Overview

This trial is active, not recruiting.

Condition central venous catheter
Treatment poc us
Sponsor Soroka University Medical Center
Start date July 2015
End date October 2016
Trial size 186 participants
Trial identifier NCT02472132, SOR-0131-15-CTIL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Prospective implantation of POC US for CVC tip placement.
poc us
Use of point of care ultrasound in insertion of CVC
(No Intervention)
Retrospective data collection for CVC placement in the medical and surgical ICUs, before the initiation of the study and without the use of POCUS for CVC tip placement.

Primary Outcomes

Measure
Rate of misplacement of the tip of CVC.
time frame: 6 months

Secondary Outcomes

Measure
Rate of ventricular arrhythmia during line insertion while using POC US
time frame: 6 months
Duration time of CVC insertion using POC US
time frame: 6 months
Number of CVC insertion complications using POC US
time frame: 6 months
Sensitivity (score-the device's ability to identify a condition correctly) of POC US in detection of CVC insertion complications
time frame: 6 months
Specificity (score-the device's ability to exclude a condition correctly) of POC US in detection of CVC insertion complications
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter and for the Detection of Complications
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Soroka University Medical Center.