Peripheral Venous CatheterizationSPECTRANCT04853264
Ultrasound Guided Peripheral Catheterization Increases First-attempt Success Rate
A study testing Ultrasound-guided peripheral venipuncture and Conventional peripheral venipuncture in people with Peripheral Venous Catheterization and Ultrasonography, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Randomized clinical trial to test the assertiveness on the peripheral vein puncture attempt by comparing two methods: peripheral venipuncture catheterization using the conventional technique (vein visualization and palpation) versus ultrasound-guided venous puncture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Venous Catheterization, Ultrasonography
- What is being tested?
- Ultrasound-guided peripheral venipuncture and Conventional peripheral venipuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Sep 2021to 31 Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Adults, age = or > 18 years;
- Both sex;
- Admitted to the clinical inpatient units of the hospital where the study will be conducted (HCPA), with indication of peripheral venous puncture;
- Patients who do not configure emergency care.
Who cannot join
- Patients who have already received ultrasound-guided peripheral venipuncture at the current hospitalization;
- Patients in a critical or unstable clinical condition;
- Patients admitted to surgical units at HCPA;
- Patients in coronavirus (COVID-19) care units.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul - Post Graduated Program
Porto Alegre, Rio Grande do Sul, 90035003
About this study
Official title: ultraSound Guided PEripheral Catheterization Increases First-atTempt Success RAte in Hospitalized Patients When Compared With Conventional Technique: SPECTRA - Randomized Clinical Trial
Randomized clinical trial to test the assertiveness on the peripheral vein puncture attempt by comparing two methods: peripheral venipuncture catheterization using the conventional technique (vein visualization and palpation) versus ultrasound-guided venous puncture.
Patients with indication of peripheral venous puncture, admitted to the clinical inpatient units on the hospital where the study will be conducted (Hospital de Clinicas de Porto Alegre - HCPA) will be enrolled in this single-center trial and will be randomized to conventional peripheral venipuncture performed by a registered nurse; or ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.
Read the detailed description
Study Protocol:
When there is a need for peripheral venous access for the inpatient, the medical or nursing care team will contact the researchers, informing the personal data of the possible candidate to participate in the study. By fulfilling the eligibility criteria, the patient will be invited and informed about the study proposal; and, if he agrees to participate, he will sign the consent form. The type of procedure to be performed will be randomized through a draw. The procedure options are:
Intervention: peripheral venipuncture guided by ultrasound by a registered nurse with expertise in vascular access, or Control: conventional peripheral venipuncture by an inpatient care registered nurse.
Individuals who do not agree to participate in the study will have their data stored on a patient exclusion checklist.
In both groups, intervention and control, up to two attempts will be made by the same professional and, if there is no success on the procedure, another professional will be designated for two more attempts. Ultrasound Site Rite 8 or Ultrasound Site Rite 5, which are portable ultrasound devices that include 2D ultrasound imaging in real time, will be used on the Intervention Group (1) procedure.
The peripheral venipuncture procedure for both groups will be performed according to the standard operating procedures recommended by the institution where the study will be conducted (HCPA). The catheters to be used will be the peripheral venous catheters made available by the institution.
If there is a failure of puncture in the Control Group (2), the study participant will follow the institution's routine to adapt an appropriate vascular access, which is the activation of a nurse specialist in vascular access, who can perform peripheral venipuncture guided by ultrasound. In the event of a new insertion failure, the care team (doctor and nurse) discusses the case to define a new approach according to the infusional therapy, considering the protocol for the indication of venous vascular accesses at the institution. Thereafter, the patient can proceed for oral treatment, insertion of a peripherally inserted central catheter, insertion of a short-term central venous catheter, hypodermoclysis, long-term central venous catheter (totally or semi-implanted), according to the decision of the assistant team.
In the case of failure of the puncture in the Intervention Group (1), the study participant will follow the same routine of the institution, as explained above, for the adequacy of an adequate vascular access. However, in this case, the nurse specialist in vascular access will not be contacted, as the intervention procedure already uses ultrasound.
All participants who successfully insert a peripheral venous catheter in both groups will be monitored for the occurrence of any event related to the procedure from the time of insertion of the catheter until the loss of access for any reason, removal of the device at the end of therapy, discharge, death or eight days of follow-up, whichever comes first. Peripheral venous access that remains for more than eight days will be counted as event-free, access survival. Study participants with failed insertion will have the outcome computed in the database and will be followed up for another 48 hours to assess any complications resulting from the puncture attempt.
- Conditions
- Peripheral Venous Catheterization, Ultrasonography
- Being tested
- Ultrasound-guided peripheral venipuncture, Conventional peripheral venipuncture
- Keywords
- Peripheral venous catheterization, Ultrasonography, Nursing, Clinical trial, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided peripheral venipunctureDevice
Ultrasound-guided peripheral venipuncture performed by a proficient vascular access registered nurse. The procedure will be performed according to the standard operational protocol for ultrasound guided peripheral venipuncture instituted at the hospital where the study will be conducted. Site Rite 8 or Site Rite 5 ultrasound machines (Bard Access Systems, Inc., USA) will be used on the procedures.
