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The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial.

ABSTRACT: BACKGROUND:The optimal securement method of endotracheal tubes is unknown but should prevent dislodgement while minimizing complications. The use of an endotracheal tube fastener might reduce complications among critically ill adults undergoing endotracheal intubation. METHODS:In this pragmatic, single-center, randomized trial, critically ill adults admitted to the medical intensive care unit (MICU) and expected to require invasive mechanical ventilation for greater than 24?h were randomized to adhesive tape or endotracheal tube fastener at the time of intubation. The primary endpoint was a composite of any of the following: presence of lip ulcer, endotracheal tube dislodgement (defined as moving at least 2?cm), ventilator-associated pneumonia, or facial skin tears anytime between randomization and the earlier of death or 48?h after extubation. Secondary endpoints included duration of mechanical ventilation and ICU and in-hospital mortality. RESULTS:Of 500 patients randomized over a 12-month period, 162 had a duration of mechanical ventilation less than 24?h and 40 had missing outcome data, leaving 153 evaluable patients randomized to tube fastener and 145 evaluable patients randomized to adhesive tape. Baseline characteristics were similar between the groups. The primary endpoint occurred 13 times in 12 (7.8%) patients in the tube fastener group and 30 times in 25 (17.2%) patients in the adhesive tape group (p?=?0.014) for an overall incidence of 22.0 versus 52.6 per 1000 ventilator days, respectively (p?=?0.020). Lip ulcers occurred in 4 (2.6%) versus 11 (7.3%) patients, or an incidence rate of 6.5 versus 19.5 per 1000 patient ventilator days (p?=?0.053) in the fastener and tape groups, respectively. The endotracheal tube was dislodged 7 times in 6 (3.9%) patients in the tube fastener group and 16 times in 15 (10.3%) patients in the tape group (p?=?0.03), reflecting incidences of 11.9 and 28.1 per 1000 ventilator days, respectively. Facial skin tears were similar between the groups. Mechanical ventilation duration and ICU and hospital mortality did not differ. CONCLUSION:The use of the endotracheal tube fastener to secure the endotracheal tubes reduces the rate of a composite outcome that included lip ulcers, facial skin tears, or endotracheal tube dislodgement compared to adhesive tape. TRIAL REGISTRATION:ClinicalTrials.gov NCT03760510. Retrospectively registered on November 30, 2018.

SUBMITTER: Landsperger JS

PROVIDER: S-EPMC6505126 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial.

Landsperger Janna S JS Byram Jesse M JM Lloyd Bradley D BD Rice Todd W TW

Critical care (London, England) 20190507 1

<h4>Background</h4>The optimal securement method of endotracheal tubes is unknown but should prevent dislodgement while minimizing complications. The use of an endotracheal tube fastener might reduce complications among critically ill adults undergoing endotracheal intubation.<h4>Methods</h4>In this pragmatic, single-center, randomized trial, critically ill adults admitted to the medical intensive care unit (MICU) and expected to require invasive mechanical ventilation for greater than 24 h were ...[more]

PMID: 31064406

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Project description:ImportanceMany patients who survive critical illness are left with laryngeal functional impairment from endotracheal intubation that permanently limits their recovery and quality of life. Although the risk for laryngeal injury increases with larger endotracheal tube sizes, there are no data delineating the association of smaller endotracheal tube sizes with survival or acute recovery from critical illness.ObjectiveTo determine if smaller endotracheal tubes are noninferior to larger endotracheal tubes with respect to critical illness outcomes.Design, setting, and participantsThis propensity score-matched retrospective cohort study included all adult patients who underwent endotracheal intubation in the emergency department or intensive care unit and received mechanical ventilation for at least 12 hours from June 2020 to November 2020 at a single tertiary referral academic medical center.ExposuresEndotracheal intubation.Main outcomes and measuresPropensity score-matched analyses were performed with respect to the primary end point of 30-day all-cause in-hospital survival as well as the secondary end points of duration of invasive mechanical ventilation, length of hospital stay, mean peak inspiratory pressure, 30-day readmission, need for reintubation, and need for tracheostomy or gastrostomy tube placement.ResultsOverall, 523 participants (64%) were men and 291 (36%) were women. Of these, 814 patients were categorized into 3 endotracheal tube groups: small for height (n = 182), appropriate for height (n = 408), and large for height (n = 224). There was not a significant difference in 30-day all-cause in-hospital survival between groups ([HR, 1.1; 95% CI, 0.7-1.7] for small vs appropriate; [HR, 1.1; 95% CI, 0.7-1.6] for large vs appropriate). Patients with small-for-height endotracheal tubes had longer intubation durations (mean difference, 32.5 hrs [95% CI, 6.4-58.6 hrs]) compared with patients with appropriate-for-height tubes.Conclusions and relevanceDespite differences in intubation duration, the results of this cohort study suggest that smaller endotracheal tube sizes are not associated with impaired survival or recovery from critical illness. They support future prospective exploration of the association of smaller endotracheal tube sizes with recovery from critical illness.

