[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05534971":3,"trial-entities:NCT05534971":100,"trial-summary:NCT05534971":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":69,"locations":72,"central_contacts":86,"overall_officials":94,"references":98,"see_also_links":99},"NCT05534971","2022-14157","Central Line Study","A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion","RECRUITING","2027-12","2026-01","2026-01-06","2022-11-16","Montefiore Medical Center","OTHER",true,"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.","Central venous catheterization (CVC) is a lifesaving procedure carried out by emergency and acute care physicians to access proximal blood vessels in order to deliver medications, blood products and other resuscitative agents. Typically, this access is achieved by threading a wire through a hollow bore needle and then placing the central venous catheter over the wire. This procedure, called the Seldinger technique, results in the cannulation of the femoral or internal jugular veins. Nowadays, physicians use concurrent ultrasound guidance rather than an anatomic landmark-based approach to increase the success rate of central venous catheterization. The wire through hollow bore needle approach requires the use of two hands to hold the needle in the vessel in order to pass a guidewire. When done under ultrasound guidance, this requires dropping the ultrasound probe in order to have both hands available to achieve vessel cannulation.\n\nRecent research has demonstrated that cannulation of central veins can be obtained by first using a peripheral intravenous catheter rather than a hollow bore needle. This technique requires just one hand, thereby allowing the physician to continue use of the ultrasound. Furthermore, the peripheral intravenous catheter is more stable within the vein than the hollow bore needle and less likely than the needle to damage the vessel wall when the catheter is jiggled. This is the same technique used to place mid-lines, a hybrid technique that incorporates the Seldinger technique and a peripheral intravenous catheter.",[19],"Shock",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},160,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Central venous catheter insertion","The clinical team will use the technique to establish central venous access",[34,35],"Peripheral IV","Standard technique",[37],{"measure":38,"description":39,"timeFrame":40},"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","20 minutes",[42,45,48,51,54],{"measure":43,"description":44,"timeFrame":40},"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.",{"measure":46,"description":47,"timeFrame":40},"Number of attempts","Total number of required attempts (skin penetration) will be summarized by study arm.",{"measure":49,"description":50,"timeFrame":40},"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.",{"measure":52,"description":53,"timeFrame":40},"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.",{"measure":55,"description":56,"timeFrame":40},"Procedure-related adverse events","Procedure related adverse events including pneumothorax, incorrect vessel cannulation, and bleeding requiring application of pressure will be summarized by study arm.","ALL","18 Years",null,false,{"inclusion":62,"exclusion":63,"raw_text":68},[],[64,65,66,67],"Inherited, acquired, or medication related coagulopathy or thrombocytopenia (platelets \\\u003C 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","Inclusion Criteria:\n\nAdult patients in the emergency department who require ultrasound guided central line placement are eligible for participation and will be referred for participation in the study by the clinical team.\n\nExclusion Criteria:\n\n* Inherited, acquired, or medication related coagulopathy or thrombocytopenia (platelets \\\u003C 100,000). Patients will not be excluded for use of aspirin or other anti-platelet medication.\n* Previous central venous access at the same anatomical site.\n* Any indwelling catheter or wire that could potentially interfere with central line placement\n* Anterior border of the target vein deeper than 3.5cm\n\nOr for any clinical feature that would interfere with obtaining informed consent including dementia, delirium, or encephalopathy, as determined by the clinical attending physician.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":83},"Montefiore","The Bronx","New York","10467","United States",[80],{"name":81,"role":82},"Benjamin Friedman, MD","CONTACT",{"lat":84,"lon":85},40.84985,-73.86641,[87,91],{"name":88,"role":82,"phone":89,"email":90},"Joe Offenbacher, MD","646-929-7815","joseph.offenbacher@nyulangone.org",{"name":81,"role":82,"phone":92,"email":93},"718-920-6626","bfriedm@montefiore.org",[95],{"name":96,"affiliation":13,"role":97},"Benjamin J Friedman, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[19],[],{"nct_id":4,"found":15,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional study comparing two different techniques for central line placement. Approximately 160 adult participants will be involved.","completed","Comparing Central Line Placement Techniques for Shock Patients","This study is comparing two ways to insert a central venous catheter (a thin tube placed into a large vein, often in the neck, chest, or groin, to give fluids or medicine quickly) in adults who are in the emergency department and need one due to shock. Researchers want to see if using a peripheral catheter first, instead of a hollow needle, leads to more successful first attempts, fewer problems, and a faster procedure. You could be eligible if you are an adult in the emergency department needing an ultrasound-guided central line, unless you have certain blood clotting issues. The main goal is to see how many attempts it takes to successfully place the central line within 20 minutes. The study is currently recruiting about 160 participants, but its overall status is unclear.","The primary outcome is measured at 20 minutes, which is the timeframe for assessing the success of the first attempt.",133,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]