Journal: Chest
PMID: 32882244

Journal: BMC Nephrology
PMID: 33546622

Journal: Journal of Intensive Care Medicine
PMID: 33016193

Journal: Journal of Emergency and Critical Care Medicine
PMID: 34179689

Journal: Journal of Intensive Care Medicine
PMID: 30630380

Patients being treated for sepsis, a serious infection that can lower blood pressure, are often treated with fluids through an IV. Previous studies have shown that a positive fluid balance, or more fluids taken in than out, may be connected to problems with kidney and lung function. The BALANCE pilot trial enrolled 30 patients; 15 patients received fluid in a conservative and restrictive manner, and 15 patients were given the typical fluid care. Results showed that the conservative fluid approach did not decrease fluid balance for patients with sepsis.  These findings suggest that future research on fluid treatment for sepsis will need to find ways to achieve bigger differences in the amount of fluid being received between the approaches being examined.

Rationale: The feasibility and clinical outcomes of conservative fluid management after sepsis resuscitation remain unknown.

Objectives: To evaluate the effect of a conservative fluid management protocol on fluid balance and intensive care unit (ICU)-free days among patients with sepsis.

Methods: In a single-center phase II/III randomized trial, we enrolled adults with suspected infection, ≥2 systemic inflammatory response syndrome criteria, and either shock (mean arterial pressure <60 mm Hg or vasopressors) or respiratory insufficiency (mechanical ventilation or oxygen saturation <97% and fraction of inspired oxygen ≥0.3). Patients were randomized 1:1 to usual care or a conservative fluid management protocol. The protocol restricted intravenous fluid administration during shock to treatment of oliguria or increasing vasopressor requirement. In the absence of shock, loop diuretic infusion targeted equal fluid input and output each study day. The primary outcomes were mean daily fluid balance (phase II) and ICU-free days (phase III).

Results: At the completion of phase II (n = 30), the difference in mean daily fluid balance between groups (-398 mL) was less than the prespecified threshold (-500 mL) and the trial was stopped. Patients in the conservative fluid management (n = 15) and usual care (n = 15) groups experienced similar cumulative fluid input (8450 mL vs 7049 mL; P = .90) of which only 14% was intravenous crystalloid or colloid. Loop diuretic infusion occurred more frequently in the conservative fluid management group (40% vs 0%; P = .02), and cumulative fluid output was 10 645 mL in the conservative fluid management group compared to 6286 mL in the usual care group (P = .39). Hemodynamic, respiratory, and renal function did not differ between the groups.

Conclusions: In this phase II trial, a conservative fluid management protocol did not decrease mean daily fluid balance by more than 500 mL among patients with sepsis.

Registration: Clinicaltrials.gov; NCT02159079.

Keywords: acute kidney injury; intravenous fluid; sepsis.

Conflict of interest statement

CONFLICTS OF INTEREST

All authors completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors declared no potential conflicts of interest with the current work. W.H.S. reported serving on advisory boards for Venaxis, Inc., Ferring Pharmaceuticals, and Cempra Pharmaceuticals, and as a consultant for Abbott Point-of-Care. T.W.R. reported serving on an advisory board for Avisa Pharma, LLC and as the Director of Medical Affairs for Cumberland Pharmaceuticals, Inc.

Manuscript Title: “Conservative Fluid Management After Sepsis Resuscitation: A Pilot Randomized Trial.”

Journal: Journal of Intensive Care Medicine

PMID: 30630380

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 32749864

Journal: JAMA Network Open
PMID: 33196806

Journal: Critical Care Explorations
PMID: 33196049

Journal: BMJ Open
PMID: 32948554

Journal: Annals of the American Thoracic Society
PMID: 32364753

Journal: Annals of the American Thoracic Society
PMID: 32364753

Journal: Journal of Medical Systems
PMID: 32737684

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 31972099

Journal: Chest
PMID: 32145801

Journal: Ann Pharmacotherapy
PMID: 31544471

Journal: Lancet Respiratory Medicine
PMID: 31585796

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 31454263

Journal: Critical Care Medicine
PMID: 31385881

Journal: Annals of the American Thoracic Society
PMID: 31038996

Journal: BMJ Open
PMID: 31377713

Journal: EClinical Medicine
PMID: 31517257

For patients on a breathing machine, doctors may secure the breathing tube in place using either adhesive tape or an endotracheal tube fastener.  The ETTS Trial compared the securement technique of adhesive tape versus an endotracheal tube fastener for patients in the medical intensive care unit expected to require a breathing machine for more than 24 hours. Safety and efficacy of the two techniques were compared by evaluating the presence of lip ulcers, the tube becoming dislodged from the patient, ventilator-associated pneumonia, or facial skin tears. Results of the study showed that the use of the endotracheal tube fastener reduced the rate of lip ulcers, tube dislodgement, and skin tears compared to the use of adhesive tape. The findings suggest that using an endotracheal tube fastener will reduce the rate of these events, may improve patient safety, and may decrease the cost of care.

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.

Keywords: Critical care; Endotracheal tube; Endotracheal tube dislodgement; Facial skin tear; Intensive care units; Lip ulcer; Mechanical ventilation; Tube fastener.

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

Journal: Critical Care

PMID: 31064406

Journal: Journal of Intensive Care Medicine
PMID: 29986619