Inhaled Nitric Oxide in Brain Injury
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|ClinicalTrials.gov Identifier: NCT03260569|
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Inhaled Nitric Oxide Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|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.|
|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, 2021|
|Estimated Study Completion Date :||October 1, 2021|
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
Nitrogen plus oxygen
- 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)
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
|Contact: Michael D Goodman, MDfirstname.lastname@example.org|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Carolina Rodriguez|