Skip to main content
OpenTrials
Completed

NCT Number: NCT03260569

Inhaled Nitric Oxide in Brain Injury

This study will evaluate the changes in respiratory mechanics following traumatic brain injury and determine the effect of inhaled nitric oxide on gas exchange.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

Intubation and mechanical ventilation are common treatments in the care of patients with traumatic brain injury (TBI). Intubation allows for airway control and facilitates removal of respiratory secretions. Mechanical ventilation allows control of arterial carbon dioxide to aid in control of intracranial pressure. Recent evidence suggests that lung protective ventilation (tidal volumes of 6 ml/kg of predicted body weight and moderate positive end expiratory pressure) improves outcomes following brain injury and reduces brain-lung cross talk.

The treatment of respiratory failure in TBI must balance the need to improve lung function with the negative consequences of increased intrathoracic pressure on mean arterial pressure, intracranial pressure and venous return. Traditional treatment of increasing positive end expiratory (PEEP) and mean airway pressure then, represent competing interests. Methods for improving arterial oxygenation while avoiding negative hemodynamic effects are needed.

The impact of head injury on respiratory mechanics has been studied in just a few clinical investigations. (1-3) Of note, the earliest of these noted that the ventilation perfusion (V/Q) matching following TBI was not the result of lung collapse or parenchymal lung disease but secondary to alterations in perfusion. There are three possibilities for this finding:

  • redistribution in regional perfusion, which is partially mediated by the hypothalamus
  • pulmonary microembolism, leading to increased dead space
  • lung surfactant depletion due to excessive sympathetic stimulation and hyperventilation.

The introduction of inhaled pulmonary vasodilators such as inhaled nitric oxide or aerosolized epoprostenol offer an opportunity to improve oxygenation in patients with TBI without increasing airway pressures in the face of V/Q inequalities.

This study will evaluate the changes in respiratory mechanics following TBI and determine the effect of inhaled nitric oxide on gas exchange.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospital admission with traumatic brain injury (penetrating or blunt)
  • Requirement for mechanical ventilation
  • Glasgow Coma Score > 3

Exclusion criteria

  • Brain death
  • Expected survival < 48 hours
  • Air leak (bronchopleural fistula, tracheal injury)
  • Current inspired oxygen concentration (FiO2) > 0.65
  • Hemodynamic instability (systolic blood pressure < 100 mm Hg, cardiac arrhythmia)
  • Uncontrolled intracranial pressure (> 20 mm Hg)
  • Spinal cord injury with hypotension
  • Severe acute respiratory distress syndrome (ARDS) (PaO2/FiO2 < 100)
  • Chest abbreviated injury score (AIS) > 3
  • First rib fracture
  • Flail chest

Treatment and study plan

Inhaled Nitric Oxide

Drug

Patients randomized to this arm will receive inhaled nitric oxide 20 parts per million.

Placebo

Drug

Nitrogen plus oxygen

Primary outcomes

  1. PaO2

    Time frame: at Day 3 of the study

    The primary endpoint is the difference in PO2

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Respiratory Mechanics Following Brain Injury: The Role of Inhaled Nitric Oxide

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2017
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.