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Comparison of Different Techniques on First Attempt Success in Difficult Vascular Access Patients

Comparison Of Standart Technique, Ultrasonography And Near-Infrared Light In Difficult Peripheral Vascular Access: A Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04821362
Enrollment
270
Registered
2021-03-29
Start date
2019-04-15
Completion date
2020-03-01
Last updated
2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Access

Keywords

peripheral intravenous catheter, near infrared, ultrasound

Brief summary

The aim of this study is to investigate whether there is any difference between the use of standard techniques, ultrasonography and infra-red light for the success of the first attempt in difficult peripheral vascular access patients. Patients who have difficult vascular access history ( often need 2 or more attempt to access peripheral intravenous catheter), who do not have palpable or visible vein after tourniquet, and who have the hard anticipation according to operator ( easy-moderate-hard) are included to study. The primary objective is planned as the determination of the success rate in the first attempt. Secondary aims of the study were determined as: total procedure time,total number of attempts, and need for rescue procedure

Detailed description

Before starting the study, all nurses who work as senior nurse in the emergency department will be informed. All the Emergency Nurses who are willing to participate in the study (the consent form from the nurses who will be included in the study) will be taken pretest to measure their knowledge about ultrasound and infrared light usage for intravenous access. Then, the 4-hours theoretical and 4-hours practical lesson accompanied by an infrared device and a single-operator with horizontal and longitudinal vascular access with ultrasonography will be explained by the experienced Emergency Medicine Specialist to all the senior nurses . Introduction of ultrasonography device in the theoretical training, principles of using, linear probe and its properties, horizontal and longitudinal axis concepts used in the determination of venous structures, principles of determination of venous structures in ultrasonography, differentiation of artery and nerve structures will be explained. The introduction of the device for infrared light, the principles of operation, the distance between the light and operation area and the positioning of the device will be discussed. Practical trainings will be arranged on horizontal and longitudinal axes by using ultrasound on lifeless forearm mannequin. In the practical lesson in the infrared light device, the device will be kept in a proper distance on the live mannequin, being positioned perpendicular to the area to be treated and identification of the vascular structures while the device is operating. After the theoretical and practical training, all of the senior nurses will be evaluated with posttest and the nurses with a success rate of 80% will be included in the study. Adult patients and/ or their relatives will be included to study if they meet any of the inclusion criteria and accept the consent form. The randomization of the patients according to the number of nurses participating in the study will be determined by the responsible researchers before the study begins. For example, in the study where 10 senior nurses will participate, the number of targeted patients will be at least 270 and 10 boxes specific to each nurse will be created. These boxes will be kept in the senior nurse room. Each box will have 27 different application methods (9 usg, 9 infrared, 9 standard methods). The nurse who accepts to participate in the research will apply the method according to the procedure which will be randomly drawn from this box. In this way, an equal number of procedures will be provided for each nurse and an equal number of procedures will be provided for each nurse. The application of the procedure on the longitudinal or horizontal axis will be left to senior nurse discretion. In the infrared light approach, 2 applicators will be operated. While holding the auxiliary infra-red light, the practitioner will perform the operation at a distance of 20 cm perpendicular to the process zone. The place of application will be left to the discretion of the practitioner. In order to establish a standard approach between the procedures performed, 18 gauge catheter will be used at the arm and the forearm areas, 20 gauge for the other regions. After the tourniquet is inserted, the procedure time will be calculated as seconds. In order for the successful vascular access to be considered successful, at least 5 ml of blood should be taken or at least 5 ml of saline fluid should be given. In all three approaches, if there is no success after 2 attempts, the 3rd and subsequent trials will be evaluated as rescue interventions and these interventions will be left to the discretion of the practitioner and this will be recorded observably (standard approach, usg, infra red light, central vascular, intraosseous approach, calling senior nurse, calling emergency medicine physician etc.). For all three approaches, the success of the first trial, the total duration of the procedure (in seconds), the total number of trials, and rescue method need will be recorded.

Interventions

In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.

DEVICENear Infrared Device Group

In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

A prospective, experimental, randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who have previously described a history of difficult vascular access. * Patients who do not have palpable or visible veins after tourniquet placement or who have been referred to unusual locations due to the lack of appropriate veins in the upper extremity. * Patients who are expected to be hard to perform the procedure by the senior nurse.

Exclusion criteria

* The patients who do not need vascular access. * Patients who do not give consent * Pregnant patients * Patients who are under 18 years old * Patients who require immediate intervention due to any life-threatening condition.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Success in the First AttemptFrom the time of randomization until the time of the first successful attempt, up to 30 minutes.The success numbers of the first attempt during the implementation of all three methods

Secondary

MeasureTime frameDescription
Procedure Time.From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.Time of the intravenous catheter placement procedure
Patients Who Need Rescue MethodsUp to 1 hour.The method used as a rescue method when the primary method fails to achieve success.
Number of AttemptsFrom the time of randomization until the time of the successful attempt, up to 1 hour.Number of attempts to successfully insert peripheral vascular cateter.

Countries

Turkey (Türkiye)

Participant flow

Pre-assignment details

Patients who need urgent care, \<18 years, pregnant, and declined to participate were not included in to study groups.

Participants by arm

ArmCount
Standard Technique Group
In this group, peripheral intravenous catheter insertion will be performed routinely.
90
Ultrasound Group
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures. Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
90
Near Infrared Device Group
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400. Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
90
Total270

Baseline characteristics

CharacteristicUltrasound GroupNear Infrared Device GroupTotalStandard Technique Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
41 Participants43 Participants133 Participants49 Participants
Age, Categorical
Between 18 and 65 years
49 Participants47 Participants137 Participants41 Participants
Age, Continuous64 years64 years65 years68.5 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
90 Participants90 Participants270 Participants90 Participants
Region of Enrollment
Turkey
90 Participants90 Participants270 Participants90 Participants
Sex: Female, Male
Female
51 Participants60 Participants167 Participants56 Participants
Sex: Female, Male
Male
39 Participants30 Participants103 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 900 / 900 / 90
other
Total, other adverse events
0 / 900 / 900 / 90
serious
Total, serious adverse events
0 / 900 / 900 / 90

Outcome results

Primary

Number of Participants With Success in the First Attempt

The success numbers of the first attempt during the implementation of all three methods

Time frame: From the time of randomization until the time of the first successful attempt, up to 30 minutes.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Technique GroupNumber of Participants With Success in the First Attempt56 Participants
Ultrasound GroupNumber of Participants With Success in the First Attempt71 Participants
Near Infrared Device GroupNumber of Participants With Success in the First Attempt53 Participants
Secondary

Number of Attempts

Number of attempts to successfully insert peripheral vascular cateter.

Time frame: From the time of randomization until the time of the successful attempt, up to 1 hour.

ArmMeasureValue (MEDIAN)
Standard Technique GroupNumber of Attempts1 attempts
Ultrasound GroupNumber of Attempts1 attempts
Near Infrared Device GroupNumber of Attempts1 attempts
Secondary

Patients Who Need Rescue Methods

The method used as a rescue method when the primary method fails to achieve success.

Time frame: Up to 1 hour.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Technique GroupPatients Who Need Rescue Methods17 Participants
Ultrasound GroupPatients Who Need Rescue Methods17 Participants
Near Infrared Device GroupPatients Who Need Rescue Methods25 Participants
Secondary

Procedure Time.

Time of the intravenous catheter placement procedure

Time frame: From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.

ArmMeasureValue (MEDIAN)
Standard Technique GroupProcedure Time.72 Seconds
Ultrasound GroupProcedure Time.107 Seconds
Near Infrared Device GroupProcedure Time.82 Seconds

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026