Cannulation for Resuscitation (CARE)

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00631098
First received: February 27, 2008
Last updated: January 20, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Resuscitation
Procedure: venous cannulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Feasibility of Cannulating External Jugular Vein Compared With Cubital Vein (by Paramedics and Emergency Department Interns)

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • The primary outcome measure in this study is cannulation time of the two sites (internal jugular and cubital vein). [ Time Frame: Cannulation time (minutes) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary end points are failure/success of cannulation and reliability of venous access. [ Time Frame: success of cannulation ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cannulation of external jugular vein and cannulation of cubital vein
Procedure: venous cannulation
External jugular and cubital vein cannulation

Detailed Description:

The protocol includes measurement of:

  1. The time of cannulation
  2. Number of attempts of cannulation, Every piercing of skin is counted as one attempt. Maximally three attempts will be allowed.
  3. 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:

  1. Age
  2. Experience as a paramedic (years after graduation)
  3. Theoretical guidance of cannulation (self estimated /hours)
  4. Practical guidance of cannulation (self estimated/hours)
  5. 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,:

  1. Age
  2. Experience as an intern (years after graduation as MD)
  3. Theoretical guidance of cannulation (self estimated /hours)
  4. Practical guidance of cannulation (self estimated/hours)
  5. 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac surgery patients

Exclusion Criteria:

  • Morbid obesity (BMIover 35)
  • Severe cardiac insufficiency (ejection fraction below 30%)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631098

Locations
Finland
Department of Anesthesiology and Intensive Care/ Kuopio University hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Principal Investigator: Pasi K Lahtinen, MD Kuopio University Hospital
  More Information

No publications provided by Kuopio University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pasi Lahtinen, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00631098     History of Changes
Other Study ID Numbers: KUH5070198
Study First Received: February 27, 2008
Last Updated: January 20, 2009
Health Authority: Finland: Research Ethics Committee, Hospital District of Northern Savo

Keywords provided by Kuopio University Hospital:
Resuscitation
venous cannulation
external jugular vein
cubital vein

ClinicalTrials.gov processed this record on September 29, 2014