VUMC to study the effect of breathing tube size on breathing, speaking, swallowing

Vanderbilt University Medical Center has been approved for $7 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to study the effect of breathing tube size on breathing, speaking and swallowing after critical illness.

Approximately 1% of the U.S. population — 2 to 3 million adults — experience critical illness requiring the placement of a breathing tube each year. Although 60% to 80% of patients survive, about half of those patients experience injury to the voice box from the breathing tube. These injuries may progress to scars that permanently impair the patients’ ability to breathe, speak and swallow.

Current recommendations regarding the appropriate breathing tube size for critically ill patients vary widely.

“Multiple recent systematic reviews have called for research examining the effect of breathing tube size on clinical outcomes,” said Jonathan Casey, MD, assistant professor of Medicine in the Division of Allergy, Pulmonary and Critical Care Medicine, and co-principal investigator of the study along with Alexander Gelbard, MD, professor of Otolaryngology-Head and Neck Surgery.

The preliminary work on the connection between breathing tube size and voice box injury was led by Gelbard.

“Otolaryngologists care for patients that survive critical illness but are left with impairments in breathing, speaking and swallowing caused by voice box injuries from a breathing tube. As a medical community, we have begun to advocate for the consistent use of smaller breathing tubes to prevent voice box injuries,” Gelbard said.

“Specialists who place breathing tubes in the hospital (emergency medicine, anesthesiology and critical care clinicians) have expressed concerns that smaller breathing tubes might keep patients on a breathing machine longer or even make them less likely to survive, and the lack of randomized trials comparing smaller vs. larger breathing tubes has led to significant variability in the breathing tube size clinicians use,” Casey said.

The Tube Size Randomized Trial during Emergency Tracheal Intubation (BREATHE) trial, will compare smaller vs. larger breathing tubes among 3,180 patients undergoing breathing tube placement in seven emergency departments and ICUs with these aims:

· Compare the effectiveness of smaller vs. larger breathing tubes on the long-term patient-centered outcomes of breathing, speaking and swallowing.

· Compare the safety of smaller vs. larger breathing tubes with regard to time spent on a breathing tube and survival.

The trial is being conducted by the Pragmatic Critical Care Research Group, which has enrolled more than 6,000 patients in 10 prior trials of emergency breathing tube placement, the North American Airway Collaborative, which has assessed long-term patient-centered outcomes for more than 1,000 patients with airway disease, and VUMC’s Critical Illness, Brain Dysfunction and Survivorship Center, which has enrolled more than 3,000 patients in landmark studies of long-term outcomes of critical illness.

“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders, but also for its conduct in real-world settings. It has the potential to answer an important question about the effect of breathing tube size on shortness of breath after critical illness and fill a crucial evidence gap,” said PCORI Executive Director Nakela Cook, MD, MPH. “We look forward to following the study’s progress and working with Vanderbilt University Medical Center to share its results.”

PCORI is an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers and clinicians with the evidence-based information they need to make better-informed health and health care decisions.