Perioperative Hemodynamic Optimization Using the NICOM Device

Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01217151

Enrollment

142

Registered

2010-10-08

Start date

2011-01-31

Completion date

2012-11-30

Last updated

2012-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Abdominal Surgery

Keywords

Hemodynamic Monitoring, Goal-Directed Therapy

Brief summary

In the last years, there is a growing interest in the improvement of prognosis and shortening of hospital length of stay in high-risk surgical patients. Several evidence-based protocols (fast-track surgery) have been developed and implemented in some hospitals for this purpose. Cardiovascular optimization through the so-called goal-directed therapy (GDT) is a key element in these protocols. Previous studies in the literature use invasive monitors to assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical scenarios. The aim of the present randomized, international, multi-center, open-label clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial pressure) to test the hypothesis that GDT is superior to standard practice in terms of reduction in the incidence of perioperative complications and length of hospital stay in high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24 hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and mortality will be analysed. All patients will be followed from the day of surgery up to hospital discharge (determined by a specialist surgeon not involved in the study) or death.

Interventions

DEVICEHemodynamic monitoring

Hemodynamic monitoring based on the NICOM device

OTHERUsual treatment

Hemodynamic monitoring based on common practice

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Adult patients scheduled for: * Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection. * Gastrectomy. * Small bowel resection. * Signed written informed consent.

Exclusion criteria

* Less than 18 years old. * Laparoscopic procedure. * Emergency surgery. * Intra-abdominal infection. * Patients not requiring ICU admission (patients should stay for at least the first day at the ICU). * Life expectancy lower than 60 days. * Disseminated malignancy.

Design outcomes

Primary

Measure	Time frame
Decrease in hospital length of stay	Three months

Secondary

Measure	Time frame	Description
Time to peristalsis recovery	Three weeks	Peristalsis shall be assessed by first flatus after abdominal surgery
Incidence of wound infection	Three weeks	—
Incidence of anastomotic leaks	Three weeks	—
Any cause mortality	Three months	—

Countries

Israel, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026