2005 OPEN FORUM Abstracts
PHASE I FEASIBILITY AND PRELIMINARY SAFETY STUDY OF A NEW PHYSIOLOGICALLY BASED SOLUTION FOR UPPER AIRWAY CARE.
Daniel D. Woodhead RRT, Diane Lambert RN, Scott Scoffield RPH, Gregory Snow PhD,
Robert D. Christensen MD. Intermountain Health Care and the McKay-Dee Hospital Center, 4403 Harrison Blvd, Ogden, UT 84403.
Background. In patients with an endotracheal tube in place, sterile saline is sometimes periodically instilled as part of routine suctioning. However, a series of recent studies show that normal saline (0.9% sodium chloride) can inactivate important natural antimicrobial peptides in upper airway secretions. Thus, instilling saline into the trachea might unwittingly diminish innate immunity in the upper airway. Therefore, we produced a solution for tracheal irrigation that is based on the constituents of normal unstimulated airway secretions (Table), and we assessed the feasibility and safety of periodically instilling this new solution for airway care, in place of sterile saline.
Methods. In a phase I open-labeled feasibility trial, 5 intubated neonates in the McKay-Dee NICU were to receive the new solution exclusively, rather than saline, for airway care. Feasibility was judged by the respiratory therapists and bedside nurses who performed the airway care. Signs of immediate intolerance with the new solution were recorded on a bedside checklist, and laboratory tests were compared with an historic cohort of all intubated neonates in this NICU during the years 2003 and 2004.
Results. With IRB approval and parental consent, 5 patients were treated with the test solution rather than saline. All 5 received each treatment as planned. No problems with feasibility of administration, or immediate intolerance, were observed in any. During 2003 and 2004, 479 neonates were intubated for mechanical ventilation in our NICU, of which 469 (98%) survived to discharge home. Laboratory tests on these 479 were compared with those from the study subjects, to assess whether the new solution might have resulted in abnormalities in hepatic, renal, or hematologic values. The laboratory values of the study subjects were not outside the range predicted by cohort analysis.
Conclusions. It was feasible to administer the test solution as planned, and the solution was well tolerated with no observed short-term adverse effects. A phase II, randomized, controlled, multicentered, safety and preliminary efficacy trial is now underway to test whether this new solution reduces airway colonization with pathogens, and reduces airway inflammation.
Table. The constituents of the standard solution used for periodic upper airway care
(0.9% NaCl), are compared with normal unstimulated neonatal saliva (mean±SD), and with the physiologically-based test solution we produced.
|Na (mEq/L)||K (mEq/L)||Cl (mEq/L)||Ca (mEq/L)||Mg (mEq/L)||PO4 (mEq/L)||Protein (mg/dL)|