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CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

ABSTRACT: BACKGROUND:To 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). METHODS:This 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. RESULTS:No 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. CONCLUSIONS:The 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 REGISTRATION:ClinicalTrials.gov NCT01550978. Date of registration: February 21, 2012.

SUBMITTER: De Pascale G

PROVIDER: S-EPMC5426597 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

De Pascale Gennaro G Pennisi Mariano Alberto MA Vallecoccia Maria Sole MS Bello Giuseppe G Maviglia Riccardo R Montini Luca L Di Gravio Valentina V Cutuli Salvatore Lucio SL Conti Giorgio G Antonelli Massimo M

PloS one 20170511 5

<h4>Background</h4>To 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).<h4>Methods</h4>This 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 resul ...[more]

PMID: 28493877

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Project description:BackgroundThe 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.MethodsIn 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.ResultsOf 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.ConclusionThe 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 registrationClinicalTrials.gov NCT03760510. Retrospectively registered on November 30, 2018.

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: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:BackgroundSubglottic secretion had been proven as one of the causes of microaspiration and increased risk of ventilator-associated pneumonia (VAP). The role of ultrasound to detect subglottic secretion has not yet been established.PurposeThe purpose of this study is to determine the sensitivity and specificity of upper airway ultrasound (US) in the detection of subglottic secretions as compared to computed tomography (CT) scanning.Material and methodsA prospective observational study was carried out in adult trauma patients requiring mechanical ventilation and cervical CT scan. All patients had an endotracheal tube cuff-pressure maintained between 20 and 30 cm H2O. Airway US was performed at the bedside immediately before the patient was transferred to the CT scan suite. The sensitivity, specificity, and positive/negative predictive values (PPV, NPV) of the upper airway US detection of subglottic secretions were then calculated and compared with CT findings.ResultsFifty participants were consecutively included. Subglottic secretions were detected in 31 patients using upper airway US. The sensitivity and specificity of upper airway US in detecting subglottic secretion were 96.7% and 90%, respectively (PPV 93.5%, NPV 94.7%). 18 (58%) patients with subglottic secretions developed VAP during their ICU stay (p = 0.01). The area under the receiver operating curve (AUROC) was 0.977 (95% CI 0.936-1.00).ConclusionsUpper airway US is a useful tool for detecting subglottic secretions with high sensitivity and specificity.Clinical implicationsThis study shows: 1. Upper airway US may aid in detecting subglottic secretions, which are linked to VAP. 2. Detecting subglottic secretions at the bedside aids in determining the best frequency of subglottic aspiration to clean the subglottic trachea. 3. Upper airway US may also aid in detecting the correct ETT position. Trial registration Clinicaltrials.gov.Clinicaltrialsgov identifier NCT04739878 Date of registration 2nd May 2021 URL of trial registry record https://clinicaltrials.gov/ct2/show/NCT04739878 .

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CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

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CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

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