2001 OPEN FORUM Abstracts
INHALEDNITRIC OXIDE: ONE-YEAR EXPERIENCE WITH A PROTOCOL FOR APPROPRIATE USE.
DeanR. Hess PhD RRT FAARC, Daniel Chipman RRT, Robert M. Kacmarek PhD RRTFAARC, William E. Hurford MD. Massachusetts General Hospital and Harvard MedicalSchool.
Nitric oxide, whenadministered by inhalation, is a selective pulmonary vasodilator. Over the past10 years, there has been considerable academic and clinical interest in theuse or inhaled nitric oxide (iNO) in the treatment of diseases associated withpulmonary hypertension and hypoxemia. Randomized controlled trials have reportedbenefit for the use of iNO in the care of newborns with hypoxic respiratoryfailure, and the FDA approved the use of iNO for this indication on December23, 1999. However, randomized controlled trials to date have not shown a benefitfor iNO in other diseases, and its use in these cases is off-label. Given therelative lack of evidence for off-label use of iNO and the expense associatedwith this therapy, we designed an institution-approval protocol for the useof iNO in our hospital.
Methods: iNOfor patient use is controlled by our Innovative Devices and Therapeutics Committee.This committee approved the use of iNO for newborns and for selected off-labelindications. Off-label use was approved for the following indications: inhalationinjury ARDS, lung resection ARDS, severe ARDS considered for ECMO, heart orlung transplantation, and acute right ventricular failure. Under each off-labelindication, specific criteria were established for initiation of iNO therapy.Specific eligibility criteria were developed by consensus. If criteria to initiatetherapy are met, a 30-min to 1-hr trial is conducted, and a decision to continuetherapy is made based upon strict criteria. The use of iNO is monitored underthe auspices of a Phase IV observational study with IRB approval. The respiratorycare department was charged with screening all requests for iNO use, determiningeligibility based upon institution-approved criteria, dispensing the gas, monitoringall aspects of utilization, and maintaining a database on its use and efficacy.Every request for iNO is prospectively reviewed by one of the respiratory caremanagement team before therapy is initiated. Individual cases that fall outsideof eligibility criteria are mediated, as necessary, by the co-chairs of thecritical care committee.
Results: Forthe first year of this protocol (April 1, 2000, to April 1, 2001), 25 newbornsreceived iNO and all meet eligibility requirements. Eleven of these patientswere receiving iNO prior to transfer (in most cases to be considered for ECMO).Initiation of iNO increased PaO2 from a mean of 61 mm Hg to 154 mmHg. ECMO was avoided in 44% of these patients, the mean length of iNO therapywas 2.2 days, and survival was 95%. For off-label indications, iNO was usedin 47 patients (2 inhalation injury ARDS, 8 severe ARDS, 2 heart or lung transplantation,36 right ventricular failure, 1 sickle cell disease); 85% met eligibility requirements.For those that did not meet eligibility requirements, iNO was approved afterrespiratory care and physician mediation. Of 48 trials (2 trials for 1 patient),24 met criteria to continue therapy. In these trials, PaO2 increasedfrom 58 mm Hg to 101 mm Hg, and mean pulmonary artery pressure decreased from41 mm Hg to 36 mm Hg with iNO. For off-label indications, the mean durationof therapy was 2.4 days. No safety concerns have arisen. Total program costswere 62% below the budget estimate for the first year.
Conclusions:We have had excellent compliance with the protocol: 100% with neonatal use and85% with off-label use. This has resulted in appropriate and cost-effectiveuse of iNO in our hospital.