Project description:Endotracheal tube security is a critical safety issue. We compared the mobility of an in situ endotracheal tube secured with adhesive tape to the one secured with a new commercially available purpose-designed endotracheal tube-holder device (Haider Tube-Guard). We also observed for the incidence of oropharyngeal or facial trauma associated with the 2 tube fixation methods.Thirty adult patients undergoing general anesthesia with neuromuscular blockade were prospectively enrolled. Immediately after intubation, a single study author positioned the endotracheal tube tip in the distal trachea using a bronchoscope. Anesthesiologists caring for patients secured the tube in their normal fashion (always with adhesive tape). A force transducer was used to apply linear force, increasing to 15 N or until the principal investigator deemed that the force be aborted for safety reasons. The displacement of the endotracheal tube was measured with the bronchoscope. Any tape was then removed and the endotracheal tube secured with the Haider Tube-Guard device. The linear force was reapplied and the displacement of the endotracheal tube measured. The Haider Tube-Guard device was left in place for the duration of the case. The patient's face and oropharynx were examined for any evidence of trauma during surgery and in the recovery room. On discharge from the postanesthesia care unit, the patient answered a brief survey assessing for any subjective evidence of minor facial or oropharyngeal trauma.Under standardized tension, the endotracheal tube withdrew a mean distance of 3.4 cm when secured with adhesive tape versus 0.3 cm when secured with the Haider Tube-Guard (P <0.001). Ninety-seven percent of patients (29/30) experienced clinically significant endotracheal tube movement (>1 cm) when adhesive tape was used to secure the tube versus 3% (1/30) when the Haider Tube-Guard was used (P <0.001). Thirty percent of patients (9/30) were potentially deemed a high extubation risk (endotracheal tube movement >4 cm) when the endotracheal tube was secured with tape versus 0% (0/30) when secured with the Haider Tube-Guard (P = 0.004). Six patients with taped endotracheal tubes required the traction to be aborted before 15 N of force was achieved to prevent potential extubation as the tape either separated from the face or stretched to allow excessive endotracheal tube movement. None of the patients appeared to sustain any injury from the Haider Tube-Guard device.The Haider Tube-Guard significantly reduced the mobility of the endotracheal tube when compared with adhesive tape and was well tolerated in our observations.

Project description:IntroductionTracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.Methods and analysisThe endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.Ethics and disseminationThe study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.Trial registration detailsClinicalTrials.gov Identifier: NCT04079387; Pre-results.

Project description:BackgroundTo determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system) that continuously monitors and controls the cuff pressure (Pcuff), while facilitating the aspiration of subglottic secretions (SS).MethodsThis was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE) and serious AE (SAE) as a result of using AnapnoGuard (AG) 100 during mechanical ventilation. Secondary endpoints were: (1) mechanical complications rate (2) ICU staff satisfaction; (3) VAP occurrence; (4) length of mechanical ventilation; (5) length of Intensive Care Unit stay and mortality; (6) volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT) and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually.ResultsNo difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; p<0.01) and a trend to a greater volume of aspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total)); (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily)). No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7), hoarseness (42.9% vs. 75%; p = 0.55) and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65). Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP) (14.8% vs. 40%; p = 0.06), which were more frequently monomicrobial (25% vs. 70%; p = 0.03). No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality.ConclusionsThe use AG 100 system and AG tube in critically ill intubated patients is safe and effective in Pcuff control and SS drainage. Its protective role against VAP needs to be confirmed in a larger randomized trial.Trial registrationClinicalTrials.gov NCT01550978. Date of registration: February 21, 2012.

Project description:Background: Systemic inflammation is a whole body reaction that can have an infection-positive (i.e. sepsis) or infection-negative origin. It is important to distinguish between septic and non-septic presentations early and reliably, because this has significant therapeutic implications for critically ill patients. We hypothesized that a molecular classifier based on a small number of RNAs expressed in peripheral blood could be discovered that would: 1) determine which patients with systemic inflammation had sepsis; 2) be robust across independent patient cohorts; 3) be insensitive to disease severity; and 4) provide diagnostic utility. The overall goal of this study was to identify and validate such a molecular classifier. Methods and Findings: We conducted an observational, non-interventional study of adult patients recruited from tertiary intensive care units (ICU). Biomarker discovery was conducted with an Australian cohort (n = 105) consisting of sepsis patients and post -surgical patients with infection-negative systemic inflammation. Using this cohort, a four-gene classifier consisting of a combination of CEACAM4, LAMP1, PLA2G7 and PLAC8 RNA biomarkers was identified. This classifier, designated SeptiCyteÂ® Lab, was externally validated using RT-qPCR and receiver operating characteristic (ROC) curve analysis in five cohorts (n = 345) from the Netherlands. Cohort 1 (n=59) consisted of unambiguous septic cases and infection-negative systemic inflammation controls; SeptiCyteÂ® Lab gave an area under curve (AUC) of 0.96 (95% CI: 0.91-1.00). ROC analysis of a more heterogeneous group of patients (Cohorts 2-5; 249 patients after excluding 37 patients with infection likelihood possible) gave an AUC of 0.89 (95% CI: 0.85-0.93). Disease severity, as measured by Sequential Organ Failure Assessment (SOFA) score or the Acute Physiology and Chronic Health Evaluation (APACHE) IV score, was not a significant confounding variable. The diagnostic utility o f SeptiCyteÂ® Lab was evaluated by comparison to various clinical and laboratory parameters that would be available to a clinician within 24 hours of ICU admission. SeptiCyteÂ® Lab was significantly better at differentiating sepsis from infection-negative systemic inflammation than all tested parameters, both singly and in various logistic combinations. SeptiCyteÂ® Lab more than halved the diagnostic error rate compared to PCT in all tested cohorts or cohort combinations. Conclusions: SeptiCyteÂ® Lab is a rapid molecular assay that may be clinically useful in the management of ICU patients with systemic inflammation. SIRS and Sepsis ICU patients, admission samples Retrospective, mutli-site sutdy using retrospective physician adjudication as a comparator

Dataset Information

The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial.

Publications

The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial.

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