Ultrasound Cannulation of the Internal Jugular Vein
| ISRCTN | ISRCTN61258470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61258470 |
| Secondary identifying numbers | Ultrasound/022006 |
- Submission date
- 10/04/2006
- Registration date
- 23/05/2006
- Last edited
- 21/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dimitrios Karakitsos
Scientific
Scientific
Intensive Care Unit
General State Hospital of Athens
154 Mesogeion Avenue
Athens
11527
Greece
| Phone | +30 (0)694 7127965 |
|---|---|
| karakd@edu.med.uoc.gr |
Study information
| Study design | Prospective, randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Ultrasound Cannulation of the Internal Jugular Vein: a prospective randomised controlled study |
| Study objectives | This study was designed to evaluate whether real-time ultrasound-guided cannulation of the internal jugular vein is superior to the standard landmark method. As of 08/11/2010 this record was updated to include an addition to the inclusion criteria as a result of a protocol change in January 2006. This is as follows: "Ultrasound guided cannulation of the internal jugular vein versus the landmark method was extended at the subclavian vein site as from 2006 until 2010 in the same critical care population following the same methodology and the same protocol. Currently, 200 additional patients were enlisted for the ultrasound group and 201 additional patients were enlisted for the landmark group concerning the cannulation of the subclavian vein." Thus, the inclusion criteria have been updated, and the target number of participants has been increased from 900 to 1301. |
| Ethics approval(s) | The study was in conformation with the principles outlined in the Declaration of Helsinki and was approved by the Institutional Ethics Committee in 1999 (ref: 1999/02/ICUGG) |
| Health condition(s) or problem(s) studied | Critically ill patients |
| Intervention | Ultrasound-guided cannulation of the internal jugular vein versus the standard landmark method |
| Intervention type | Other |
| Primary outcome measure | Cannulation of the internal jugular vein was achieved in all patients using ultrasound and in 425 of the patients (94.4%), the landmark technique (p <0.001) was used. Average access time (skin to vein) and the number of attempts were significantly reduced in the ultrasound group of patients compared to the landmark group (p<0.001). In the landmark group, puncture of the carotid artery occurred in 10.6% of patients, hematoma in 8.4%, hemothorax in 1.7%, pneumothorax in 2.4% and central venous catheter-associated blood stream infections in 16% which were all significantly increased compared to the ultrasound group (p<0.001). |
| Secondary outcome measures | There were no significant differences in gender, age, body mass index, left or right side of cannulation and in the presence of risk factors for difficult venous cannulation such as prior catheterization, limited sites for access attempts, previous difficulties during catheterization, previous mechanical complication, known vascular abnormality, untreated coagulopathy, skeletal deformity and cannulation during cardiac arrest between the two groups of patients. Furthermore, the physicians who performed the procedures had comparable experience in the placement of central venous catheters (p = non-significant). |
| Overall study start date | 01/01/2000 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1301 (added as of 08/11/2010; previously was 900) |
| Key inclusion criteria | Amended as of 08/11/2010: Critical care patients which are hospitalised in the intensive care unit from January 2000 to December 2006 and were all mechanically ventilated requiring central/subclavian venous access for various therapeutic reasons. Initial information at time of registration: Critical care patients which are hospitalised in the intensive care unit from January 2000 to December 2006 and were all mechanically ventilated requiring central venous access for various therapeutic reasons. |
| Key exclusion criteria | Patients who were not on mechanical ventilation |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Greece
Study participating centre
Intensive Care Unit
Athens
11527
Greece
11527
Greece
Sponsor information
General State Hospital of Athens (Greece)
Hospital/treatment centre
Hospital/treatment centre
Intensive Care Unit
154 Mesogeion Avenue
Athens
11527
Greece
| Phone | +30 (0)210 7480188 |
|---|---|
| icugg@otenet.gr | |
"ROR" |
https://ror.org/00zq17821 |
Funders
Funder type
Hospital/treatment centre
General State Hospital of Athens (Greece) - Intensive Care Unit
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2006 | Yes | No | |
| Results article | results | 01/07/2011 | Yes | No |
