Clinical trial NCT02472132: The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter
Official title: The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter and for the Detection of Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Venous Catheter
Keywords: Central Venous Catheter
Point Of Care Ultra Sound
Sub Clavian Vein
Internal Jugular Vein
Trans Thoracic Echocardiography
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Central venous catheter (CVC) is an essential tool in the management of both medical and surgical patients. Establishing venous access is critically important and is sometimes technically challenging. Among the many indications for point of care ultrasound (POCUS), ultrasound-guided venous catheter placement is well described and increasingly used. This study was designed to evaluate the utility of peri procedural transthoracic echocardiography (TTE) as a tool for positioning CVC and for ruling out complications.

Detailed description: Central venous catheter (CVC) is an essential tool in the management of both medical and surgical patients. Establishing venous access is critically important and is sometimes technically challenging. Among the many indications for point of care ultrasound (POCUS), ultrasound-guided venous catheter placement is well described and increasingly used. This study was designed to evaluate the utility of peri procedural transthoracic echocardiography (TTE) as a tool for positioning CVC and for ruling out complications.

The study population will be screened at the internal wards and medical intensive care unit of Soroka Medical Center.

Research candidates' files will be screened routinely by a study coordinator. The study population will be enrolled according to the inclusion and exclusion criteria.

The primary objective for the study is to evaluate whether the use of POCUS in CVC insertion can help inaccurate CVC tip placement, detect misplacement and complications and better than chest X ray.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted to internal ward or medical intensive care unit
2. Patients in need for central venous catheter in the subclavian or internal jugular veins

Exclusion Criteria:

1. Subject currently enrolled in another investigational study
2. Surgical patients with open abdomen covered with bogota bag or vac - pac
3. Patients with pneumothorax prior to central venous catheter insertion
4. Patients in need for central venous catheter for hemodialysis

Primary outcomes:
measure: Rate of misplacement of the tip of CVC.
timeFrame: 6 months
Secondary outcomes:
measure: Rate of ventricular arrhythmia during line insertion while using POC US
timeFrame: 6 months
measure: Duration time of CVC insertion using POC US
timeFrame: 6 months
measure: Number of CVC insertion complications using POC US
timeFrame: 6 months
measure: Sensitivity (score-the device's ability to identify a condition correctly) of POC US in detection of CVC insertion complications
timeFrame: 6 months
measure: Specificity (score-the device's ability to exclude a condition correctly) of POC US in detection of CVC insertion complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
References:
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