- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01785030
Nitrous Oxide Vasodilation Healthy Adult Volunteers
Peripheral Vasodilation in Healthy Adult Volunteers Receiving 50% Nitrous Oxide
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- NewYork Presbyterian Morgan Stanley Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adult volunteers.
- 19 years or older (inclusive)
- English speaking.
Exclusion Criteria:
- ASA class III or greater;
- History of, or suspected, difficult airway based on physical exam, facial dysmorphism or syndrome
- Any condition in which air may be trapped in a body cavity. These include, but are not limited to:
Pneumothorax or chest injury, concurrent acute asthma exacerbation, middle ear occlusion, intestinal obstruction, ileus, or abdominal distension, sinusitis or maxillofacial injuries with potential for trapped gas, recent intraocular surgery or penetrating globe injury, air embolus, severe bullous emphysema (consider in patients with cystic fibrosis), history of craniotomy in previous three weeks
- Pregnancy (1st and 2nd trimester)
- Increased intracranial pressure, impaired level of consciousness, or head injury
- Known Vitamin B12 deficiency
- Known MTHFR Deficiency (Inborn error of metabolism)
- History of bleomycin administration (note that the oxygen component of N2O administration is what interacts with bleomycin to cause pulmonary toxicity)
- Intoxication with alcohol or other drugs
- Any condition in which patient may be catecholamine-depleted (e.g. septic shock)
- Recent history of altered mental status
- Pulmonary hypertension
- Congestive heart failure.
- Trainees, including students, residents, and fellows, working in the pediatric emergency department.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 50% Nitrous oxide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diameter of peripheral vein (mm)
Time Frame: 15-30 minutes at time of enrolment
|
15-30 minutes at time of enrolment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAK2807
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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