Fluid Responsiveness in Spontaneously Ventilating Patient

NCT04574011 | Unknown DMC

• 1 other identifier: H-2010-013-1161
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if non-invasive dynamic parameters can predict fluid responsiveness in spontaneous breathing patients.

Conditions

Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

• ClearSight PPV

  Pulse pressure variation measured by ClearSight System arterial waveform

  before induction, 20 minutes

Secondary Outcomes (5)

• ClearSight SVV

  before induction, 20 minutes

• normal ventilation △IVC (inferior vena cava) diameter

  before induction, 20 minutes

• augmented ventilation △IVC (inferior vena cava) diameter

  before induction, 20 minutes

• normal ventilation △POP (pulse oximeter plethysmography)

  before induction, 20 minutes

• augmented ventilation △POP (pulse oximeter plethysmography)

  before induction, 20 minutes

Study Arms (2)

Fluid challenge responder

EXPERIMENTAL

If the ratio of the stroke volume change after passive leg raising is the same or larger than 10%, the patient is assigned to RESPONDER group.

Diagnostic Test: Passive leg raising

Fluid challenge non-responder

EXPERIMENTAL

If the ratio of the stroke volume change after passive leg raising is less than 10%, the patient is assigned to RESPONDER group.

Diagnostic Test: Passive leg raising

Interventions

Passive leg raising DIAGNOSTIC_TEST

Raise the patient's lower limb at a 45 degree angle while lying down

Fluid challenge non-responder; Fluid challenge responder

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for patients undergoing surgery under actual spinal anesthesia whose estimated blood loss during surgery is moderate to high (e.g. total knee arthroplasty, total hip arthroplasty)
• Patients with a history of cerebrovascular disease
• Patients with a history of 1 or 2 vessel disease
• Left ventricle ejection fraction (LVEF) Patients with 30% or more and less than 55% of these patients
• Patients who need close hemodynamic monitoring during operation
• ASA (American Society of Anesthesiology) physical status classification system I, II, III
• no difficulty in passive leg raising maneuver

You may not qualify if:

• Patients unable to communicate
• Patients who cannot or have difficulty in PLR (passive leg raising) maneuver (patients who cause pain when performing PLR due to trauma of the lower extremities, patients with spine disease that causes pain during PLR, and patient applying splint due to a fracture of the lower extremity)
• Patients unable to attach the finger cuff of the ClearSight sytem to one of the fingers of both hands. (Patients applying a splint due to a fracture of both upper limbs, etc.)
• Patients unable to perform transthoracic ultrasound examination (multiple trauma patients with rib fracture, etc.)
• Patients having difficulty obtaining blood pressure waveforms through the ClearSight system due to poor peripheral vascular perfusion (uncontrolled diabetes patients, patients with peripheral vascular disease, etc.)
• Patients with arrhythmia with moderate or higher risk such as atrial fibrillation or atrial flutter
• Heart failure patients with less than 30% of the left ventricular ejection fraction(LVEF) on echocardiography or patients with moderate to severe left ventricular wall motor dysfunction, or patients with cardiovascular disease of 3 vessel disease
• Other patients who are not appropriate to participate in the study as judged by the researcher

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongro-gu, 03080, South Korea

Location

Related Publications (7)

• Cavallaro F, Sandroni C, Antonelli M. Functional hemodynamic monitoring and dynamic indices of fluid responsiveness. Minerva Anestesiol. 2008 Apr;74(4):123-35. Epub 2008 Jan 24.

  PMID: 18212731 BACKGROUND

• Drvar Z, Pavlek M, Drvar V, Tomasevic B, Baronica R, Peric M. [Stroke volume and pulse pressure variation are good predictors of fluid responsiveness in sepsis patients]. Acta Med Croatica. 2013 Dec;67(5):407-14. Croatian.

  PMID: 24979881 BACKGROUND

• Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.

  PMID: 25230102 BACKGROUND

• Slagt C, Malagon I, Groeneveld AB. Systematic review of uncalibrated arterial pressure waveform analysis to determine cardiac output and stroke volume variation. Br J Anaesth. 2014 Apr;112(4):626-37. doi: 10.1093/bja/aet429. Epub 2014 Jan 14.

  PMID: 24431387 BACKGROUND

• Vos JJ, Poterman M, Salm PP, Van Amsterdam K, Struys MM, Scheeren TW, Kalmar AF. Noninvasive pulse pressure variation and stroke volume variation to predict fluid responsiveness at multiple thresholds: a prospective observational study. Can J Anaesth. 2015 Nov;62(11):1153-60. doi: 10.1007/s12630-015-0464-2. Epub 2015 Sep 3.

  PMID: 26335905 BACKGROUND

• Thiel SW, Kollef MH, Isakow W. Non-invasive stroke volume measurement and passive leg raising predict volume responsiveness in medical ICU patients: an observational cohort study. Crit Care. 2009;13(4):R111. doi: 10.1186/cc7955. Epub 2009 Jul 8.

  PMID: 19586543 BACKGROUND

• Chaves RCF, Correa TD, Neto AS, Bravim BA, Cordioli RL, Moreira FT, Timenetsky KT, de Assuncao MSC. Assessment of fluid responsiveness in spontaneously breathing patients: a systematic review of literature. Ann Intensive Care. 2018 Feb 9;8(1):21. doi: 10.1186/s13613-018-0365-y.

  PMID: 29427013 BACKGROUND

Study Officials

• Jintae Kim, M.D

  SNUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngwon Kim, M.D

CONTACT

82-2072-3283; youngwon.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 5, 2020
• Study Start: March 5, 2021
• Primary Completion: June 11, 2021
• Study Completion: July 21, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)