Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06466226 |
| Other study ID # |
75871523.2.0000.5530 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
December 31, 2027 |
Study information
| Verified date |
June 2024 |
| Source |
Hospital Nossa Senhora da Conceicao |
| Contact |
Andre P Schmidt, MD |
| Phone |
555133572419 |
| Email |
aschmidt[@]ghc.com.br |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patients at risk of significant intraoperative blood loss and/or 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, pneumothorax/hemothorax, 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.
Description:
Patients at risk of significant intraoperative blood loss and/or 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, pneumothorax/hemothorax, 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, pneumothorax/hemothorax, 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 and/or 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 and/or 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
(i.e., 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.
