Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466226
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-17
Brief Title:
Complications Associated With Multiple Central Venous Accesses in the Internal Jugular Vein
Sponsor:
Hospital Nossa Senhora da Conceicao
Organization:
Hospital Nossa Senhora da Conceicao
Study Overview
Official Title:
Incidence of Complications Associated With Multiple Central Venous Accesses in the Internal Jugular Vein a Randomized Multicenter Non-inferiority Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients at risk of significant intraoperative blood loss andor potential hemodynamic instability often necessitate the placement of two or more central venous catheters including large bore catheters In tertiary hospitals anesthesiologists frequently encounter patients undergoing major surgeries such as liver transplantation lung transplantation cardiac surgery and vascular surgery who require multiple central venous punctures as part of routine anesthetic management However most review and consensus articles do not directly address the utilization of multiple catheters in the same venous site nor establish formal recommendations regarding this practice The latest consensus on central venous access from the American Association of Anesthesiologists ASA published in 2012 briefly touches upon some aspects related to this practice but does not outline any contraindications Thus the investigators have identified a gap in evidence and robust prospective studies addressing the use of more than one catheter in the same site for central venous access This lacuna underscores the importance of conducting a controlled clinical study in our institutions to establish the efficacy and safety of this approach in the perioperative context The present study aims to evaluate the incidence of mechanical complications such as dysrhythmias arterial puncture hematoma pneumothoraxhemothorax insertion failure or inadequate positioning within the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels in patients undergoing multiple central venous accesses during major surgeries This study will be designed as a prospective randomized non-inferiority open parallel clinical trial with two groups for patient allocation Patients identified for multiple central venous accesses as part of preoperative anesthetic planning will be randomly allocated to either receive two central venous accesses in two separate sites Group I or control group or two concurrent central venous accesses in a single internal jugular vein Group II or intervention group Only adult patients classified as ASA I to IV over 18 years old scheduled for major surgery will be eligible for inclusion
Detailed Description:
Patients at risk of significant intraoperative blood loss andor potential hemodynamic instability often necessitate the placement of two or more central venous catheters including large bore catheters In tertiary hospitals we frequently encounter patients undergoing major surgeries such as liver transplantation lung transplantation cardiac surgery and vascular surgery who require multiple central venous punctures as part of routine anesthetic management However most review and consensus articles do not directly address the utilization of multiple catheters in the same venous site nor do they establish formal recommendations regarding this practice The latest consensus on central venous access from the American Association of Anesthesiologists ASA published in 2012 briefly touches upon some aspects related to this practice but does not outline any contraindications This consensus primarily references the only comparative and prospective study conducted by Reeves and colleagues in 1995 which compared the passage of multiple central venous catheters in a single site right internal jugular vein with placements in different sites
Thus the investigators have identified a gap in evidence and robust prospective studies addressing the use of more than one catheter in the same site for central venous access This lacuna underscores the importance of conducting a controlled clinical study in our institutions to establish the efficacy and safety of this approach in the perioperative context
Our study aims to evaluate the incidence of mechanical complications such as dysrhythmias arterial puncture hematoma pneumothoraxhemothorax insertion failure or inadequate positioning within the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels in patients undergoing multiple central venous accesses during major surgeries
The study will be designed as a prospective randomized non-inferiority open parallel clinical trial with two groups for patient allocation Patients identified for multiple central venous accesses as part of preoperative anesthetic planning will be randomly allocated to either receive two central venous accesses in two separate sites Group I or control group or two concurrent central venous accesses in a single internal jugular vein Group II or intervention group The preferred site for the second central venous access in Group I will be the subclavian vein
Only adult patients classified as ASA I to IV over 18 years old scheduled for major surgery will be eligible for inclusion Surgical procedures considered for patient allocation include cardiac surgeries vascular surgeries major abdominal or thoracic surgeries liver transplants and lung transplants Inclusion criteria specify patients with anesthetic planning for the insertion of at least two central venous catheters
