Peripheral Vein VasodilationPhase 1NCT01785030
Nitrous Oxide Vasodilation Healthy Adult Volunteers
A Phase 1 study testing 50% Nitrous oxide in people with Peripheral Vein Vasodilation, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral Vein Vasodilation
- What is being tested?
- 50% Nitrous oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers.
- 19 years or older (inclusive)
- English speaking.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
Official title: Peripheral Vasodilation in Healthy Adult Volunteers Receiving 50% Nitrous Oxide
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
- Being tested
- 50% Nitrous oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% Nitrous oxideDrug
| Study group | Role | What they receive |
|---|---|---|
| 50% Nitrous oxide | Experimental | Not described Receives: Drug: 50% Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of peripheral vein (mm)
Measured: 15-30 minutes at time of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vein VasodilationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S Tsze, MD, MPH, Columbia University
- Investigators
- Daniel S Tsze, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785030
- Sponsor's protocol ID
- AAAK2807
- Status last verified
- Jan 2019
- First submitted
- 1 Feb 2013
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Vasodilation in Healthy Adult Volunteers Receiving 50% Nitrous Oxide
- ClinicalTrials.gov ID
- NCT01785030
- Acronym / sponsor ID
- AAAK2807
- Conditions
- Peripheral Vein Vasodilation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50% Nitrous oxide | Experimental | Drug: 50% Nitrous oxide |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult volunteers.
- 19 years or older (inclusive)
- English speaking.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50% Nitrous oxide | Drug | 50% Nitrous oxide |
Primary outcome
Diameter of peripheral vein (mm)
Time frame: 15-30 minutes at time of enrolment
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Tsze, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50% Nitrous oxide in people with Peripheral Vein Vasodilation, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of peripheral vein (mm) (time frame: 15-30 minutes at time of enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.