Proximal Humerus Interosseous Venous AccessNCT03121794
Ultrasonographic Identification of the Proximal Humerus Landmarks
An observational study of Proximal Humerus Interosseous Venous Access and Anatomic Landmark, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humerus Interosseous Venous Access, Anatomic Landmark, Ultrasonography
- What is being tested?
- Ultrasonographic exam and ultrasound machine
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 7 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected after chart review of current patients undergoing general, cardiac, thoracic, or vascular surgery. Patients will be approached in the preoperative clinic or during their hospitalization (preoperatively or postoperatively). Informed consent will be obtained prior to performing the study. Participants will be separated into 3 cohorts based on BMI. The number of participants in each cohort is as follows: 10 patients with BMI 18.5 - 25 kg/m2; 10 patients with BMI 30-35 kg/m2, 10 patients with BMI > 40 kg/m2.
Who may be able to join
- Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.
- BMI >= 18.5 kg/m^2
Who cannot join
- Limited mobility/ range of motion of arms
- Prior surgical intervention on shoulder or humerus
- History of arm dislocation with internal rotation
- History of arm fracture
- BMI in ranges: 25.1 - 29.9, 35.1 - 39.9
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Identification of the Proximal Humerus Landmarks for Intra-Osseous Vascular Access Across Different Body Habitus
Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.
Read the detailed description
There are three main forms of vascular access: peripheral intravenous (PIV), Central venous (CV) and intraosseous (IO). Of the different types of vascular access PIV and CV access have drawbacks when used during resuscitation, because they can be difficult to obtain when patients are volume depleted as in cases of trauma. Attempting CV access has numerous risks with complications occurring in up to 33% of attempts. These include failed placement (22%), arterial puncture (5%), catheter malposition (4%), pneumothorax (1%) and asystolic cardiac arrest (<1%). Attempting to obtain CV access may also disrupt chest compressions in cases of cardiac arrest. Intraosseous access has been used in scenarios where PIV and CV access is difficult or impossible to obtain. Pharmacokinetic studies and standard practice support the bioequivalence of intraosseous and intravenous administration of common medications. Intravascular depletion does not hinder attempts at IO access, and as the insertion sites are peripheral to the heart, insertion can be done avoiding interruptions in chest compressions. Obtaining proximal humerus interosseous (PHIO) access may also be faster than obtaining both PIV and CV access with a relatively low complication rate. In one survey, complications of IO included difficulty in identifying correct anatomical site (3%), extravasation (3.7%), displacement after insertion (8.5%), and very rarely late complications including compartment syndrome (0.6%), osteomyelitis (0.4%) and skin infection (0.3%).
- Being tested
- Ultrasonographic exam, ultrasound machine
- Keywords
- ultrasonography, Intraosseous Vascular access, humerus, anatomic landmark
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic examProcedure or surgery
The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
ultrasound machineDevice
Regular ultrasound machine used at Cleveland Clinic
| Study group | Role | What they receive |
|---|---|---|
| Low BMI | Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2 Receives: Procedure: Ultrasonographic exam; Device: ultrasound machine | |
| Moderate BMI | Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam. Receives: Procedure: Ultrasonographic exam; Device: ultrasound machine | |
| High BMI | Ultrasonographic identification of proximal humerus landmarks for patients with BMI > 40 kg/m2 will receive ultrasound exam. Receives: Procedure: Ultrasonographic exam; Device: ultrasound machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of proximal humerus landmarks successfully identified by ultrasound exam
Two investigators will perform an ultrasonographic exam on each patient, with one investigator examining each side of the body. Each investigator will aim to identify 6 anatomical landmarks:
- The humeral shaft,
- The surgical neck of the humerus,
- The lesser tubercle,
- The greater tubercle,
- The intertubercular sulcus
- The target site in the greater tubercle for needle insertion. Each side will receive a score ranging from 0 to 6 corresponding to the number of landmarks correctly identified.
Measured: Through completion of ultrasonographic exam, an average of 30 minutes.
Secondary outcomes (2)
Time used to identify all 6 anatomical landmarks using ultrasound in seconds.
Evaluate the time used to identify all 6 anatomical landmarks using ultrasound.
Measured: Through completion of ultrasonographic exam, an average of 30 minutes.
Depth of each landmark from the skin in centimeters.
Depth of each landmark from the skin in centimeters based on ultrasound measurements.
