Nitrous Oxide Vasodilation Healthy Adult Volunteers

NCT ID: NCT01785030

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-02-28

Brief Summary

Nitrous oxide (N2O) is a gas that is normally used to take away pain and anxiety during painful medical procedures. However, one of its effects is to also make veins appear larger and more visible. This is useful when there is a patient who needs to have an intravenous (IV) needle put in their skin to give them medicine or fluids, but may have veins that are very hard to see or feel. The mechanism of this observed effect is not entirely clear. The purpose of this study is to use an ultrasound to directly measure whether there is an actual change size of veins or change in blood flow in healthy adult volunteers when you give them 50% nitrous oxide, and see whether or not this change in size, or change in flow, is what causes the changes in visibility or palpability of the vein.

Conditions

Peripheral Vein Vasodilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

50% Nitrous oxide

Group Type: EXPERIMENTAL

50% Nitrous oxide

Intervention Type: DRUG

Interventions

50% Nitrous oxide

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Daniel S Tsze, MD, MPH

Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S Tsze, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

NewYork Presbyterian Morgan Stanley Children's Hospital

New York, New York, United States

Countries

United States

Other Identifiers

AAAK2807

Identifier Type: -

Identifier Source: org_study_id