search
Back to results

Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.

Primary Purpose

Hypotension, Fluid Overload

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Inferior venacava Ultrasonography (IVC USG) guided fluid management
Sponsored by
Tribhuvan University, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Collapsibility index, Inferior venacava ultrasound, Spinal anesthesia, Transthoracic echocardiography

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥16-65 years
  2. American Society of Anaesthesiology physical status (ASA PS) I and II
  3. Requiring elective spinal anaesthesia for lower limb orthopaedic surgery

Exclusion Criteria:

  1. Patients with pre-procedural hypotension, defined as two consecutive measurements of systolic arterial pressure (SAP) less than 90 mmHg or mean arterial pressure (MAP) less of 60 mmHg.
  2. Contraindication for Spinal Anaesthesia

    • Platelet counts ˂100,000 per microlitre of blood
    • International normalized ratio (INR) ≥1.5
    • Bleeding disorders
    • Infection at injection site

Sites / Locations

  • Semanta Dahal

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

USG arm

Arm Description

Control group will follow the standard procedure in our centre and will not undergo USG assessment before spinal anaesthesia. The spinal anaesthesia procedure will be standardized. Under strict aseptic precautions spinal anesthesia will be performed at L3-L4 inter-space using a 25 Gauge Quincke spinal needle (B. Braun Medical SA, Melsungen, Germany) in sitting position. 3 ml of hyperbaric bupivacaine 0.5% (15 mg) will be injected with the needle orifice oriented cranially. After injection, patients will be immediately positioned supine. Meanwhile, the non-invasive blood pressure will be measured and recorded every 3 minute for 30 min and then every 5 min throughout surgery and anesthesia.

In the IVC USG group, USG assessment and volume optimisation using collapsibility index will be done prior to spinal anaesthesia. all patients will be lying supine, for at least 5 min before IVC examination. Ultrasound measurements will be performed using a Sonosite M-Turbo (Sonosite Inc., USA) machine and phased array 5-1 Megahertz transducer (Sonosite Inc.) set to abdominal mode by an M-mode modality through the subcostal view. All IVC measurements will be performed by principal investigator before spinal anaesthesia. Principal investigator should have performed more than 25 scans before the commencement of the study.

Outcomes

Primary Outcome Measures

Comparison of incidence of hypotension between two groups
To compare the incidence of hypotension after spinal anesthesia between two groups, USG group who have undergone volemic optimization after USG assessment and control group.

Secondary Outcome Measures

Analyse amount of fluids administered between two groups
To compare fluid adjustment requirement between USG group and control group
Compare vasopressors used between two groups
To compare the rate of vasopressors used between USG group and control group

Full Information

First Posted
January 29, 2021
Last Updated
February 3, 2021
Sponsor
Tribhuvan University, Nepal
Collaborators
Tribhuvan University
search

