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Nitrous Oxide Vasodilation Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT01785030
Recruitment Status : Terminated (Poor enrollment)
First Posted : February 6, 2013
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel S Tsze, MD, MPH, Columbia University

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.

Condition or disease Intervention/treatment Phase
Peripheral Vein Vasodilation Drug: 50% Nitrous oxide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripheral Vasodilation in Healthy Adult Volunteers Receiving 50% Nitrous Oxide
Actual Study Start Date : February 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 50% Nitrous oxide Drug: 50% Nitrous oxide



Primary Outcome Measures :
  1. Diameter of peripheral vein (mm) [ Time Frame: 15-30 minutes at time of enrolment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT01785030


Locations
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United States, New York
NewYork Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Daniel S Tsze, MD, MPH Columbia University

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Responsible Party: Daniel S Tsze, MD, MPH, Assistant Professor of Clinical Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01785030     History of Changes
Other Study ID Numbers: AAAK2807
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents