ResuscitationPhase 4CARENCT00631098
Cannulation for Resuscitation
A Phase 4 study testing venous cannulation in people with Resuscitation, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
International CPR guidelines recommend the cannulation of a peripheral vein (antecubital or external jugular) during resuscitation. One reason for preferring the external jugular vein over more peripheral veins is the faster circulation time of drugs during CPR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resuscitation
- What is being tested?
- venous cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2004to Dec 2008
- Phase
- Phase 4
- 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
- Cardiac surgery patients
Who cannot join
- Morbid obesity (BMIover 35)
- Severe cardiac insufficiency (ejection fraction below 30%)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Anesthesiology and Intensive Care/ Kuopio University hospital
Kuopio, 70211
About this study
Official title: The Feasibility of Cannulating External Jugular Vein Compared With Cubital Vein (by Paramedics and Emergency Department Interns)
International CPR guidelines recommend the cannulation of a peripheral vein (antecubital or external jugular) during resuscitation. One reason for preferring the external jugular vein over more peripheral veins is the faster circulation time of drugs during CPR. The differences in circulation time may be over 90 seconds between peripheral and central (internal jugular) veins. However, cannulation of the external jugular vein may be more difficult and time consuming than cannulating cubital veins. There are no studies on the success rate, cannulation time and reliability of venous access comparing central and peripheral cannulation sites.
We hypothesized that cannulation of the external jugular vein (by paramedics and is a demanding procedure in an emergency situation and should not be recommended during resuscitation.
The aims of this study are to compare the feasibility of cannulating the external jugular vein compared to the cubital vein in terms of attempts, cannulation time and reliability of venous access.
Read the detailed description
The protocol includes measurement of:
- The time of cannulation
- Number of attempts of cannulation, Every piercing of skin is counted as one attempt. Maximally three attempts will be allowed.
- Failures. Perforation of vein and subcutaneous hemorrhage, arterial puncture, the appropriate vein is not found, free back flow of blood or free infusion of saline is not achieved the attempt are considered as failures . Cannulation of another site is then started or the study is ended.
The final protocol of the study will be a paired control, randomized prospective study. The randomization will be for the order of cannulation site (internal jugular or cubital vein first) In the final study the cannulation will be performed by emergency department interns and paramedics with advanced cardiac life support skills and licenced by Kuopio University Hospital.
For comparison and describing the experience of the paramedics an enquiry is accomplished and the following data are collected:
- Age
- Experience as a paramedic (years after graduation)
- Theoretical guidance of cannulation (self estimated /hours)
- Practical guidance of cannulation (self estimated/hours)
- Experience of cannulation of the external jugular vein (self estimated/times)
For comparison and describing the experience of the interns in the ER a similar enquiry is accomplished,:
- Age
- Experience as an intern (years after graduation as MD)
- Theoretical guidance of cannulation (self estimated /hours)
- Practical guidance of cannulation (self estimated/hours)
- Cannulation of external jugular vein (self estimated/times) Statistical analysis
The primary endpoint in this study is cannulation time of the two sites (internal jugular and cubital vein). The secondary end points are failure/success of cannulation and reliability of venous access as defined above.
Patient characteristics and anesthetic and operative variables are compared with the t-test for independent samples (continuous variables), or the Mann-Whitney U-test and 2-test (Pearson) or Fishers exact test when appropriate (categorical variables). Cannulation time differences between the groups will be compared with the t-test for independent samples (after tests for homoscedasticity and normality) or Mann-Whitney U-test if appropriate. Success of cannulation will be compared with 2-test (Pearson) or Fishers exact test when appropriate. A p value less than 0.05 is considered statistically significant. Results are given as mean (SD) or number of patients. All statistical analyses will be performed with SPSS version 11.01 software (SPSS Inc, Chicago, IL, USA).
- Conditions
- Resuscitation
- Being tested
- venous cannulation
- Keywords
- Resuscitation, venous cannulation, external jugular vein, cubital vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous cannulationProcedure or surgery
External jugular and cubital vein cannulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cannulation of external jugular vein and cannulation of cubital vein Receives: Procedure: venous cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure in this study is cannulation time of the two sites (internal jugular and cubital vein).
Measured: Cannulation time (minutes)
Secondary outcomes (1)
The secondary end points are failure/success of cannulation and reliability of venous access.
Measured: success of cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Pasi K Lahtinen, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631098
- Sponsor's protocol ID
- KUH5070198
- Acronym
- CARE
- Status last verified
- Jan 2009
- First submitted
- 27 Feb 2008
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Lahtinen P, Musialowicz T, Hyppola H, Kiviniemi V, Kurola J. Is external jugular vein cannulation feasible in emergency care? A randomised study in open heart surgery patients. Resuscitation. 2009 Dec;80(12):1361-4. doi: 10.1016/j.resuscitation.2009.08.026. Epub 2009 Oct 4.