1. Study Identification

Unique Protocol Identification Number
NCT04736498
Brief Title
Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.
Official Title
Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tribhuvan University, Nepal
Collaborators
Tribhuvan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypotension is common during spinal anesthesia and contributes to underperfusion and ischemia. Severe episodes of intraoperative hypotension is an independent risk factor for myocardial infarction, stroke, heart failure, acute kidney injury, prolonged hospital stay and increased one year mortality rates. Empiric fluid preloading can be done to decrease the incidence of hypotension but carries risk of fluid overload especially in elderly and cardiac patients. Inferior venacava ultrasonography (IVC USG) has been used in spontaneously breathing critically ill patients for volume responsiveness but there is limited data regarding its use for volume optimization in perioperative setting. The aim of this study is to evaluate the use of inferior venacava ultrasound to guide fluid management for prevention of hypotension after spinal anesthesia.
Detailed Description
Introduction: Hypotension is common during spinal anesthesia and contributes to underperfusion and ischemia. It occurs due to reduction in both cardiac output and systemic vascular resistance. Even short duration of intraoperative MAP less than 55 mmHg has been found to be associated with Acute kidney injury (AKI) and myocardial injury. Severe episodes of intraoperative hypotension is an independent risk factor for myocardial infarction, stroke, heart failure, acute kidney injury, prolonged hospital stay and increased 1 year mortality rates. Predictive variables for spinal anesthesia induced hypotension includes peak sensory level, chronic alcohol consumption, emergency surgery, age more than 40 years, hypertension, combined spinal/general anaesthesia(GA), spinal puncture at or above lumbar 2 lumber 3 (L2L3) interspace. Preoperative volume status is an important factor determining patient's hemodynamic status. Traditional static parameters such as central venous pressure have been criticized for invasiveness and lack of accuracy. Newer noninvasive dynamic parameters like inferior venacava diameter and Collapsibility index(CI), acoustic echocardiography, stroke volume variation and pulse pressure variation etc are being used widely for assessing volume status. Study Objective: To evaluate the use of inferior vena cava ultrasound to guide fluid management for prevention of hypotension after spinal anesthesia. Design: A randomized prospective interventional study Sample size: 92 Place: Operating theatres of Tribhuvan University Teaching Hospital (TUTH), Maharajgunj Medical Campus (MMC), Institute of Medicine (IOM). Interventions: A total of 92 patients undergoing lower limb orthopedic surgery will be enrolled in the study. They will be randomized into USG group and Control group. In the USG group, IVC ultrasound will be done and collapsibility index (CI) will be calculated. Depending upon the value of calculated CI, fluid management will be done by infusing Ringer's Lactate (RL). Thereafter spinal anesthesia will be performed. In the control group, spinal anesthesia will be performed without IVC USG assessment. In both the groups, incidence of hypotension and amount of fluid and vasopressors administered will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Fluid Overload
Keywords
