Abdominal Surgery Clinical Trial
— AFMOfficial title:
A Validation of the Assisted Fluid Management Feature
Verified date | May 2019 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
Status | Completed |
Enrollment | 330 |
Est. completion date | January 25, 2019 |
Est. primary completion date | December 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Be = 18 years of age - Abdominal, pelvic, major peripheral vascular surgery expected to last >2 hours post anesthesia induction - Participate or have authorized representative participate in the Informed Consent process and sign/date the IRB approved informed consent form. Exclusion Criteria: - Are < 18 years of age - Emergent or cardiovascular surgical procedure - Are pregnant - Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Clinical Study) - Refusal of patient or authorized representative to sign consent |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | The University of Texas Southwestern at Clements | Dallas | Texas |
United States | Duke University | Durham | North Carolina |
United States | Greenville Health System, Greenville Memorial Hospital | Greenville | South Carolina |
United States | Loma Linda Health University | Loma Linda | California |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | University of California, Davis | Sacramento | California |
United States | Stony Brook Medicine | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences |
United States,
Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-44. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of the Assisted Fluid Management Feature: Stroke volume change meeting the clinician-selected fluid strategy | Stroke volume change meeting the clinician-selected fluid strategy | 30 Day follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01611376 -
Impedance Cardiography During Major Abdominal Surgery
|
Phase 4 | |
Recruiting |
NCT05556174 -
Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
|
N/A | |
Completed |
NCT03633123 -
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
|
Phase 2 | |
Terminated |
NCT03684304 -
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery
|
N/A | |
Active, not recruiting |
NCT02817893 -
Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
|
N/A | |
Completed |
NCT04120740 -
Validation of Two Acitivity Monitors in Three Inpatient Populations.
|
||
Recruiting |
NCT03700749 -
FALCON Trial Testing Measures to Reduce Surgical Site Infection
|
Phase 3 | |
Completed |
NCT01389648 -
Pre-operative Physiotherapy to Prevent Post-operative Complications
|
N/A | |
Withdrawn |
NCT00557843 -
Continuous Bupivacaine Infusion Following Colonic Surgery
|
N/A | |
Active, not recruiting |
NCT01839617 -
Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery
|
N/A | |
Terminated |
NCT04887922 -
Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
|
N/A | |
Completed |
NCT04730141 -
Effect of Mobilization Protocol on Mobilization
|
N/A | |
Completed |
NCT00683150 -
Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring
|
N/A | |
Active, not recruiting |
NCT03933306 -
Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes
|
Phase 4 | |
Recruiting |
NCT05268432 -
Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
|
||
Not yet recruiting |
NCT04747535 -
Continuous Positive Airway Pressure After Abdominal Surgery
|
N/A | |
Not yet recruiting |
NCT05253586 -
Versius Or Laparoscopic Abdominal Hernia REpair
|
||
Recruiting |
NCT06374849 -
Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
|
Phase 4 | |
Recruiting |
NCT05246605 -
Postoperative Hypoxia and Body Position
|
N/A | |
Recruiting |
NCT04685876 -
Comparing TAP Blocks Bupivacaine, and Placebo for Plane
|
Phase 3 |