Difficult Intravenous AccessNCT03591016
Prospective Observational Study of Difficult Intravenous Access in the Operating Room
An observational study of Difficult Intravenous Access, run by Ralph Beltran at 1 site in United States.
Trial summary
This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Difficult Intravenous Access
- What is being tested?
- Recording number of IV attempts
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 8 Dec 2020
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female 0-18 years old undergoing surgery with anesthesia requiring an IV.
Who may be able to join
- Patients 0-18 years of age
- Having surgery at Nationwide Children's Hospital
Who cannot join
- Pre-existing IV upon arrival to the operating room
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.
- Conditions
- Difficult Intravenous Access
- Being tested
- Recording number of IV attempts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording number of IV attemptsOther
Recording number of IV attempts in the operating room
| Study group | Role | What they receive |
|---|---|---|
| Difficult intravenous access | Recording number of IV attempts in the operating room prior to surgery start. Receives: Other: Recording number of IV attempts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time it takes to insert an IV
Measured: between 1 to 30 minutes
Secondary outcomes (2)
Anticipated difficulty
Provider's prediction of how difficult it will be to start the IV on a Likert scale of 1-10, with 10 being the most difficult.
Measured: Baseline
Actual difficulty
Provider's assessment of how difficult the actual IV insertion was on the same Likert scale.
Measured: between 1 to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start2 Jul 2018
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Intravenous AccessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ralph Beltran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ralph Beltran, Nationwide Children's Hospital
- Investigators
- Ralph Beltran, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591016
- Sponsor's protocol ID
- IRB18-00495
- Status last verified
- Feb 2021
- First submitted
- 20 Jun 2018
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Difficult Intravenous Access in the Operating Room
- ClinicalTrials.gov ID
- NCT03591016
- Acronym / sponsor ID
- IRB18-00495
- Conditions
- Difficult Intravenous Access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Ralph BeltranUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- 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.
This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Difficult intravenous access | – | Other: Recording number of IV attemptsRecording number of IV attempts in the operating room prior to surgery start. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female 0-18 years old undergoing surgery with anesthesia requiring an IV.
Key inclusion criteria (2 listed)
- Patients 0-18 years of age
- Having surgery at Nationwide Children's Hospital
Key exclusion criteria (1 listed)
- Pre-existing IV upon arrival to the operating room
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 |
|---|---|---|
| Recording number of IV attemptsRecording number of IV attempts in the operating room | Other | Difficult intravenous access |
Primary outcome
Time it takes to insert an IV
Time frame: between 1 to 30 minutes
2 secondary outcomes
Anticipated difficulty
Time frame: Baseline
Actual difficulty
Time frame: between 1 to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
Related trials for Difficult Intravenous Access
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Active, not recruitingObservational study
A New Landmark-formula for Cephalic Vein in Children
Venipuncture, Ultrasound
Not yet recruiting
Ultra-Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult IV Access Patients
Difficult Intravenous Access, Adults
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.
Ralph Beltran, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Intravenous Access, run by Ralph Beltran 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 15 Feb 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time it takes to insert an IV (time frame: between 1 to 30 minutes). 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 15 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.