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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01543360
Other study ID # LOCAL/2011/JYL-GB-01
Secondary ID 2011-A01353-38
Status Completed
Phase N/A
First received February 20, 2012
Last updated March 25, 2015
Start date June 2012
Est. completion date May 2013

Study information

Verified date March 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.


Description:

The secondary objectives of this study are to compare the following between the two techniques:

- the success rate of the establishment of a central venous catheter

- the success rate of establishment of a central venous catheter at the first attempt at venipuncture

- for non-failures (eg, a catheter is placed in the first four trys), time to cannulation

- the presence / absence of the following complications:

- arterial puncture (yes / no)

- pneumothorax (yes / no)

- hemothorax (yes / no)

- hematoma (yes / no)

- nerve injury (yes / no)

- aberrant course (yes / no)

The reasons catheter placement failures will also be described.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The patient must have given his/her informed and signed consent

- The patient must be insured or beneficiary of a health insurance plan

- The patient is available for 24 hours of follow-up

- Patient requiring the establishment of a central venous catheter

Exclusion Criteria:

- The patient is in an exclusion period determined by a previous study

- The patient is under judicial protection, under tutorship or curatorship

- The patient refuses to sign the consent

- It is impossible to correctly inform the patient

- The patient is pregnant, parturient, or breastfeeding

- Patient has a body mass index < 15 or > 40

- Congenital or acquired anatomical deformity (radiation therapy, trauma, surgery) of the axillary and/or subclavian regions

- Bleeding disorder (platelets < 50,000, prothrombine < 50%, activated cephaline time > 2 times the control value)

- Severe hypoxemia defined by a ratio PaO2 / FIO2 < 100

- Infection of the puncture area

- Known thrombosis of the subclavian or axillary veins

- Scheduled length of hospitalization less than 24 hours

- Agitated or non-cooperative patient

- The patient has already been included in this study

- subclavian and axillary veins are not simultaneously echogenic on one or both sides (left and right).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Axillary strategy
The first two attempts at central venous catheterization will be performed via the distal approach (axillary vein). The third and fourth attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The same puncture material/devices will be used in both arms of the study.
Subclavian strategy
The first two attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The third and fourth attempts at central venous catheterization will be performed by the distal approach (axillary vein). The same puncture material/devices will be used in both arms of the study.

Locations

Country Name City State
France CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 Gard

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Central venous catheter established within first 2 puncture attempts yes/no approximately 3 minutes Yes
Secondary Central venous catheter established upon first punction attempt yes/no approximately 3 minutes Yes
Secondary Establishment of a central venous catheter yes/no approximately 3 minutes Yes
Secondary The time necessary for the establishment of a central venous catheter For non-failures (ie establishment of a central venous catheter within 4 puncture attempts), the number of minutes necessary for the establishment of a central venous catheter approximately 3 minutes Yes
Secondary The time necessary for the establishment of a central venous catheter all cases, in minutes approximately 3 minutes Yes
Secondary presence/absence of complications arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no) Day 1 Yes
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