N/A
N=160
Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Patients?
Fluid Overload · Anesthesia; Adverse Effect, Spinal and Epidural · Regional Anesthesia Morbidity
Bottom Line
View on ClinicalTrials.gov: NCT02271477 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Rate of Arterial Hypotension — 42.5; 27.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound-guided volemic repletion (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Arterial Hypotension |
42.5; 27.5 | — |
| SECONDARY Total Amount of IV Fluid at the End of the Procedure |
350; 665 | — |
| SECONDARY Percentage of Participants Administered Vasoactive Drug |
13.51; 6.49 | — |
| SECONDARY Time of Procedures |
22; 24 | — |
Summary
Aim of this study is to determine whether Inferior Vena Cava analyzed by trans-thoracic echocardiography is an effective method to guide titrated fluid repletion in non critical patients, in order both to decrease post procedural significant hypotension rate and to avoid unnecessary fluid overload in patients undergoing spinal anesthesia for elective surgical procedures
Eligibility Criteria
Inclusion Criteria
- both sexes
- grater than 18 year old
- requiring spinal anesthesia
- classified according to American Society of Anesthesiology (ASA) level as 1, 2 or 3
Exclusion Criteria
- patients required invasive blood pressure monitoring (arterial/pulmonary catheter, thermodilution catheter),
- patients show signs of pre-procedural hypotension (defined as two measurements of systolic arterial pressure less than 80 mmHg and/or mean arterial pressure less than 60 mmHg),
- patients unable to give informed consent to language barriers, mental retard or any reduction in own ability to understand or give their informed consent,
- patient in which is not possible to perform spinal anesthesia for patient's refusal or technical difficulties in sampling,
- patients with International Normalized Ratio (INR) greater than 1.5 and/or activated Partial Thrombin Time in therapeutic range (more than 1.5 - 2 times the patient's normal values) and/or anti-factor X activity in therapeutic range
- patients with thrombocytopenia less than 50 G/l.
Data sourced from ClinicalTrials.gov (NCT02271477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.