Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. The composite of tube dislodgement, lip ulcer, and skin tear per 1000 patient ventilator days was significantly lower in the endotracheal tube fastener group compared to that in the adhesive tape group (p=0.017). Sign up to hear about new product launches, deals, events, CEUs and other educational resources. You are unable to select more than your available quota at this time. Cookies policy. %PDF-1.5 % JSL, JMB, BDL, and TWR contributed to the manuscript preparation, drafting, critique, and review. Ann Emerg Med. The use of an endotracheal tube fastener might reduce complications among critically ill adults undergoing endotracheal intubation. endstream endobj startxref Br J Anaesth. Data were collected prospectively at the time of intubation and from the medical record in order to determine the effect of the assigned intervention on short- and long-term outcomes. While many respiratory therapists may have a personal preference towards one particular securement technique, usually due to ease of use, superiority of one technique over another with regard to outcomes has not previously been demonstrated. Egyptian J Chest Dis Tuberc. CONSORT diagram showing the enrollment of patients into the endotracheal tube securement (ETTS) randomized controlled trial. Patients were excluded if they (1) were intubated greater than 12h prior to admission to the MICU, (2) had oral mucosa or facial skin breakdown prior to enrollment, (3) required nasotracheal intubation, (4) had a documented allergy to tape, (5) were pregnant, or (6) were prisoners. Prior to initiation of the study, randomization assignments were placed in sequentially numbered opaque envelopes, which remained sealed until the decision was made to enroll a patient in the study. Different endotracheal tube securement techniques may have different effects on these complications. Heart Lung. Terms and Conditions, The primary outcome measure was a composite of any of the following: development of lip ulcer, ventilator-associated pneumonia, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48h after extubation. Lip ulcer occurred in 4 (2.6%) versus 11 (7.3%) (p=0.05) patients for rates of 6.8 (95% CI 5.6 to 8.0) versus 19.3 (95% CI 17.1 to 21.6) per 1000 patient ventilator days (p=0.052) while facial skin tears occurred in 2 (1.4%) versus 3 (2.1%) patients for rates of 3.4 (95% CI 2.0 to 4.8) versus 5.3 (95% CI 4.7 to 5.9) per 1000 patient ventilator days (p=0.622) in the fastener and tape groups (p=0.61), respectively. Additionally, in 2014, Mohammed and Hassan demonstrated that securement with twill decreased endotracheal tube slippage in the first 120min post intubation compared to tape and tube fastener [2]. The following in-hospital outcomes were recorded via electronic medical record review: days on mechanical ventilation, and vital status at the time of ICU and hospital discharge. 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. 2007;50(6):68691. Both adhesive tape and endotracheal tube holder were being used in the MICU according to the clinicians choice prior to initiating the study. Power and sample size calculations: a review and computer program. The trial was led by an advanced practice provider and run by respiratory therapists. David R. Janz, MD, Louisiana State University School of Medicine, New Orleans, LA, USA. Once it had been determined by the treating team that a patient was eligible for the study (i.e., intubated less than 12h), the operator opened the envelope and followed the assignment of either adhesive tape or endotracheal tube fastener. 1). Continuous outcomes were compared with the Mann-Whitney U test and categorical variables with the chi-square or Fisher exact test as appropriate. Facial skin tears were similar between the groups. Article The trial has limitations. Part of Multivariate analysis including age as a covariate demonstrated no independent association between age and development of the composite endpoint (OR 1.00; 95% CI 0.981.02; p=0.84) and similar OR for the development of the composite endpoint in adhesive tape versus tube fastener (OR 2.32; 95% CI 1.114.76; p=0.026). In addition, the composite outcomes of the primary endpoint were independently confirmed by either the quality nurse associate or study personnel. In conclusion, in this trial involving critically ill adults, securement of an endotracheal tube with a tube fastener resulted in a lower incidence of and fewer patients experiencing lip ulcers, endotracheal tube dislodgements, or facial skin tears compared to securement with adhesive tape. Baseline characteristics were similar between the groups. Utilizing an endotracheal tube securement technique that enables providers to perform oral hygiene is imperative. In addition, as per usual practice in our ICU, facial skin tears and lip ulcers were independently assessed and confirmed by the nursing quality improvement associate, who was not part of either the patient care or the study team. UL1 TR002243 from the National Center for Advancing Translational Sciences. Janna S. Landsperger. Chastre J, Fagon JV. ICU mortality was similar, with 52 patients (34.0%) in the tube fastener group and 51 patients (35.2%) in the adhesive tape group dying before ICU discharge (p=0.83). Tracheal intubation in the critically ill: a multi-centre national study of practice and complications. Google Scholar. 