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Inhaled Nitric Oxide in Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03260569
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Goodman, University of Cincinnati

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Inhaled Nitric Oxide Drug: Placebo Phase 3

Detailed Description:

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:

  1. redistribution in regional perfusion, which is partially mediated by the hypothalamus
  2. pulmonary microembolism, leading to increased dead space
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Following initial non-invasive measurements, patients will be randomized to either an active treatment (inhaled nitric oxide at 30 parts per million) or placebo (nitrogen only). After two hours, measurements will be reassessed. If the patient remains on the mechanical ventilator at 72 hours post-admission, a third set of non-invasive measurements will be taken.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Both nitric oxide and placebo nitrogen will be made available in unmarked cylinders.
Primary Purpose: Treatment
Official Title: Respiratory Mechanics Following Brain Injury: The Role of Inhaled Nitric Oxide
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Inhaled Nitric Oxide
Inhaled nitric oxide at 20 parts per million, administered once during first 36 hours following admission
Drug: Inhaled Nitric Oxide
Patients randomized to this arm will receive inhaled nitric oxide 20 parts per million.

Placebo Comparator: Placebo
Nitrogen only, administered once during first 36 hours following admission
Drug: Placebo
Nitrogen plus oxygen




Primary Outcome Measures :
  1. Change in PaO2 [ Time Frame: Randomization through Day 3 of the study ]
    The primary endpoint is a change in PaO2 of 20 percent or greater (yes/no)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260569


Contacts
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Contact: Michael D Goodman, MD 513-558-5661 goodmanmd@uc.edu

Locations
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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Carolina Rodriguez         
Sponsors and Collaborators
University of Cincinnati

Publications:

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Responsible Party: Michael Goodman, Instructor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03260569    
Other Study ID Numbers: 2017 Goodman
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Michael Goodman, University of Cincinnati:
Mechanical ventilation
Inhaled nitric oxide
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents