SurgeryNCT03220906
Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia
An observational study of Surgery, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Surgery
- What is being tested?
- Blood pressure measurement
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 2 Jul 2018
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing a surgical procedure with planned arterial cannula placement at Nationwide Children's Hospital in Columbus, OH or King Fahad Medical City in Riyadh, Saudi Arabia.
Who may be able to join
- ASA status 1-3
- 0-10 years of age
- Undergoing surgical procedure with planned arterial cannula placement
Who cannot join
- ASA status >3
- Older than 10 years of age
- Patient unable to have BP taken on 1 upper and 1 lower extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.
- Conditions
- Surgery
- Being tested
- Blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementOther
Blood pressure will be measured in both upper and lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| Arterial line | Children undergoing surgical procedure with planned arterial cannula placement. Receives: Other: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation >5 mmHg in MAP
Deviation >5 mmHg in MAP between one of the non-invasive measurements compared to invasive BP measurement at any point during the study.
Measured: 45 minutes
Secondary outcomes (1)
Deviation >10 mmHg
Deviation >10 mmHg between the non-invasive and invasive measurements.
Measured: 45 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 2017
- Study start21 Aug 2017
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahad Medical City
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220906
- Sponsor's protocol ID
- IRB17-00268
- Status last verified
- Aug 2018
- First submitted
- 14 Jul 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03220906
- Acronym / sponsor ID
- IRB17-00268
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- King Fahad Medical City
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 18 Jul 2017 (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.
There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterial line | – | Other: Blood pressure measurementChildren undergoing surgical procedure with planned arterial cannula placement. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing a surgical procedure with planned arterial cannula placement at Nationwide Children's Hospital in Columbus, OH or King Fahad Medical City in Riyadh, Saudi Arabia.
Key inclusion criteria (3 listed)
- ASA status 1-3
- 0-10 years of age
- Undergoing surgical procedure with planned arterial cannula placement
Key exclusion criteria (3 listed)
- ASA status >3
- Older than 10 years of age
- Patient unable to have BP taken on 1 upper and 1 lower extremity
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 |
|---|---|---|
| Blood pressure measurementBlood pressure will be measured in both upper and lower extremities. | Other | Arterial line |
Primary outcome
Deviation >5 mmHg in MAP
Time frame: 45 minutes
Deviation >5 mmHg in MAP between one of the non-invasive measurements compared to invasive BP measurement at any point during the study.
1 secondary outcome
Deviation >10 mmHg
Time frame: 45 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 31 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery, run by Nationwide Children's Hospital 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 3 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 31 Aug 2018. 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?
Deviation >5 mmHg in MAP (time frame: 45 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 31 Aug 2018.