Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Title: Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia – Prevent 2 Study

Principal Investigator: Miriam M. Treggiari, MD, PhD, MPH

Pneumonia is the most common infection acquired in the intensive care unit, particularly in patients requiring support from a breathing machine. Pneumonia occurring while on the breathing machine is called ventilator-associated pneumonia. This infection can lead to more time in the intensive care unit, and may lead to future health complications or even death. To allow the support of the breathing machine an endotracheal tube is inserted in the airway. One of the mechanisms leading to pneumonia is pooling of secretions in the back of the throat and leakage of these secretions past the endotracheal tube.

We are planning to conduct a clinical trial to determine if the use of a modified endotracheal tube equipped with a special port to allow suctioning of secretions reduces the incidence of ventilator-associated pneumonia. Additionally, the modified endotracheal tube is made of material that helps reduce leakage of secretions past the tube in the lower airway. Approximately 1,000 patients will be enrolled in this clinical trial. Patients requiring emergent endotracheal intubation will be assigned to receive either the study endotracheal tube or the standard endotracheal tube.

The objective of the trial is to determine if the study endotracheal tube reduces the occurrence of ventilator-associated pneumonia, and as a result, it improves long-term quality of life and mental abilities compared with the standard endotracheal tube. We will also evaluate the safety of the study endotracheal tube. The data from this clinical trial will help clinicians decide whether using the study endotracheal tube is better than the standard endotracheal in patients requiring emergent endotracheal intubation.

Clinical Trials Identifier: NCT03705286

Sponsor: Congressionally Directed Medical Research Program - US Army – Department of Defense

Title: Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury: TEMPLE

Principal Investigator: Miriam M. Treggiari, MD, PhD, MPH

Experiencing lower blood pressure is a common event following high spinal cord injury (SCI). Prevention of low blood pressure and early management in an Intensive Care Unit has saved lives and improved the functional results among survivors of SCI. When there is swelling of the spinal cord due to contusion, there is a window of opportunity to preserve some sections of the spinal cord near the level of injury, before they suffer irreversible damage. Today, it is unknown what blood pressure is optimal to help preserve these sections of the spinal cord at risk of ongoing damage. While it is known that managing blood pressure improves outcomes for patients, the best blood pressure range is not yet known. This study will provide guidance to care providers on how to manage blood pressure in the first week after the injury to achieve the best short- and long-term results to improve the life of victims of SCI.

The objective of this study is to determine if targeted blood pressure manipulation will improve patient outcomes, including neurological function, functional independence, pain levels, and quality of life after SCI.

The trial is a multi-center, randomized, controlled study designed to assess the efficacy and safety of early targeted blood pressure management (TPM) in an intensive care unit (ICU) setting in adult patients with acute spinal cord injury involving the cervical and thoracic spine. 

Clinical Trials Identifier: NCT02878850