SCD Fluid Bolus

IDEs can be foregone if any of the exemption criteria at 21 CFR 812.2(c) (Investigational Device Exemptions 2014) are met. [...] A diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and if the testing: is non-invasive, does not introduce energy into the patients body, has the diagnosis confirmed by a medically accepted alternate method.

Study Design

Inclusion Criteria

• A-line
• GA with paralysis
• NSR
• Positive pressure ventilation

Exclusion Criteria

• LIMITS mnemonic
  • Low HR/RR ratio
  • Irregular rhythm
  • Mechanical ventilation w/ low VT
  • Increased intra-abdominal pressure (e.g. insufflation)
  • Thorax Open
  • Spontaneously breathing
• Cardiogenic pulmonary edema
• Tricuspid regurgitation
• Common adverse effects of both compression stockings and IPC include skin pressure injury, pruritus (itching) and discomfort; and both are contraindicated in people with severe peripheral arterial disease (PAD) [16, 17, 18]. IPC is also contraindicated in people with lower‐limb ischaemia, active skin infection, and active DVT or pulmonary embolism [14, 19]. source

SCD hemodynamic effects

Ovid MEDLINE(R) ALL <1946 to November 10, 2026>

1. (pneumatic sleeve or graduated compression stockings or mechanical thromboprophylaxis or sequential compression device).mp. or Intermittent Pneumatic Compression Devices/ (n=1479)
2. (Passive leg raise or Pulse pressure variation or PPV or volume status or fluid challenge or fluid bolus or fluid responsive*).mp. or Hemodynamics/ or Cardiac Output/ or Fluid Therapy/ or Hypotension/ or Stroke Volume/ or Hypovolemia/ or Dehydration/ or Blood Pressure/ (n=587742)
3. 1 and 2 (n=80)
4. from 3 keep 2-3,5-6,8,10,12,16-17,21,23-24,30,32-33,35,37,42,44,48-50,52,56,58,62,69,73-75 (n=30)

Caption text

Reference	Population	Intervention	Comparator	Outcome
Moady et al IMAJ 2019	Healthy volunteers and HFrEF patients	Pneumatic sleeve (PS) compression devices applied to both legs from toe to thigh and inflated to a pressure of 50 or 80 mmHg. the same method does not exacerbate symptoms and increases CO via an increase in SV, decreases SVR, and has no effect on HR (see ref 17).	Example	In healthy volunteers, there was increased CO, decrease SVR, and have no effect on HR (see ref 16). HFrEF patients who were medically optimized had no change in any hemodynamic parameter after 60 minutes of PS application, and that they tolerated it well without any increase in their BNP.
Bickel et al J of Card Failure 2014	Patients with HFrEF (mean LVEF 30%)	ISPC devices applied to both legs and cycled every 2 min for 40 min.	Example	Increased CO, SV, and decreased SVR w/o any effect on HR and without causing signs or symptoms of heart failure exacerbation. CVP and atrial size increased during ISPC activation.
Gibbons et al Experimental Physiology 2019	14 healthy university students	Four 3 minute trials of orthostatic maneuvers (stand-to-squat or thigh cuff compression/release) were done in random order with half of the trials involving ISPC (5 cuffs, peristaltic motion, applied over 200 ms, 65 mmHg, timed to local diastolic phase) of the lower extremity timed to counteract orthostatic changes (return to standing or after thigh-cuff release). Hemodynamic parameters (superficial femoral artery, MAP, Doppler ultrasound cardiac output, total peripheral resistance, middle cerebral artery blood velocity (MCAv), and cerebral tissue saturation index) were measured non-invasively before, during, and after	Example	Decreased TPR, heart rate; increased CO (via increased SV), TSI, and MCAv
Helmi et al Future Cardiology 2013	Example	Example	Example	Example
Kiefer et al Anesthesiology 2011	Example	Example	Example	Example
Kwak et al J of Neurosurgical Anesthesiology 2011	Example	Example	Example	Example
Kwak et al Arthroscopy 2010	Example	Example	Example	Example
Fanelli et al J of Clin Anesthesia 2008	Example	Example	Example	Example
Sohn et al Circulation J 2008	Example	Example	Example	Example
Homdee et al Scientific Reports 2026	12 healthy volunteers	Simultaneous 50 mmHg, 30 mmHg, or intermittent 30 mmHg via IPCDs		Simultaneous 30 mmHg led to the greatest increase in Peak Systolic Velocity (PSV) in the common femoral vein as measured by doppler US, while intermittent led to a slower PSV but longer augmentation, potentially equating to greater total venous return.
Yao et al, IJOA, 2026	26 healthy women undergoing elective CD with spinal anesthesia	Unblinded, RCT, IPC initiation at time of spinal	No IPCs	Phenylephrine rate and incidence of hypotension were lower in the IPC group, but the total dose was not different (though it trended to favor IPC).