Conventional peripheral venipunctureDevice
Conventional peripheral venipuncture performed by a registered nurse at the clinical inpatient unit. The procedure will be performed according to the standard operational protocol for peripheral venipuncture instituted in the hospital where the study will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: intervention group | Experimental | Ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access. Receives: Device: Ultrasound-guided peripheral venipuncture |
| Control group | Active comparator | Conventional peripheral venipuncture performed by a registered nurse. Receives: Device: Conventional peripheral venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of venipuncture attempts
Success in the first attempt of venipuncture will be defined by the presence of blood reflux and infusion of 2 mL of saline without complaint of pain or signs of infiltration around the vessel.
The number of times the vascular device reaches the skin and subcutaneous tissue with or without rupture of the vessel will be computed.
Measured: Immediately after the procedure.
Secondary outcomes (7)
Time to obtain peripheral venous access
The time to obtain peripheral venous access will be measured in minutes. The computation of the total time of the procedure will start from the entry of the nurse into the patient's room and it will end when this professional leaves the room. In case of failure in venipuncture, the total time of the procedure will be considered as the sum of the time used in the procedure (without assertion) and the period necessary to obtain a functional venous access.
Measured: During the procedure
Classification of peripheral venous system conditions
Predictors of difficult peripheral intravenous access will be recorded, considering demographic data (gender, age, weight, skin color, etc.) social behavior (active smoking, intravenous drug abuse and alcohol abuse), history of illnesses (heart and pulmonary diseases, vascular diseases, history of chemotherapy treatment, hematological status, use of drugs that interfere with cutaneous and vascular integrity, hypovolemia, hemodialysis, prolonged infusion therapies, skin changes, presence of scars and tattoos, dehydration, etc.) and history of difficult venous access.
Measured: Right before the procedure
Peripheral venous catheters characteristics
Describe the technical specificities of the intravenous catheters used in the procedures, in terms of caliber and length.
Measured: Before the procedure.
Vascular and device complications
Complications that might occur during the permanence of the vascular access device (phlebitis, obstruction, leakage, infiltration, etc), measured through clinical assessment. In the case of the development of phlebitis, it will be evaluated through the application of the Visual Infusion Phlebitis Scale (from the Infusion Nurses Society), which classifies the lesion up to five degrees, according to the progression and severity of the signs and symptoms.
Measured: Up to 8 days.
Venipuncture durability without complications
The time of permanence of the venous access without complications will be measured in days, counting from the day of insertion until the removal of the catheter for any reason (complications, end of therapy, discharge, death or eight days of follow-up). Venous accesses will follow the insertion site exchange guideline, that is, it will be exchange only when clinically indicated, in case of identified complication.
Measured: Up to 8 days.
Infusional therapy characteristics and venipuncture durability
The characteristics of the prescribed intravenous therapy and the durability of peripheral venous access will be assessed daily using specific forms, developed by the authors. The following data will be collected regarding the prescribed intravenous therapy: medication in use, dose, frequency, and estimated duration of therapy.
Measured: Up to 8 days.
Costs related to the venipuncture techniques used
Through specific forms, developed by the authors, the following will be computed: the number of catheters used, the complementary materials used and their quantities, the type of dressing for fixing the catheter and the time spent to obtain peripheral venous access.
Measured: Up to 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start23 Sep 2021
- Primary completion30 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a randomized, parallel, controlled, blinded for data collection and analysis, single-center clinical trial; this study will follow the guidelines of the Consolidated Standards of Reporting Trials (CONSORT).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eneida R Rabelo-Silva, RN, MSc, ScD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853264
- Sponsor's protocol ID
- 39802620.0.0000.5327
- Acronym
- SPECTRA
- Status last verified
- Nov 2022
- First submitted
- 16 Apr 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Database
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ultraSound Guided PEripheral Catheterization Increases First-atTempt Success RAte in Hospitalized Patients When Compared With Conventional Technique: SPECTRA - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04853264
- Acronym / sponsor ID
- SPECTRA / 39802620.0.0000.5327
- Conditions
- Peripheral Venous Catheterization, Ultrasonography
- Keywords
- Peripheral venous catheterization, Ultrasonography, Nursing, Clinical trial, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 21 Apr 2021 (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.
Randomized clinical trial to test the assertiveness on the peripheral vein puncture attempt by comparing two methods: peripheral venipuncture catheterization using the conventional technique (vein visualization and palpation) versus ultrasound-guided venous puncture.
Patients with indication of peripheral venous puncture, admitted to the clinical inpatient units on the hospital where the study will be conducted (Hospital de Clinicas de Porto Alegre - HCPA) will be enrolled in this single-center trial and will be randomized to conventional peripheral venipuncture performed by a registered nurse; or ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.
Detailed description
Study Protocol:
When there is a need for peripheral venous access for the inpatient, the medical or nursing care team will contact the researchers, informing the personal data of the possible candidate to participate in the study. By fulfilling the eligibility criteria, the patient will be invited and informed about the study proposal; and, if he agrees to participate, he will sign the consent form. The type of procedure to be performed will be randomized through a draw. The procedure options are:
Intervention: peripheral venipuncture guided by ultrasound by a registered nurse with expertise in vascular access, or Control: conventional peripheral venipuncture by an inpatient care registered nurse.