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. JSL and TWR contributed to the study concept and design, data analysis and interpretation, and statistical methods and statistical data analysis. All authors approved the final version of the manuscript submitted. Retrospectively registered on November 30, 2018. This manuscripts contents are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. 1206 0 obj <> endobj Mechanical ventilation duration and ICU and hospital mortality did not differ. Provided by the Springer Nature SharedIt content-sharing initiative. Customer Terms & ConditionsPrivacyTerms of UseCode of ConductSupplier Code of ConductSupplier Terms and ConditionsReturn Policy5000 Tuttle Crossing Blvd., Dublin, OH 43016800.533.0523, 5000 Tuttle Crossing Blvd., Dublin, OH 43016, Endotracheal Tube Twill Tape, Bleached, 1/4in x 36yd. Oral mucosa assessment, facial skin integrity assessment, frequency of endotracheal tube repositioning, and endotracheal tube dislodgementsdefined as either complete dislodgement of the endotracheal tube (i.e., accidental extubation) or needing to reposition the endotracheal tube at least 2cm (i.e., need to pull ETT back >2cm or move it down >2cm)were all collected in duplicate using bedside sheets completed by nursing and respiratory therapy and electronic medical record review. However, endpoints were objective and strictly defined, thus limiting the subjectivity of the evaluation. Respir Care. Comparison of two endotracheal tube securement techniques on unplanned extubation, oral mucosa, and facial skin integrity. Australian Crit Care. Inclusion and enrollment of patients. The primary endpoint was a composite of any of the following: presence of lip ulcer, endotracheal tube dislodgement (defined as moving at least 2cm), ventilator-associated pneumonia, or facial skin tears anytime between randomization and the earlier of death or 48h after extubation. Total ventilation time for all 153 patients in the tube fastener group was 590days (mean duration 3.93.0days) compared to 570days for the 145 patients in the tape group (mean duration 3.93.4days) (p=0.75). Zaratkiewicz S, Teegardin C. Retrospective review of the reduction of oral pressure ulcers in mechanically ventilated patients: a change in practice. Of 500 patients randomized over a 12-month period, 162 had a duration of mechanical ventilation less than 24h and 40 had missing outcome data, leaving 153 evaluable patients randomized to tube fastener and 145 evaluable patients randomized to adhesive tape. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Additionally, endotracheal intubation and mechanical ventilation are associated with ventilator-associated pneumonia. Crit Care 23, 161 (2019). Google Scholar. Manage cookies/Do not sell my data we use in the preference centre. %%EOF Age, gender, height, weight, race, active medical problems at the time of intubation, active comorbidities complicating intubation, indication for intubation, whether a reintubation, and whether the face was soiled during the intubation were all collected at the time of intubation. In both groups, the tube was repositioned as needed according to ICU policy or protocols or at the discretion of the provider, bedside nurse, or respiratory therapist, per usual practice. However, given this study was undertaken in cadavers, it is unclear if these results translate to adult patients in the ICU. Primary endpoint. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. We conducted an unadjusted analysis examining the treatment effect of endotracheal tube securement method on each of the pre-specified secondary and tertiary outcomes. All data were collected non-invasively and were already a part of clinical data obtained in usual ICU care at the bedside or in the medical record. The authors declare that they have no competing interests. 