Studies
| Study First Submitted Date | 2022-05-19 |
| Study First Posted Date | 2022-05-24 |
| Last Update Posted Date | 2023-08-01 |
| Start Month Year | August 1, 2019 |
| Primary Completion Month Year | April 1, 2021 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-08-01 |
Detailed Descriptions
| Sequence: | 20599370 |
| Description | Central venous cannulation (CVC) is the cannulation of a large central vein in neck (internal jugular vein), chest (subclavian or axillary) or groin (femoral vein). It is a standard clinical method performed for the monitoring of central venous pressure, temporary haemodialysis, drug administration (drugs irritating peripheral veins, chemotherapy, concentrated vasoactive drugs ) rapid infusion of fluids, inadequate peripheral intravenous access and sampling site for repeated blood sampling. There are different techniques for Central venous cannulation which include anatomical landmark and ultrasound guided (USG) technique. Previous studies have shown that the successful IJV cannulation using anatomical landmark technique was 85% as compared to ultrasound guided IJV cannulation which was 95%.The median catheterisation time of internal jugular vein via ultrasound guided (USG) is shorter than anatomical landmark technique. There has been little evidence regarding the use of ultrasound guidance for internal jugular vein cannulation at a tertiary care hospital in our population. Furthermore with widespread availability of ultrasound, Internal Jugular vein can be successfully cannulated with decreasing number of attempts, less time consumption and decrease in the incidence of complications. |
Facilities
| Sequence: | 198804429 |
| Name | Aga Khan University hospital |
| City | Karachi |
| State | Sindh |
| Zip | 74800 |
| Country | Pakistan |
Conditions
| Sequence: | 51857897 |
| Name | Catheterization, Central Venous |
| Downcase Name | catheterization, central venous |
Id Information
| Sequence: | 39907627 |
| Id Source | org_study_id |
| Id Value | 3488-Ane-ERC-15 |
Countries
| Sequence: | 42305856 |
| Name | Pakistan |
| Removed | False |
Design Groups
| Sequence: | 55285441 | Sequence: | 55285442 | Sequence: | 55285443 |
| Group Type | Active Comparator | Group Type | Active Comparator | Group Type | Active Comparator |
| Title | ALT | Title | USG-Pre | Title | USG -RT |
Interventions
| Sequence: | 52178120 | Sequence: | 52178121 | Sequence: | 52178122 |
| Intervention Type | Procedure | Intervention Type | Procedure | Intervention Type | Procedure |
| Name | Anatomical Landmark technique | Name | Ultrasound-guided pre location technique | Name | Ultrasound-guided real-time technique |
| Description | anatomical landmarks (sternocleidomastoid muscles, sternal notch, cricoid cartilage, carotid artery and clavicle) will be palpated. A 3cc syringe with 21 gauge needle (locator) will be used first to locate IJV at the apex of the triangle formed by the two heads of the sternocleidomastoid muscle. After successful location, an introducer needle of 18 gauge, attached with a 5 ml syringe, will be inserted at the same point. The introducer needle will be directed towards the ipsilateral nipple at an angle of 20-30° with the skin | Description | In Group Ultrasound-guided pre location technique, venipuncture site will be determined using ultrasound probe which will be then removed and locator needle of 21 gauge will be used first to confirm IJV location. The cannulation or venipuncture will be performed at the marked point of locator needle by the use of 18 gauge introducer needle. | Description | In Group Ultrasound-guided real-time technique, cannulation or venipuncture will be performed under real-time imaging using 18 gauge needle i-e ultrasound will be used for prelocation and puncturing of IJV and locator needle will not be used |
Keywords
| Sequence: | 79358192 | Sequence: | 79358193 | Sequence: | 79358194 | Sequence: | 79358195 |
| Name | Cardiac Surgery | Name | Central Venous Catheter | Name | Anatomical Landmark | Name | Ultrasound |
| Downcase Name | cardiac surgery | Downcase Name | central venous catheter | Downcase Name | anatomical landmark | Downcase Name | ultrasound |
Design Outcomes
| Sequence: | 176362392 | Sequence: | 176362393 | Sequence: | 176362394 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Success Rate | Measure | Time duration for each technique | Measure | Incidence of Complications |
| Time Frame | Day 1 | Time Frame | Day 1 | Time Frame | Day 1 |
| Description | Success rate will be measured according to the number of attempts. The cannulation of right Internal Jugular Vein within the first three attempts. | Description | Measurment of time in minutes | Description | Look for carotid puncture, haematoma formation , pneumothorax |
Sponsors
| Sequence: | 48029314 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Aga Khan University Hospital, Pakistan |
Design Group Interventions
| Sequence: | 67773604 | Sequence: | 67773605 | Sequence: | 67773606 |
| Design Group Id | 55285441 | Design Group Id | 55285442 | Design Group Id | 55285443 |
| Intervention Id | 52178120 | Intervention Id | 52178121 | Intervention Id | 52178122 |
Eligibilities
| Sequence: | 30582225 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 65 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Age 18-65 years ASA (American society of Anesthesiologists) status 1 to 3 requiring central venous catheter during surgical procedure ASA (American society of Anesthesiologists) status 4 patients coming for cardiac surgery Exclusion Criteria: Patients with a history of following Previous head and neck surgery Head and neck mass or cancer. Superior vena cava syndrome. Coagulopathy. Infection at the cannulation site. Previous central venous access. Anatomical Changes due to surgery or any pathology in the neck which can lead to distortion of anatomical land marks in the region of puncture. Raised intracranial pressure (ICP). Patients coming for emergency surgery Patients with BMI (Body Mass Index) more than 30 Patient refusal |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253856575 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Actual Duration | 20 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Maximum Age Num | 65 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 2 |
Designs
| Sequence: | 30330390 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | Single |
| Subject Masked | True |
Responsible Parties
| Sequence: | 28709180 |
| Responsible Party Type | Principal Investigator |
| Name | Syed Shabbir Ahmed |
| Title | Senior Instructor |
| Affiliation | Aga Khan University Hospital, Pakistan |
Study References
| Sequence: | 51750541 | Sequence: | 51750542 | Sequence: | 51750543 |
| Pmid | 24106363 | Pmid | 17052555 | Pmid | 21991734 |
| Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | Ray BR, Mohan VK, Kashyap L, Shende D, Darlong VM, Pandey RK. Internal jugular vein cannulation: A comparison of three techniques. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):367-71. doi: 10.4103/0970-9185.117115. | Citation | Leung J, Duffy M, Finckh A. Real-time ultrasonographically-guided internal jugular vein catheterization in the emergency department increases success rates and reduces complications: a randomized, prospective study. Ann Emerg Med. 2006 Nov;48(5):540-7. doi: 10.1016/j.annemergmed.2006.01.011. Epub 2006 Feb 21. | Citation | Kaye AD, Fox CJ, Hymel BJ, Gayle JA, Hawney HA, Bawcom BA, Cotter TD. The importance of training for ultrasound guidance in central vein catheterization. Middle East J Anaesthesiol. 2011 Feb;21(1):61-6. |