ETCare: a randomized, controlled, masked trial comparing two solutions for upper airway care in the NICU.
Christensen. R D RD; Rigby. G G; Schmutz. N N; Lambert. D K DK; Wiedmeier. S E SE; Burnett. J J; Scoffield. S H SH; Muelleck. R R; Snow. K K; Woodhead. D D DD; Snow. G L GL
Key Findings
- ETCare and normal saline were tolerated equally by intubated NICU babies.
- There was a trend toward fewer positive blood cultures in the ETCare group (OR 0.48, wide confidence interval).
- Fewer babies in the ETCare group were discharged needing supplemental oxygen (OR 0.43, trend level).
Practical Outcomes
- For clinicians, ETCare appears safe and may offer a modest benefit in reducing infections and chronic lung issues in ventilated newborns, but larger trials are needed. For biohackers, the main takeaway is that low‑sodium airway solutions could preserve LL‑37 activity, suggesting that minimizing salt exposure might be worth exploring in other airway health contexts.
Summary
A new low‑salt solution called ETCare was tested in newborns on ventilators and was found to be just as well tolerated as regular saline. It may help keep the natural antimicrobial peptide LL‑37 active in the airway, which could lower infection risk, but the study was small and only showed trends, not definitive proof.
Abstract
Small quantities of normal saline are sometimes instilled into the endotracheal tube of intubated neonates, to assist with the removal of thick secretions and maintain patency of the endotracheal tube. However, saline is detrimental to the innate immune system of the upper airway mucosa, rapidly unfolding and inactivating antimicrobial peptides such as LL-37. We previously reported the preparation and feasibility testing of 'ETCare', a low-sodium, physiologically based solution for airway care, and we now report results of a randomized, masked, controlled, two-centered study testing ETCare vs sterile saline among 60 intubated NICU patients. Sixty intubated NICU patients were randomized to having their airway care with ETCare vs saline. Three hypotheses were tested: (1) tolerance - patients will tolerate ETCare for airway care as well as they tolerate saline, (2) nosocomial infections - ETCare will result in fewer tracheal aspirates where organisms grow and fewer cases of nosocomial sepsis, and (3) chronic lung disuse - ETCare will result in fewer patients discharged home on supplemental O2. Thirty NICU patients with an endotracheal tube in place were randomized to receive their airway care with ETCare, and 30 to receive their care with saline. Only the pharmacist was aware of the randomization; the two solutions were visually indistinguishable and were dispensed in identical syringes. Tolerance of the solutions was similar. The ETCare recipients had trends toward fewer positive blood cultures (odds ratios (OR), 0.48; 95% confidence interval (CI), 0.13 to 1.68), and fewer discharges home on supplemental O2 (OR, 0.43; 95% CI, 0.14 to 1.32; P=0.075). On the basis of this study and our previous 10-patient feasibility trial, we maintain that, for airway care, intubated NICU patients tolerate ETCare as well as saline. Data from this study can be used in estimating the sample sizes needed for a phase III trial. We speculate that such a trial will demonstrate that, compared with saline, ETCare will result in fewer nosocomial infections and less chronic lung disease.
Study Information
pubmed
2007
2007-06-14T00:00:00.000Z
10.1038/sj.jp.7211779
2
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