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 24h were randomized to adhesive tape or endotracheal tube fastener at the time of intubation. Proper oral hygiene is essential in decreasing the incidence of ventilator-associated pneumonia [8]. The endotracheal tube was dislodged 7 times in 6 (3.9%) patients in the tube fastener group and 16 times in 15 patients (10.3%) in the adhesive tape group (p=0.030), with rates of 11.9 (95% CI 6.5 to 17.3) versus 28.1 (95% CI 24.4 to 31.8) per 1000 patient ventilator days (p=0.035). The primary endpoint was the continuous variable of incidences of lip ulcers, tube dislodgement, or ventilator-associated pneumonia per 1000 ventilator days. Patients admitted to the MICU from May 17, 2017, to April 14, 2018, who were deemed by their clinical team to require endotracheal intubation and fulfill the inclusion criteria without meeting the exclusion criteria were enrolled and randomly assigned to adhesive tape versus endotracheal tube fastener. Critical Care There are many potential complications during endotracheal tube intubation, including laryngeal trauma, bronchospasm, hypotension, hypoxemia, airway perforation, and vertebral column injury [1]. CAS Results showed that tape required a significantly larger force to extubate the cadavers compared to fastener. This 0.8% loss to follow-up rate was considerably less than anticipated when calculating the sample size needed to power the study and is unlikely to have significantly altered the results. Patients had to be enrolled in the study for a minimum of 24h to be included in the analysis to ensure a reasonable amount of time for complications to occur. Shimizu T, Mizutani T, Yamashita S, Hagiya K, Tanaka M. Endotracheal tube extubation force: adhesive tape versus endotracheal tube holder. Am J Respir Crit Care Med. Article One hundred fifty-three were randomized to the tube fastener and 145 were randomized to adhesive tape (Fig. Cite this article. Endotracheal tube dislodgements were retrospectively confirmed by a study personnel via manual chart review. While the securement device may have obscured some lip ulcers or skin tears while it was being used, all patients were assessed for these complications both daily and when the securement device was ultimately removed. Depth of the tube as measured at the lip line and position in the mouth (i.e., 22cm at the lip, midline) at time of securement was also recorded. Using the sum of these overall incidences (i.e., 21.1 per 1000 ventilator days) and a standard deviation of 15 per 1000 ventilator days, PS software [9] calculated a need for 142 evaluable patients in each arm to detect a clinically meaningful change of 5 episodes per 1000 ventilator days with 80% power at a two-sided alpha level of 0.05. Ventilator-associated pneumonia. Although both tube fasteners and adhesive tube have been used to secure endotracheal tubes in patients in clinical practice for several years, few trials have directly compared the effects of these different securement techniques on patient safety and clinical outcomes [2]. 2002;165(7):867903. The differences between the two groups were compared using Mann-Whitney U test. Springer Nature. During this project, Dr. Rice was supported by the VICTR Learning Healthcare System Platform under CTSA award no. 2012;108:7929. The study was approved by the Vanderbilt University Medical Center Institutional Review Board with a waiver of consent. Controlled Clin Trials. Dupont WD, Plummer WD. Secondary endpoints included duration of mechanical ventilation and ICU and in-hospital mortality. As hospital-acquired pressure injuries, treatment of these complications is not reimbursed. Prior studies investigating endotracheal tube securement techniques require that the endotracheal tube be repositioned and re-taped every 24h. However, due to the pragmatic design and intent of this protocol, the endotracheal tube was not repositioned as part of the study protocol in either group. Of 500 patients randomized, 162 were deemed excluded from the analysis due to the duration of mechanical ventilation less than 24h and 40 had missing outcome data, leaving 298 in the analysis. The composite endpoint would have needed to occur in almost 20% of the 16 patients randomized to tube fastener with missing envelopes, a rate almost three times higher than that occurred in the other patients enrolled in the tube fastener arm of the study. https://doi.org/10.1186/s13054-019-2440-7, DOI: https://doi.org/10.1186/s13054-019-2440-7. There were no occurrences of ventilator-associated pneumonia in either group. 2012;35(3):24754. volume23, Articlenumber:161 (2019) 2011;56(11):18259. JSL, JMB, and BDL contributed to the acquisition of the data. Conduct at a single academic center limits generalizability. Lip ulcers and facial skin tears are infrequent complications of endotracheal tube securement [2,3,4], but each is associated with increased financial burden and potentially increased length of stay [2]. Endotracheal tube dislodgement sometimes resulting in unplanned extubation, bronchospasm, or tracheal injury is another more common complication of suboptimal tube securement [5,6,7]. et al. Please contact your administrator for assistance. Correspondence to The primary endpoint, a composite of presence of lip ulcer, endotracheal tube dislodgement, ventilator-associated pneumonia, or facial skin tears from the time of randomization to the earlier of death or 48h after extubation, 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). examined the force required to extubate endotracheal tubes from cadavers with either tape or endotracheal tube fastener [5]. hbbd```b``` b+` D2i`&:`v4!