Ethical issues of clinical trials for the pulmonary artery catheter.

Objective: To review the literature addressing ethical issues related to clinical research and the pulmonary artery catheter (PAC).

Data source: All pertinent English language articles dealing with ethical issues related to clinical research and the PAC were retrieved from 1970 through 1996.

Study selection: Articles were chosen for review if ethical issues related to clinical research and the PAC were studied or reviewed.

Data extraction: From the articles selected, information was obtained about the ethics of clinical research related to the PAC.

Data synthesis: Many current procedures and treatments used on a daily basis have not been proven effective by clinical trials. Studies showing increased mortality with the use of PACs are worrisome. Many clinicians have strong preferences about the use of PACs for various indications and there have been difficulties performing clinical trials. Clinical equipoise occurs when competent physicians are content to have their patients receive any of the various treatments in a randomized trial because, based on available data, none has proven preferable. Clinical equipoise for pulmonary artery catheterization for various indications is unknown. If >70% of experts determine that pulmonary artery catheterization is indicated or contraindicated for specific indications, clinical equipoise does not exist and a trial could not ethically be performed for these indications. Indications and contraindications for pulmonary artery catheterization for these indications, however, should be determined. Clinical equipoise would be present if <70% of experts favor pulmonary artery catheterization for a specific indication and trials could be performed in patients with these disorders.

Conclusion: Randomized clinical trails of pulmonary artery catheterization can ethically be conducted.