PubMed 19804930
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Cannulating External Jugular Vein Compared With Cubital Vein (by Paramedics and Emergency Department Interns)
- ClinicalTrials.gov ID
- NCT00631098
- Acronym / sponsor ID
- CARE / KUH5070198
- Conditions
- Resuscitation
- Keywords
- Resuscitation, venous cannulation, external jugular vein, cubital vein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Mar 2008 (estimated)
- 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.
International CPR guidelines recommend the cannulation of a peripheral vein (antecubital or external jugular) during resuscitation. One reason for preferring the external jugular vein over more peripheral veins is the faster circulation time of drugs during CPR. The differences in circulation time may be over 90 seconds between peripheral and central (internal jugular) veins. However, cannulation of the external jugular vein may be more difficult and time consuming than cannulating cubital veins. There are no studies on the success rate, cannulation time and reliability of venous access comparing central and peripheral cannulation sites.
We hypothesized that cannulation of the external jugular vein (by paramedics and is a demanding procedure in an emergency situation and should not be recommended during resuscitation.
The aims of this study are to compare the feasibility of cannulating the external jugular vein compared to the cubital vein in terms of attempts, cannulation time and reliability of venous access.
Detailed description
The protocol includes measurement of:
- The time of cannulation
- Number of attempts of cannulation, Every piercing of skin is counted as one attempt. Maximally three attempts will be allowed.
- Failures. Perforation of vein and subcutaneous hemorrhage, arterial puncture, the appropriate vein is not found, free back flow of blood or free infusion of saline is not achieved the attempt are considered as failures . Cannulation of another site is then started or the study is ended.
The final protocol of the study will be a paired control, randomized prospective study. The randomization will be for the order of cannulation site (internal jugular or cubital vein first) In the final study the cannulation will be performed by emergency department interns and paramedics with advanced cardiac life support skills and licenced by Kuopio University Hospital.
For comparison and describing the experience of the paramedics an enquiry is accomplished and the following data are collected:
- Age
- Experience as a paramedic (years after graduation)
- Theoretical guidance of cannulation (self estimated /hours)
- Practical guidance of cannulation (self estimated/hours)
- Experience of cannulation of the external jugular vein (self estimated/times)
For comparison and describing the experience of the interns in the ER a similar enquiry is accomplished,:
- Age
- Experience as an intern (years after graduation as MD)
- Theoretical guidance of cannulation (self estimated /hours)
- Practical guidance of cannulation (self estimated/hours)
- Cannulation of external jugular vein (self estimated/times) Statistical analysis
The primary endpoint in this study is cannulation time of the two sites (internal jugular and cubital vein). The secondary end points are failure/success of cannulation and reliability of venous access as defined above.
Patient characteristics and anesthetic and operative variables are compared with the t-test for independent samples (continuous variables), or the Mann-Whitney U-test and 2-test (Pearson) or Fishers exact test when appropriate (categorical variables). Cannulation time differences between the groups will be compared with the t-test for independent samples (after tests for homoscedasticity and normality) or Mann-Whitney U-test if appropriate. Success of cannulation will be compared with 2-test (Pearson) or Fishers exact test when appropriate. A p value less than 0.05 is considered statistically significant. Results are given as mean (SD) or number of patients. All statistical analyses will be performed with SPSS version 11.01 software (SPSS Inc, Chicago, IL, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: venous cannulationCannulation of external jugular vein and cannulation of cubital vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac surgery patients
Key exclusion criteria (2 listed)
- Morbid obesity (BMIover 35)
- Severe cardiac insufficiency (ejection fraction below 30%)
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 |
|---|---|---|
| venous cannulationExternal jugular and cubital vein cannulation | Procedure or surgery | 1 |
Primary outcome
The primary outcome measure in this study is cannulation time of the two sites (internal jugular and cubital vein).
Time frame: Cannulation time (minutes)
1 secondary outcome
The secondary end points are failure/success of cannulation and reliability of venous access.
Time frame: success of cannulation
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 21 Jan 2009.
- Derived from this study: PubMed 19804930Lahtinen P, Musialowicz T, Hyppola H, Kiviniemi V, Kurola J. Is external jugular vein cannulation feasible in emergency care? A randomised study in open heart surgery patients. Resuscitation. 2009 Dec;80(12):1361-4. doi: 10.1016/j.resuscitation.2009.08.026. Epub 2009 Oct 4.
Related trials for Resuscitation
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
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.
Pasi K Lahtinen, MD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing venous cannulation in people with Resuscitation, run by Kuopio University Hospital at 1 site in Finland.
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 1 inclusion and 2 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 21 Jan 2009. 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 Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome measure in this study is cannulation time of the two sites (internal jugular and cubital vein). (time frame: Cannulation time (minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00631098, which also lists 1 linked publication.
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 21 Jan 2009.