The primary hypothesis of this study is that the incidence of mechanical complications cardiac arrhythmias arterial puncture hematoma pneumothoraxhemothorax catheter insertion failure or inadequate catheter positioning is equivalent with two punctures in the internal jugular vein when compared to punctures in two different central vessels internal jugular vein and subclavian andor femoral vein
The secondary hypotheses of this study are that the incidence of catheter-related infection catheter malfunction and puncture site thrombosis is lower with two punctures in the internal jugular vein when compared to punctures in two different central vessels internal jugular vein and subclavian andor femoral
The study will be designed as a prospective randomized non-inferiority open parallel clinical trial with two groups for patient allocation Patients who according to preoperative anesthetic planning have indications for multiple central venous accesses ie patients with indications for 2 concomitant central venous catheters will be randomly allocated to two central venous accesses in two sites separately Group I or control group or two concomitant central venous accesses in a single internal jugular vein Group II or intervention group The preferred site for the second group I central venous access is the subclavian
In this study adult patients scheduled to undergo major surgery at the Hospital de Clínicas de Porto Alegre Santa Casa de Porto Alegre and Hospital Nossa Senhora da Conceição will be included All hospitals involved will have equivalent importance varying participation according to the number of surgeries performed in the institutions
Only adult ASA I to IV patients over 18 years old scheduled to undergo major surgery in the aforementioned hospitals will be included
The surgical procedures considered in this study for patient allocation include cardiac surgeries vascular surgeries major abdominal or thoracic surgeries liver transplants and lung transplants Only patients with anesthetic planning for insertion of at least two central venous catheters will be included
Thus the investigators have identified a gap in evidence and robust prospective studies addressing the use of more than one catheter in the same site for central venous access This lacuna underscores the importance of conducting a controlled clinical study in our institutions to establish the efficacy and safety of this approach in the perioperative context
Our study aims to evaluate the incidence of mechanical complications such as dysrhythmias arterial puncture hematoma pneumothoraxhemothorax insertion failure or inadequate positioning within the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels in patients undergoing multiple central venous accesses during major surgeries
The study will be designed as a prospective randomized non-inferiority open parallel clinical trial with two groups for patient allocation Patients identified for multiple central venous accesses as part of preoperative anesthetic planning will be randomly allocated to either receive two central venous accesses in two separate sites Group I or control group or two concurrent central venous accesses in a single internal jugular vein Group II or intervention group The preferred site for the second central venous access in Group I will be the subclavian vein
Only adult patients classified as ASA I to IV over 18 years old scheduled for major surgery will be eligible for inclusion Surgical procedures considered for patient allocation include cardiac surgeries vascular surgeries major abdominal or thoracic surgeries liver transplants and lung transplants Inclusion criteria specify patients with anesthetic planning for the insertion of at least two central venous catheters
The primary hypothesis of this study is that the incidence of mechanical complications cardiac arrhythmias arterial puncture hematoma pneumothoraxhemothorax catheter insertion failure or inadequate catheter positioning is equivalent with two punctures in the internal jugular vein when compared to punctures in two different central vessels internal jugular vein and subclavian andor femoral vein
The secondary hypotheses of this study are that the incidence of catheter-related infection catheter malfunction and puncture site thrombosis is lower with two punctures in the internal jugular vein when compared to punctures in two different central vessels internal jugular vein and subclavian andor femoral
The study will be designed as a prospective randomized non-inferiority open parallel clinical trial with two groups for patient allocation Patients who according to preoperative anesthetic planning have indications for multiple central venous accesses ie patients with indications for 2 concomitant central venous catheters will be randomly allocated to two central venous accesses in two sites separately Group I or control group or two concomitant central venous accesses in a single internal jugular vein Group II or intervention group The preferred site for the second group I central venous access is the subclavian
In this study adult patients scheduled to undergo major surgery at the Hospital de Clínicas de Porto Alegre Santa Casa de Porto Alegre and Hospital Nossa Senhora da Conceição will be included All hospitals involved will have equivalent importance varying participation according to the number of surgeries performed in the institutions
Only adult ASA I to IV patients over 18 years old scheduled to undergo major surgery in the aforementioned hospitals will be included
The surgical procedures considered in this study for patient allocation include cardiac surgeries vascular surgeries major abdominal or thoracic surgeries liver transplants and lung transplants Only patients with anesthetic planning for insertion of at least two central venous catheters will be included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None