$k/iR`L, 3` Od 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. For obvious reasons, the trial was open-label and not blinded, with investigators and clinical personnel aware of the allocation group. All analyses were conducted using SPSS version 25 (IBM SPSS Statistics for Windows, Version 25.0. All hypothesis tests were two-sided, with an of 0.05 unless otherwise specified. Univariate analysis demonstrated an OR of 2.33 (95% CI 1.134.83; p=0.022) for the development of the composite endpoint when adhesive tape compared to tube fastener was used for endotracheal tube securement. 2022 BioMed Central Ltd unless otherwise stated. 1998;27(6):40917. One of the tube dislodgements was a self-extubation in 2 patients in each group. Privacy statement and This trial also has several strengths. hZmo+C._\sksX-^}+zer\r8rgKiJ$4Z#V e. In the current trial, the use of a tube fastener resulted in 7.2% fewer patients developing complications compared to adhesive tape. The pragmatic nature of the trial allows for the enrollment of a heterogeneous population of consecutive critically ill patients, and the pragmatic design, without artificially regulating routine endotracheal tube position changes, reflects actual clinical practice, rendering the results more generalizable to the care of critically ill patients in general. The most common indication for intubation among both groups was respiratory failure (45.7% versus 53.1%, respectively). To account for the loss of patients not ventilated for 24h and a 5.6% dropout or loss to follow-up rate, we planned to enroll 500 patients to achieve the 284 eligible patients needed for the study. 2005;18(4):15865. 2). Simpson GD, Ross MJ, McKeown DW, Ray DC. These results suggest that the use of an endotracheal tube fastener rather than adhesive tape will result in fewer lip ulcers, endotracheal tube dislodgements, and facial skin tears. Anne G, Hughes D, Cook R, Henson R, et al. Hospital mortality was also similar between the 2 groups with 57 patients (37.3%) in the tube fastener group and 54 (37.2%) in the adhesive tape group dying prior to hospital discharge (p=0.99). Patients were randomized to endotracheal tube holder or tape in a 1:1 ratio using random permuted computer-generated blocks of 2, 4, and 6. In 2007, Carlson et al. Best practice in stabilization of oral endotracheal tubes: a systematic review. Due to the differences in age in baseline demographics, a post hoc ordinal regression was undertaken with age and randomization group as independent variables and rate of composite endpoint per 1000 ventilator days as the dependent variable. This study demonstrated that endotracheal tube fasteners reduced the incidence of lip ulcers, skin tears, and tube dislodgement compared to adhesive tape. Armonk, NY). The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial, https://doi.org/10.1186/s13054-019-2440-7, for the Pragmatic Critical Care Research Group, http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/. 1249 0 obj <>stream Are you sure you want to clear this supply list? For both groups, oral hygiene was performed every 12h and oral moistening every 2h based on ICU policy. Crit Care Nurs Q. We estimated the expected incidences of tube dislodgement and lip ulcer development to be 20 and 1.1 per 1000 ventilator days, respectively, based on the data from the previous 12months. 2015;64:18396. It is the first large, pragmatic, randomized trial of different endotracheal tube securement techniques focusing on the complications throughout the duration of mechanical ventilation and clinical outcomes during the ICU stay. The study protocol has been reviewed by the Institutional Review Board (IRB) Health Science Committee 1 at Vanderbilt University, and the need for informed consent from the patients was waived with a participant notification sheet (#170596). Due to the pragmatic nature of the trial, no additional data were collected that were not observed at the bedside or obtained from the medical record. Several techniques are utilized in current clinical practice to secure the endotracheal tube [2], in order to maintain a patent airway and prevent complications. Failure to evaluate the performance of the securement technique beyond 2h limits the interpretation of these data into critical care environments where the average duration of mechanical ventilation is measured in days or weeks. Prior studies investigating different endotracheal securement techniques are not generalizable to patients mechanically ventilated in an ICU.

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