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


Journal

Critical care (London, England)
ISSN: 1466-609X
Titre abrégé: Crit Care
Pays: England
ID NLM: 9801902

Informations de publication

Date de publication:
07 05 2019
Historique:
received: 19 12 2018
accepted: 15 04 2019
entrez: 9 5 2019
pubmed: 9 5 2019
medline: 20 12 2019
Statut: epublish

Résumé

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. 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. 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. 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. ClinicalTrials.gov NCT03760510. Retrospectively registered on November 30, 2018.

Sections du résumé

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.

Identifiants

pubmed: 31064406
doi: 10.1186/s13054-019-2440-7
pii: 10.1186/s13054-019-2440-7
pmc: PMC6505126
doi:

Banques de données

ClinicalTrials.gov
['NCT03760510']

Types de publication

Journal Article Pragmatic Clinical Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

161

Subventions

Organisme : NCATS NIH HHS
ID : UL1TR002243
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000445
Pays : United States

Investigateurs

David R Janz (DR)

Références

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pubmed: 2161310
Crit Care Nurs Q. 2012 Jul-Sep;35(3):247-54
pubmed: 22668998
Ann Emerg Med. 2007 Dec;50(6):686-91
pubmed: 17599694
Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903
pubmed: 11934711
Br J Anaesth. 2012 May;108(5):792-9
pubmed: 22315326
Heart Lung. 1998 Nov-Dec;27(6):409-17
pubmed: 9835671
Respir Care. 2011 Nov;56(11):1825-9
pubmed: 21605477
Aust Crit Care. 2005 Nov;18(4):158, 160-5
pubmed: 18038537

Auteurs

Janna S Landsperger (JS)

Department of Medicine, Vanderbilt University, T-1218 Medical Center North, Nashville, TN, 37232-2650, USA. janna.landsperger@vumc.org.
T-1218 Medical Center North, Vanderbilt University, Nashville, TN, 37232-2650, USA. janna.landsperger@vumc.org.

Jesse M Byram (JM)

Department of Medicine, Vanderbilt University, T-1218 Medical Center North, Nashville, TN, 37232-2650, USA.

Bradley D Lloyd (BD)

Department of Respiratory Therapy, Vanderbilt University, T-1218 Medical Center North Nashville, Nashville, TN, 37232-2650, USA.

Todd W Rice (TW)

Department of Medicine, Vanderbilt University, T-1218 Medical Center North, Nashville, TN, 37232-2650, USA.

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