Collapsibility index, Inferior venacava ultrasound, Spinal anesthesia, Transthoracic echocardiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Control group will follow the standard procedure in our centre and will not undergo USG assessment before spinal anaesthesia. The spinal anaesthesia procedure will be standardized. Under strict aseptic precautions spinal anesthesia will be performed at L3-L4 inter-space using a 25 Gauge Quincke spinal needle (B. Braun Medical SA, Melsungen, Germany) in sitting position. 3 ml of hyperbaric bupivacaine 0.5% (15 mg) will be injected with the needle orifice oriented cranially. After injection, patients will be immediately positioned supine. Meanwhile, the non-invasive blood pressure will be measured and recorded every 3 minute for 30 min and then every 5 min throughout surgery and anesthesia.
Arm Title
USG arm
Arm Type
Experimental
Arm Description
In the IVC USG group, USG assessment and volume optimisation using collapsibility index will be done prior to spinal anaesthesia. all patients will be lying supine, for at least 5 min before IVC examination. Ultrasound measurements will be performed using a Sonosite M-Turbo (Sonosite Inc., USA) machine and phased array 5-1 Megahertz transducer (Sonosite Inc.) set to abdominal mode by an M-mode modality through the subcostal view. All IVC measurements will be performed by principal investigator before spinal anaesthesia. Principal investigator should have performed more than 25 scans before the commencement of the study.
Intervention Type
Other
Intervention Name(s)
Inferior venacava Ultrasonography (IVC USG) guided fluid management
Intervention Description
The IVC will be visualized using a paramedian long-axis view via a subcostal approach. A two-dimensional image of the IVC as it enters the right atrium will be first obtained. Variations in IVC diameter with respiration will be assessed using M-mode imaging performed 2 to 3 cm distal to the junction of right atrium and IVC. Maximum and minimum diameter will be measured from inner wall to inner wall and collapsibility index(CI) will be calculated using formula: CI = [(dIVCmax - dIVCmin)/dIVCmax] x 100% CI of ˃36% will be accepted as predicted fluid responder and ≤36% will be regarded as predicted fluid non responders. Predicted fluid responders will receive a bolus of 500 ml of Ringer's lactate over a time period of 15 min, after which the IVC diameter variation will be reassessed. Additional 250ml of Ringer's lactate bolus will be applied until a non fluid responder pattern is observed during IVC USG. Thereafter,spinal anaesthesia will be performed.
Primary Outcome Measure Information:
Title
Comparison of incidence of hypotension between two groups
Description
To compare the incidence of hypotension after spinal anesthesia between two groups, USG group who have undergone volemic optimization after USG assessment and control group.
Time Frame
30 minutes after spinal anaesthesia
Secondary Outcome Measure Information:
Title
Analyse amount of fluids administered between two groups
Description
To compare fluid adjustment requirement between USG group and control group
Time Frame
30 minutes after spinal anaesthesia
Title
Compare vasopressors used between two groups
Description
To compare the rate of vasopressors used between USG group and control group
Time Frame
30 minutes after spinal anaesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥16-65 years American Society of Anaesthesiology physical status (ASA PS) I and II Requiring elective spinal anaesthesia for lower limb orthopaedic surgery Exclusion Criteria: Patients with pre-procedural hypotension, defined as two consecutive measurements of systolic arterial pressure (SAP) less than 90 mmHg or mean arterial pressure (MAP) less of 60 mmHg. Contraindication for Spinal Anaesthesia Platelet counts ˂100,000 per microlitre of blood International normalized ratio (INR) ≥1.5 Bleeding disorders Infection at injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semanta Dahal, MBBS, MD
Organizational Affiliation
Institute of Medicine (IOM), Tribhuvan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semanta Dahal
City
Maharajgunj
State/Province
Bagmati
ZIP/Postal Code
44600
Country
Nepal

12. IPD Sharing Statement

Citations:
PubMed Identifier
9710410
Citation
Wulf HF. The centennial of spinal anesthesia. Anesthesiology. 1998 Aug;89(2):500-6. doi: 10.1097/00000542-199808000-00028. No abstract available.
Results Reference
background
Citation
Brull R, Macfarlane A, Chan V. Spinal, epidural and caudal anesthesia. In: Miller RD, editor. Miller's anesthesia. 8th ed: Elsevier; 2015.
Results Reference
background
PubMed Identifier
1599111
Citation
Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
Results Reference
background
PubMed Identifier
14529003
Citation
Salinas FV, Sueda LA, Liu SS. Physiology of spinal anaesthesia and practical suggestions for successful spinal anaesthesia. Best Pract Res Clin Anaesthesiol. 2003 Sep;17(3):289-303. doi: 10.1016/s1521-6896(02)00114-3.
Results Reference
background
PubMed Identifier
23835589
Citation
Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
Results Reference
background
PubMed Identifier
26181335
Citation
Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
Results Reference
background
PubMed Identifier
27792044
Citation
Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
Results Reference
background
PubMed Identifier
26771910
Citation
Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
Results Reference
background
PubMed Identifier
26083768
Citation
Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756. Erratum In: Anesthesiology. 2016 Mar;124(3):741-2.
Results Reference
background
PubMed Identifier
18813052
Citation
Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.
Results Reference
background
PubMed Identifier
25885825
Citation
Bajwa SJ, Kulshrestha A, Jindal R. Co-loading or pre-loading for prevention of hypotension after spinal anaesthesia! a therapeutic dilemma. Anesth Essays Res. 2013 May-Aug;7(2):155-9. doi: 10.4103/0259-1162.118943.
Results Reference
background
PubMed Identifier
25701927
Citation
Minto G, Scott MJ, Miller TE. Monitoring needs and goal-directed fluid therapy within an enhanced recovery program. Anesthesiol Clin. 2015 Mar;33(1):35-49. doi: 10.1016/j.anclin.2014.11.003.
Results Reference
background
PubMed Identifier
22661747
Citation
Doherty M, Buggy DJ. Intraoperative fluids: how much is too much? Br J Anaesth. 2012 Jul;109(1):69-79. doi: 10.1093/bja/aes171. Epub 2012 Jun 1.
Results Reference
background
PubMed Identifier
21209539
Citation
Singh J, Ranjit S, Shrestha S, Sharma R, Marahatta SB. Effect of preloading on hemodynamic of the patient undergoing surgery under spinal anaesthesia. Kathmandu Univ Med J (KUMJ). 2010 Apr-Jun;8(30):216-21. doi: 10.3126/kumj.v8i2.3562.
Results Reference
background
PubMed Identifier
18628220
Citation
Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331.
Results Reference
background
PubMed Identifier
23302716
Citation
Kalantari K, Chang JN, Ronco C, Rosner MH. Assessment of intravascular volume status and volume responsiveness in critically ill patients. Kidney Int. 2013 Jun;83(6):1017-28. doi: 10.1038/ki.2012.424. Epub 2013 Jan 9.
Results Reference
background
PubMed Identifier
22185905
Citation
Lansdorp B, Lemson J, van Putten MJ, de Keijzer A, van der Hoeven JG, Pickkers P. Dynamic indices do not predict volume responsiveness in routine clinical practice. Br J Anaesth. 2012 Mar;108(3):395-401. doi: 10.1093/bja/aer411. Epub 2011 Dec 20.
Results Reference
background
PubMed Identifier
23043910
Citation
Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.
Results Reference
background
PubMed Identifier
17508199
Citation
Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.
Results Reference
background
PubMed Identifier
28525778
Citation
Corl KA, George NR, Romanoff J, Levinson AT, Chheng DB, Merchant RC, Levy MM, Napoli AM. Inferior vena cava collapsibility detects fluid responsiveness among spontaneously breathing critically-ill patients. J Crit Care. 2017 Oct;41:130-137. doi: 10.1016/j.jcrc.2017.05.008. Epub 2017 May 12.
Results Reference
background
PubMed Identifier
24495437
Citation
Zhang Z, Xu X, Ye S, Xu L. Ultrasonographic measurement of the respiratory variation in the inferior vena cava diameter is predictive of fluid responsiveness in critically ill patients: systematic review and meta-analysis. Ultrasound Med Biol. 2014 May;40(5):845-53. doi: 10.1016/j.ultrasmedbio.2013.12.010. Epub 2014 Feb 2.
Results Reference
background
PubMed Identifier
27749318
Citation
Preau S, Bortolotti P, Colling D, Dewavrin F, Colas V, Voisin B, Onimus T, Drumez E, Durocher A, Redheuil A, Saulnier F. Diagnostic Accuracy of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis and Acute Circulatory Failure. Crit Care Med. 2017 Mar;45(3):e290-e297. doi: 10.1097/CCM.0000000000002090.
Results Reference
background
PubMed Identifier
29564661
Citation
Di Pietro S, Falaschi F, Bruno A, Perrone T, Musella V, Perlini S. The learning curve of sonographic inferior vena cava evaluation by novice medical students: the Pavia experience. J Ultrasound. 2018 Jun;21(2):137-144. doi: 10.1007/s40477-018-0292-7. Epub 2018 Mar 21.
Results Reference
background
PubMed Identifier
31390983
Citation
Szabo M, Bozo A, Darvas K, Horvath A, Ivanyi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4.
Results Reference
background
PubMed Identifier
29397116
Citation
Ceruti S, Anselmi L, Minotti B, Franceschini D, Aguirre J, Borgeat A, Saporito A. Prevention of arterial hypotension after spinal anaesthesia using vena cava ultrasound to guide fluid management. Br J Anaesth. 2018 Jan;120(1):101-108. doi: 10.1016/j.bja.2017.08.001. Epub 2017 Nov 23.
Results Reference
background
PubMed Identifier
30664523
Citation
Salama ER, Elkashlan M. Pre-operative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):297-302. doi: 10.1097/EJA.0000000000000956. Erratum In: Eur J Anaesthesiol. 2019 Nov;36(11):888.
Results Reference
background
PubMed Identifier
17427526
Citation
Chinachoti T, Tritrakarn T. Prospective study of hypotension and bradycardia during spinal anesthesia with bupivacaine: incidence and risk factors, part two. J Med Assoc Thai. 2007 Mar;90(3):492-501.
Results Reference
background

Learn more about this trial

Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.

We'll reach out to this number within 24 hrs