Inhaled Nitric Oxide in Brain Injury

December 28, 2023 updated by: Michael Goodman, University of Cincinnati

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael D Goodman, MD
  • Phone Number: 513-558-5661
  • Email: goodmanmd@uc.edu

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Randomization through Day 3 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

December 28, 2023

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 2, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017 Goodman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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