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.

Risk factors for poor performance in finger cuff non-invasive monitoring of arterial pressure: A prospective multicenter study.

BACKGROUND: Compared to the invasive technique, non-invasive monitoring of arterial pressure favors easier and faster implementation while potentially sacrificing some reliability. This may be particularly true for the Clearsight™ system (Edwards Lifesciences), which enables continuous monitoring. We evaluated the risk factors for its poor performance. METHODS: Patients with an arterial catheter and stable mean arterial pressure (MAP) over a 5-min period were included. Six pairs of invasive and Clearsight measurements of MAP were collected and the bias between the two techniques was calculated. Poor performance of the Clearsight™ system was defined as either a failure to measure and display MAP or displaying an erroneous MAP (individual bias > 5 mmHg). Fingertip perfusion was assessed using the plethysmographic perfusion index (PI) and the capillary refill time (CRT). RESULTS: Among 152 ICU patients (MAP of 81 ± 14 mmHg, norepinephrine in 78 [51%]), 78 (51%) experienced a poor performance of the Clearsight™ system: failure to display MAP in 19 (13%) patients, and erroneous value displayed in 59 (44%). In multivariate analysis, PI ≤ 0.85% (adjusted odds ratio [aOR] = 2.94 [95% confidence interval (95%CI):1.34;6.45]), CRT > 4 s (aOR = 5.28 [95%CI 1.39;20.05]), and the presence of hand edema (aOR = 2.06 [95%CI 1.01;4.21]) were associated with a higher likelihood of poor performance. Cardiac arrhythmia (aOR = 1.39 [95%CI 0.64;3.02]) and other tested variables were not associated with poor performance. CONCLUSIONS: Half of the included patients exhibited poor Clearsight™ system performance. Our results caution against using finger cuff arterial pressure monitoring in patients with low PI (≤0.85%), protracted CRT (>4 s), or hand edema. REGISTRATION: ClinicalTrials.gov, NCT04269382, Dr. G. Muller, February 13, 2020. https://classic. CLINICALTRIALS: gov/ct2/show/NCT04269382.

Complications and risk factors on midline catheters' follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study).

INTRODUCTION: The midline catheter (MC) is an increasingly popular device used commonly for patients with difficult venous access or those who require infusion for more than 6 days. Little is known about complications such as infection, thrombosis or occlusion for inpatient and home care patient. This protocol presents the follow-up of non-intensive care unit patients with an MC. The aim is to identify complications and search for risk factors associated with these complications. METHOD AND ANALYSIS: A prospective observational design is used for the follow-up of 2000 patients from 13 centres in France. Each practitioner (inserting clinician, anaesthetist nurse, hospital nurse and home nurse) will fill out a logbook to report each care made (eg, number of saline flushes, dress maintenance) on the MC and if any complications occurred. The incidence of complications (ie, infections, thrombosis or occlusions) will be expressed by the total number of events per 1000 catheter days. The period of recruitment began in December 2019 for a duration of 2 years. An extension of the inclusion period of 1 year was obtained. ETHICS AND DISSEMINATION: This study received the approval of the Committee for the Protection of Persons of Nord Ouest IV (No EudraCT/ID-RCB : 2019-A02406-51). It was registered at clinical trials (NCT04131088). It is planned to communicate results at conferences and in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04131088.

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.

Effect of Active Physiotherapy With Positive Airway Pressure on Pulmonary Atelectasis After Cardiac Surgery: A Randomized Controlled Study.

OBJECTIVES: The authors investigated the effect of active work with positive airway pressure (PAP) in addition to chest physiotherapy (CP) on pulmonary atelectasis (PA) in patients undergoing cardiac surgery with cardiopulmonary bypass. DESIGN: A randomized controlled study. SETTING: At a single-center tertiary hospital. PARTICIPANTS: Eighty adult patients undergoing cardiac surgery (coronary artery bypass grafting, valve surgery, or both), and presenting with PA after tracheal extubation on postoperative days 1 or 2, were randomized from November 2014 to September 2016. INTERVENTION: Three days of CP, twice daily, associated with active work with PAP effect (intervention group) versus CP alone (control group). Pulmonary atelectasis was assessed by using the radiologic atelectasis score (RAS) measured from daily chest x-rays. All radiographs were reviewed blindly. MEASUREMENTS AND MAIN RESULTS: Among included patients, 79 (99%) completed the trial. The primary outcome was mean RAS on day 2 after inclusion. It was significantly lower in the intervention group (mean difference and 95% CI: -1.1 [-1.6 to -0.6], p < 0.001). The secondary outcomes were the sniff nasal inspiratory pressure measured before and after CP and clinical variables. Sniff nasal inspiratory pressure was significantly higher in the intervention group on day 2 (7.7 [3.0-12.5] cmH2O, p = 0.002). The respiratory rate was lower in the intervention group (-3.2 [95% CI -4.8 to -1.6] breaths/min, p < 0.001) on day 2. No differences were found between the 2 groups for percutaneous oxygen saturation/oxygen requirement ratio, heart rate, pain, and dyspnea scores. CONCLUSIONS: Active work with the PAP effect, combined with CP, significantly decreased the RAS of patients undergoing cardiac surgery after 2 days of CP, with no differences observed in clinically relevant parameters.

Noninvasive Monitoring of Arterial Pressure: Finger or Lower Leg As Alternatives to the Upper Arm: A Prospective Study in Three ICUs.

