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.

Botulinum toxin effect on voluntary and stretch reflex-related torque produced by the quadriceps: an isokinetic pilot study.

BACKGROUND: An understanding of the mechanical effects of botulinum toxin type A (BoNT A) on spastic and voluntary muscle contraction may help predict functional responders. OBJECTIVE: To compare the effect of BoNT A on the voluntary and stretch reflex-related torques produced by activation of the rectus femoris (RF). METHODS: This was a prospective open study where 15 incomplete spinal cord injury patients, impaired by a stiff-knee gait, with RF hyperactivity in mid-swing quantified by formal gait analysis (GA), were assessed before and after RF BoNT A injection (Botox, 200 UI). MAIN OUTCOME MEASURES: Included isokinetic peak torque (and angle at peak torque) at 0° (supine) and 90° (seated) during passive stretch (10 deg/s, 90 deg/s, and 150 deg/s), and voluntary contraction (60 deg/s) of the quadriceps. Secondary measures included impairment by Modified Tardieu Scale (MTS), peak knee flexion and spatial-temporal data by GA, activity (6-minute walking test, timed stair climbing), and discomfort (Verbal Rating Scale). RESULTS: Voluntary torque decreased (-16%; P = .0004) but with only a trend toward a decrease in stretch reflex-related torque. The angle at spastic torque increased at 90 deg/s (+5°; P = .03), whereas MTS, peak knee flexion (+4°; P = .01), spatial-temporal data, timed stair climbing test (25%; P = .02), and discomfort were significantly improved. CONCLUSION: BoNT A appeared to delay the stretch-reflex angle at peak torque, whereas the voluntary torque decreased. After strict patient selection, BoNT A injection into the RF muscle led to improvements in impairment, activity, and discomfort.