Central Line Study
ConditionShock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
Two different techniques for placing a central venous catheter will be compared. The studyu team hypothesizes that clinicians randomized to the peripheral catheter technique will have higher first attempt success rates, fewer procedural complications, and a shorter mean time to procedure completion than physicians assigned to wire through hollow bore needle.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Inherited, acquired, or medication related coagulopathy or thrombocytopenia (platelets < 100,000). Patients will not be excluded for use of aspirin or other anti-platelet medication.
Previous central venous access at the same anatomical site.
Any indwelling catheter or wire that could potentially interfere with central line placement
Anterior border of the target vein deeper than 3.5cm
Trial design
Design model
Parallel
Treatments tested in this trial
Central venous catheter insertion
Procedure/SurgeryThe clinical team will use the technique to establish central venous access
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Standard techniqueActive comparator 1 intervention
Group B: Peripheral IVExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Only 1 attempt
The frequency with which the central line can be placed with only one attempt will be summarized. Each attempt is defined by skin penetration
Time frame
20 minutesSecondary outcomes
1
Unable to place central line
The frequency with which the clinical team is unable to place the central line at that clinical site using the assigned technique will be summarized by study arm.
Time frame
20 minutes2
Number of attempts
Total number of required attempts (skin penetration) will be summarized by study arm.
Time frame
20 minutes3
Number of attempted guidewire passages
Total number of attempted guidewire passages, defined as the number of times a guidewire must be attempted to be passed, will be determined. Results will be summarized by study arm.
Time frame
20 minutes4
Time taken for completion of the procedure
The duration of time from skin penetration to wire out will be summarized by study arm using basic descriptive statistics.
Time frame
20 minutesSponsors and contacts
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Source ClinicalTrials.gov