CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 750 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02959203
NCT02959203N/ACompleted

Comparison of Bedside Ultrasound With Chest X-ray to Detect CVC Related Mechanical Complications; a Prospective Observational Study (COMBUX-study)

Amsterdam UMC, location VUmc·observational·Posted Nov 9, 2016·Updated Feb 22, 2018

In Brief

An observational study for Pneumothorax Iatrogenic Postprocedural and Malposition, Central Venous Catheter. Completed, enrolled 750 participants across 1 site.

Detailed Summary

Background: Insertion of a central venous catheter (CVC) could lead to a variety of complications. To detect those complications, Chest X-ray (CXR) is still the reference standard. However, there are major limitations in performing CXR's in the critical care setting. Aim/objectives: The objective of this study is to compare the use of bedside ultrasound (US) to conventional CXR in visualization of accuracy and safety of the CVC placement. The aim is to eventually replace X-ray with bedside ultrasound as gold standard for the confirmation of CVC-placement in critically ill patients, thereby reducing radiation exposure and unnecessary delay before CVC use. Methods: The bedside US will be performed by the student or attending physician, who is blinded for CXR findings. After US examination, the attending physician (or student) will fill in a structured form, based on an established protocol. CXR will be performed before or after US examination and assessed by a radiologist. The radiologist will be blinded for the findings of the bedside ultrasound to prevent any biases. Final diagnosis will be determined after examination of the complete medical chart.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 9, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.6 years ago