Nitric Oxide Administration for Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal of the study is to evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.

Detailed Description
-----------------
At low concentrations, nitric oxide(NO) functions as a cellular messenger and regulator of microcirculation. NO may have an important role in the pathogenesis of ARDS as well as its treatment. NO may be primarily useful in improving matching of ventilation and perfusion in the lung. The aims of the study are to attempt to show that NO will improve oxygenation as evidenced by improvement in PaO2/FiO2. Secondary aims are to see if the improvement in oxygenation allows there to be decreased time on FiO2>0.60, evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not. Subjects will be randomized to receive either nitric oxide first (nitric oxide for the first 4 hours, then no intervention/no nitric oxide for the next 4 hours) or delayed treatment with nitric oxide (no intervention/no nitric oxide for the first 4 hours, then nitric oxide for the next 4 hours).. Blood gases were monitored once an hour during study participation (total of 8 hours). Final PaO2/FiO2 levels will be compared after 8 hours of study treatment in each group.

Official Title
-----------------
Nitric Oxide Administration for Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Drug: Nitric Oxide
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is intubated and mechanically ventilated in the Pediatric Intensive Care Unit with a PaO2/FiO2 ratio less than or equal to 100, FiO2 greater than or equal to 0.60, PEEP greater than or equal to 10, and a Murray score greater than or equal to 2.5. Exclusion Criteria: Neonates (1 week to 28 days) and/or patients on extracorporeal membrane oxygenation

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitric oxide first<br>Subjects will be randomized to receive Nitric Oxide (NO) immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide (NO) will be turned off and subjects will receive no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects will receive standard clinical are. Blood gases will be monitored once an hour for 4 hours. | Drug: Nitric Oxide<br>* Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.<br>* Other names: Inhaled Nitric Oxide;Other: No Intervention<br>* Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.<br>|
| Active Comparator: Delayed nitric oxide<br>Subjects will be randomized to receive no intervention (no nitric oxide) for he first 4 hours of study participation. During this time, all subjects will receive standard clinical care. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide will be turned on and subjects will receive 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours. | Drug: Nitric Oxide<br>* Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.<br>* Other names: Inhaled Nitric Oxide;Other: No Intervention<br>* Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean PaO2/FiO2 Ratio | Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Acute Respiratory Distress Syndrome, Nitric Oxide