Hemodynamic Instability
Conditions
Keywords
Open Abdominal Surgical Procedure
Brief summary
The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids.
Detailed description
Electronic and annotated observation data to support an algorithm library
Interventions
PROCEDUREInitial bolus pre-incision
Measured hemodynamic response to pre-incision bolus
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥18 years booked for an open abdominal procedure 2. American Society of Anaesthesiologists (ASA) Physical Status 1 - 3 3. Expected duration of surgical procedure to be ≥ 2 hours 4. Standard of care monitoring to include cardiac output
Exclusion criteria
1. Open chest surgical procedure expected 2. Cardiac arrhythmia such as atrial fibrillation. 3. Right Ventricular Failure 4. Aortic regurgitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Hemodynamic Response to Fluid Resuscitation | Up to 6 hours but not to exceed duration of surgical procedure | Physiological parameters compared before and after fluid bolus for fluid resuscitation. |
Countries
United States
Participant flow
Recruitment details
Patients meeting the inclusion and exclusion criteria were recruited in the pre-op clinic. Recruitment started on 15-AUG-2014 with ended in January 2015.
Participants by arm
| Arm | Count |
|---|---|
| Initial Bolus Pre-incision Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded
Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Initial Bolus Pre-incision |
|---|---|
| Age, Continuous | 58 years |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 2 / 18 |
Outcome results
Primary
Dynamic Hemodynamic Response to Fluid Resuscitation
Physiological parameters compared before and after fluid bolus for fluid resuscitation.
Time frame: Up to 6 hours but not to exceed duration of surgical procedure
Population: Reference devices were in disagreement so the algorithm could not be verified