cross sectional venous area in the arm-theoretically associated with slower flow velocities-and the extremely short half-life of adenosine, there are concerns whether this route of administration is truly equivalent to the femoral route. METHODS: Fifty randomly selected patients with coronary artery disease were included. FFR was measured with a pressure monitoring wire and the recording was digitally stored. Hyperemia was successively induced by adenosine via the antecubital vein at a dose of 140 microg kg(-1) min(-1) (A140), via the antecubital vein at a dose of 170 microg kg(-1) min(-1) (A170), and via the femoral vein at a dose of 140 microg kg(-1) min(-1) (F140). RESULTS: Induction of hyperemia by A140 yielded significantly lower hyperemic responses than compared with A170 (P = 0.038) and F140 (P = 0.005). No significant difference was seen between adenosine administration by A170 versus F140. Hyperemic stimulation by A140 underestimated lesion severity near the ischemic threshold of FFR more frequently than the other modalities. There were no differences in side-effects between any of the dosages and routes of administration. CONCLUSIONS: The intravenous application of adenosine via antecubital venous access is feasible but slightly less effective than the femoral approach. In this setting, an antecubital dosage of 170 microg kg(-1) min(-1) is comparable to the standard dosage of 140 microg kg(-1) min(-1) in the femoral vein. In some patients, this regimen might prevent an underestimation of lesion severity.