Individuals who do not agree to participate in the study will have their data stored on a patient exclusion checklist.
In both groups, intervention and control, up to two attempts will be made by the same professional and, if there is no success on the procedure, another professional will be designated for two more attempts. Ultrasound Site Rite 8 or Ultrasound Site Rite 5, which are portable ultrasound devices that include 2D ultrasound imaging in real time, will be used on the Intervention Group (1) procedure.
The peripheral venipuncture procedure for both groups will be performed according to the standard operating procedures recommended by the institution where the study will be conducted (HCPA). The catheters to be used will be the peripheral venous catheters made available by the institution.
If there is a failure of puncture in the Control Group (2), the study participant will follow the institution's routine to adapt an appropriate vascular access, which is the activation of a nurse specialist in vascular access, who can perform peripheral venipuncture guided by ultrasound. In the event of a new insertion failure, the care team (doctor and nurse) discusses the case to define a new approach according to the infusional therapy, considering the protocol for the indication of venous vascular accesses at the institution. Thereafter, the patient can proceed for oral treatment, insertion of a peripherally inserted central catheter, insertion of a short-term central venous catheter, hypodermoclysis, long-term central venous catheter (totally or semi-implanted), according to the decision of the assistant team.
In the case of failure of the puncture in the Intervention Group (1), the study participant will follow the same routine of the institution, as explained above, for the adequacy of an adequate vascular access. However, in this case, the nurse specialist in vascular access will not be contacted, as the intervention procedure already uses ultrasound.
All participants who successfully insert a peripheral venous catheter in both groups will be monitored for the occurrence of any event related to the procedure from the time of insertion of the catheter until the loss of access for any reason, removal of the device at the end of therapy, discharge, death or eight days of follow-up, whichever comes first. Peripheral venous access that remains for more than eight days will be counted as event-free, access survival. Study participants with failed insertion will have the outcome computed in the database and will be followed up for another 48 hours to assess any complications resulting from the puncture attempt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It's a randomized, parallel, controlled, blinded for data collection and analysis, single-center clinical trial; this study will follow the guidelines of the Consolidated Standards of Reporting Trials (CONSORT).
| Arm | Type | Receives |
|---|---|---|
| Experimental: intervention group | Experimental | Device: Ultrasound-guided peripheral venipunctureUltrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access. |
| Control group | Active comparator | Device: Conventional peripheral venipunctureConventional peripheral venipuncture performed by a registered nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, age = or > 18 years;
- Both sex;
- Admitted to the clinical inpatient units of the hospital where the study will be conducted (HCPA), with indication of peripheral venous puncture;
- Patients who do not configure emergency care.
Key exclusion criteria (4 listed)
- Patients who have already received ultrasound-guided peripheral venipuncture at the current hospitalization;
- Patients in a critical or unstable clinical condition;
- Patients admitted to surgical units at HCPA;
- Patients in coronavirus (COVID-19) care units.
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 |
|---|---|---|
| Ultrasound-guided peripheral venipunctureUltrasound-guided peripheral venipuncture performed by a proficient vascular access registered nurse. The procedure will be performed according to the standard operational protocol for ultrasound guided peripheral venipuncture instituted at the hospital where the study will be conducted. Site Rite 8 or Site Rite 5 ultrasound machines (Bard Access Systems, Inc., USA) will be used on the procedures. | Device | Experimental: intervention group |
| Conventional peripheral venipunctureConventional peripheral venipuncture performed by a registered nurse at the clinical inpatient unit. The procedure will be performed according to the standard operational protocol for peripheral venipuncture instituted in the hospital where the study will be conducted. | Device | Control group |
Primary outcome
Number of venipuncture attempts
Time frame: Immediately after the procedure.
Success in the first attempt of venipuncture will be defined by the presence of blood reflux and infusion of 2 mL of saline without complaint of pain or signs of infiltration around the vessel. The number of times the vascular device reaches the skin and subcutaneous tissue with or without rupture of the vessel will be computed.
7 secondary outcomes
Time to obtain peripheral venous access
Time frame: During the procedure
Classification of peripheral venous system conditions
Time frame: Right before the procedure
Peripheral venous catheters characteristics
Time frame: Before the procedure.
Vascular and device complications
Time frame: Up to 8 days.
Venipuncture durability without complications
Time frame: Up to 8 days.
Infusional therapy characteristics and venipuncture durability
Time frame: Up to 8 days.
Costs related to the venipuncture techniques used
Time frame: Up to 8 days.
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 3 Nov 2022.
- Individual participant dataSharing planned: Yes. Database
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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.
Eneida R Rabelo-Silva, RN, MSc, ScD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided peripheral venipuncture and Conventional peripheral venipuncture in people with Peripheral Venous Catheterization and Ultrasonography, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 4 inclusion and 4 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 3 Nov 2022. 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 Brazil. 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 venipuncture attempts (time frame: Immediately after the procedure.). 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 3 Nov 2022.