Measured: Through completion of ultrasonographic exam, an average of 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Apr 2017
- Primary completion19 Oct 2019
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus Interosseous Venous AccessStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SergioB17, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121794
- Sponsor's protocol ID
- 16-1642
- Status last verified
- Aug 2020
- First submitted
- 23 Mar 2017
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Identification of the Proximal Humerus Landmarks for Intra-Osseous Vascular Access Across Different Body Habitus
- ClinicalTrials.gov ID
- NCT03121794
- Acronym / sponsor ID
- 16-1642
- Keywords
- ultrasonography, Intraosseous Vascular access, humerus, anatomic landmark
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 19 Oct 2019 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 20 Apr 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.
Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.
Detailed description
There are three main forms of vascular access: peripheral intravenous (PIV), Central venous (CV) and intraosseous (IO). Of the different types of vascular access PIV and CV access have drawbacks when used during resuscitation, because they can be difficult to obtain when patients are volume depleted as in cases of trauma. Attempting CV access has numerous risks with complications occurring in up to 33% of attempts. These include failed placement (22%), arterial puncture (5%), catheter malposition (4%), pneumothorax (1%) and asystolic cardiac arrest (<1%). Attempting to obtain CV access may also disrupt chest compressions in cases of cardiac arrest. Intraosseous access has been used in scenarios where PIV and CV access is difficult or impossible to obtain. Pharmacokinetic studies and standard practice support the bioequivalence of intraosseous and intravenous administration of common medications. Intravascular depletion does not hinder attempts at IO access, and as the insertion sites are peripheral to the heart, insertion can be done avoiding interruptions in chest compressions. Obtaining proximal humerus interosseous (PHIO) access may also be faster than obtaining both PIV and CV access with a relatively low complication rate. In one survey, complications of IO included difficulty in identifying correct anatomical site (3%), extravasation (3.7%), displacement after insertion (8.5%), and very rarely late complications including compartment syndrome (0.6%), osteomyelitis (0.4%) and skin infection (0.3%).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low BMI | – | Procedure: Ultrasonographic exam, Device: ultrasound machineUltrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2 |
| Moderate BMI | – | Procedure: Ultrasonographic exam, Device: ultrasound machineUltrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam. |
| High BMI | – | Procedure: Ultrasonographic exam, Device: ultrasound machineUltrasonographic identification of proximal humerus landmarks for patients with BMI > 40 kg/m2 will receive ultrasound exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected after chart review of current patients undergoing general, cardiac, thoracic, or vascular surgery. Patients will be approached in the preoperative clinic or during their hospitalization (preoperatively or postoperatively). Informed consent will be obtained prior to performing the study. Participants will be separated into 3 cohorts based on BMI. The number of participants in each cohort is as follows: 10 patients with BMI 18.5 - 25 kg/m2; 10 patients with BMI 30-35 kg/m2, 10 patients with BMI > 40 kg/m2.
Key inclusion criteria (2 listed)
- Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.
- BMI >= 18.5 kg/m^2
Key exclusion criteria (5 listed)
- Limited mobility/ range of motion of arms
- Prior surgical intervention on shoulder or humerus
- History of arm dislocation with internal rotation
- History of arm fracture
- BMI in ranges: 25.1 - 29.9, 35.1 - 39.9
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 |
|---|---|---|
| Ultrasonographic examThe study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks | Procedure or surgery | High BMI, Low BMI, Moderate BMI |
| ultrasound machineRegular ultrasound machine used at Cleveland Clinic | Device | High BMI, Low BMI, Moderate BMI |
Primary outcome
Number of proximal humerus landmarks successfully identified by ultrasound exam
Time frame: Through completion of ultrasonographic exam, an average of 30 minutes.
Two investigators will perform an ultrasonographic exam on each patient, with one investigator examining each side of the body. Each investigator will aim to identify 6 anatomical landmarks: 1. The humeral shaft, 2. The surgical neck of the humerus, 3. The lesser tubercle, 4. The greater tubercle, 5. The intertubercular sulcus 6. The target site in the greater tubercle for needle insertion. Each side will receive a score ranging from 0 to 6 corresponding to the number of landmarks correctly identified.
2 secondary outcomes
Time used to identify all 6 anatomical landmarks using ultrasound in seconds.
Time frame: Through completion of ultrasonographic exam, an average of 30 minutes.
Depth of each landmark from the skin in centimeters.
Time frame: Through completion of ultrasonographic exam, an average of 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 18 Sep 2020.
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 Proximal Humerus Interosseous Venous Access and Anatomic Landmark, run by The Cleveland Clinic 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 5 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 18 Sep 2020. 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?
Number of proximal humerus landmarks successfully identified by ultrasound exam (time frame: Through completion of ultrasonographic exam, an average of 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 18 Sep 2020.