OBJECTIVES: When the upper arm is inaccessible for measurements of arterial pressure (AP), the best alternative site is unknown. We performed a between-site comparison of the agreement between invasive and noninvasive readings of AP taken at the lower leg, the finger, and the upper arm. The risk associated with measurement errors and the trending ability were also assessed. DESIGN: Prospective observational study. SETTING: Three ICUs. PATIENTS: Patients having an arterial catheter and an arm circumference less than 42 cm. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Three triplicates of AP measurements were collected via an arterial catheter (reference AP), a finger cuff system (ClearSight; Edward Lifesciences, Irvine, CA), and an oscillometric cuff (at the lower leg then the upper arm). Trending ability was assessed through an additional set of measurements after a cardiovascular intervention. The default bed backrest angle was respected. Failure to measure and display AP occurred in 19 patients (13%) at the finger, never at other sites. In 130 patients analyzed, the agreement between noninvasive and invasive readings was worse at the lower leg than that observed at the upper arm or the finger (for mean AP, bias ± sd of 6.0 ± 15.8 vs 3.6 ± 7.1 and 0.1 ± 7.4 mm Hg, respectively; p < 0.05), yielding a higher frequency of error-associated clinical risk (no risk for 64% vs 84% and 86% of measurements, respectively, p < 0.0001). According to the International Organization for Standardization (ISO) 81060-2:2018 standard, mean AP measurements were reliable at the upper arm and the finger, not the lower leg. In 33 patients reassessed after a cardiovascular intervention, both the concordance rate for change in mean AP and the ability to detect a therapy-induced significant change were good and similar at the three sites. CONCLUSIONS: As compared with lower leg measurements of AP, finger measurements were, when possible, a preferable alternative to upper arm ones.

The accuracy of intensive care nurses' interpretation of chest radiographs to recognise misplacement of endotracheal and nasogastric tubes after a single training session and comparison with residents' interpretation.

BACKGROUND: Misplacements of endotracheal and nasogastric tubes are frequent encounters in critically ill patients. OBJECTIVES: The purpose of this study was to assess the effectiveness of a single standardised training session on the ability of intensive care registered nurses (RNs) to recognise the misplacement of endotracheal and nasogastric tubes on bedside chest radiographs of patients in intensive care units (ICUs). METHODS: In eight French ICUs, RNs received a 110-min standardised teaching on the position of endotracheal and nasogastric tubes on chest radiographs. Their knowledge was evaluated within the subsequent weeks. For 20 chest radiographs, each with an endotracheal and nasogastric tube, RNs had to indicate whether each tube was in the proper or incorrect position. Training success was defined as >90% for the lower bound of the 95% confidence interval (95% CI) of the mean correct response rate (CRR). Residents of the participating ICUs underwent the same evaluation (without prior specific training). RESULTS: In total, 181 RNs were trained and evaluated and 110 residents were evaluated. The global mean CRR for RNs was 84.6% (95% CI: 83.3-85.9), significantly higher than for residents (81.4% [95% CI: 79.7-83.2]) (P < 0.0001). The mean CRR for RNs and residents was 95.9% (93.9-98.0) and 97.0% (94.7-99.3) for misplaced nasogastric tubes (P = 0.54), 86.8% (85.2-88.5) and 82.6% (79.4-85.7) (P = 0.07) for nasogastric tubes in the correct position, 86.6% (83.8-89.3) and 62.7% (57.9-67.5) for misplaced endotracheal tubes (P < 0.0001), and 79.1% (76.6-81.6) and 84.7% (82.1-87.2) for endotracheal tubes in the correct position (P = 0.01), respectively. CONCLUSIONS: The ability of trained RNs to detect tube misplacement did not reach the predetermined arbitrary level, indicating training success. Their mean CRR was higher than that for residents and was considered satisfactory for detecting misplaced nasogastric tubes. This finding is encouraging but insufficient to ensure patient safety. Transferring responsibility for reading radiographs to detect the misplacement of endotracheal tubes to intensive care RNs will need a more advanced or more in-depth teaching method.

Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study.

BACKGROUND: Intermittent manual correction of the endotracheal tube cuff pressure (Pcuff) may delay the detection of underinflation (source of contaminated oropharyngeal content microaspiration) or overinflation (exposing to airway damage). Devices for automated continuous correction of Pcuff are appealing but some are inconvenient, expensive or even harmful. This prospective randomised controlled study tested whether the tracoe Smart Cuff Manager™ reduced the rate of patients undergoing≥1 episode of underinflation (Pcuff<20 cmH2O), as compared with routine manual Pcuff correction. The rate of patients with≥1 overinflation episode (Pcuff>30 cmH2O) and the incidence of under/overinflation were also compared. METHODS: Patients with acute brain injury and likely to receive invasive mechanical ventilation for>48h were randomly allocated to receive, during 48h, automated Pcuff correction (combined with manual correction) or manual correction alone. Pcuff was measured with a dedicated manual manometer, at least every 8h. RESULTS: Sixty patients were included and randomised (32 patients with manual and 28 with automated Pcuff correction) for 506 measurements of Pcuff (269 and 237, respectively). Automated correction of Pcuff was associated with a lower rate of patients with≥1 episode of underinflation (63% and 18%, respectively, P<0.001), a lower incidence of underinflation episodes (15% vs. 2%; P<0.001), a lower rate of manual corrections (77% vs. 58%; P<0.001). For overinflation, there were no significant between-groups differences (2% vs. 2%). The incidence of early respiratory infections was similar in both groups (29% vs. 25%, P=0.78). CONCLUSIONS: The adjunction of continuous Pcuff control with the Tracoe Smart Cuff Manager™ to routine manual intermittent correction reduced the incidence of Pcuff underinflation episodes without provoking overinflation. TRIAL REGISTRATION: ClinicalTrials NCT03330379. Registered 6 November 2017, https://clinicaltrials.gov/ct2/show/NCT03330379.