The importance of clinical trial participation through the lens of Pulmonary/Critical Care

Findings from clinical trial research conducted at Ochsner Health were recently featured in the Journal of the American Medical Association. Derek J. Vonderhaar, M.D., Associate Research Medical Director- Pulmonary/Critical Care for Ochsner Health and Clinical Assistant Professor- Emergency Medicine for LSU School of Medicine- New Orleans, was a contributing author to the article, “Effect of Fluid Bolus Administration on Cardiovascular Collapse Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial.”

The JAMA study was a continuation of research featured in The Lancet in 2019, investigating patient outcomes during emergency tracheal intubations. The randomized clinical trial enrolled 1067 critically ill adults undergoing tracheal intubation with sedation and positive pressure ventilation at 11 intensive care units in the US, including Ochsner Health facilities, between February 1, 2019, and May 24, 2021.

“Many providers believe that fluid bolus – that is, a rapid infusion of intravenous fluids — at the time of intubation improves hypotension and prevents cardiovascular collapse, but we had limited data to support this practice so it was ultimately utilized based on provider preference,” explained Vonderhaar. “Our first trial demonstrated that there was no overall benefit to using a routine fluid bolus to improve outcomes during intubation.”

Subgroup analysis in that first trial suggested that patients receiving positive pressure (non-invasive pressure via mask or bag valve mask at time of intubation) might have better outcomes. The research in JAMA focused specifically on enrolling patients that were receiving positive pressure and randomized to a fluid bolus or none. Again, fluid boluses did not improve outcomes.

“Based on these two large trials, it is reasonable to conclude that routine use of fluid boluses during intubation is not beneficial for patients, and ultimately spares them from unnecessary interventions,” said Vonderhaar.

For over seven years, Ochsner has been part of the Pragmatic Critical Care Research Group (PCCRG), a network of committed critical care physicians across the country who maintain a focus on obtaining high quality evidence to improve care practices and outcomes in our sickest and most vulnerable patient populations. During this period, Ochsner has enrolled and contributed to six clinical trials, all resulting in publication in high impact journals.

Participation in clinical trials such as these is vital to the important ongoing work of refining critical care protocols and procedures.

“Patient enrollment into these trials is a group effort in our department as we all seek to provide the best evidenced based care possible,” says Vonderhaar. “My hope moving forward is that we continue to grow pulmonary and critical care research here at Ochsner. Increased research involvement ensures that we remain at the forefront of medicine and allows us to offer our patients increasing opportunities and access to new treatments and therapies.”