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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.
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=Study Design=
 
=Study Design=
 
==Inclusion Criteria==
 
==Inclusion Criteria==
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* NSR
 
* NSR
 
* Positive pressure ventilation
 
* Positive pressure ventilation
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==Exclusion Criteria==
−
==Exclusion Criteria== 
   
* LIMITS [https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-022-01022-8 mnemonic]
 
* LIMITS [https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-022-01022-8 mnemonic]
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* Low HR/RR ratio
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** Low HR/RR ratio
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* Irregular rhythm
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** Irregular rhythm
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* Mechanical ventilation w/ low VT
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** Mechanical ventilation w/ low VT
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* Increased intra-abdominal pressure (e.g. insufflation)
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** Increased intra-abdominal pressure (e.g. insufflation)
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* Thorax Open
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** Thorax Open
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* Spontaneously breathing
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** Spontaneously breathing
 
* Cardiogenic pulmonary edema
 
* Cardiogenic pulmonary edema
 
* Tricuspid regurgitation
 
* Tricuspid regurgitation
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* 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]. [https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD016365/full source]
    
=SCD hemodynamic effects=
 
=SCD hemodynamic effects=
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Ovid MEDLINE(R) ALL <1946 to November 10, 2026>
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# (pneumatic sleeve or graduated compression stockings or mechanical thromboprophylaxis or sequential compression device).mp. or Intermittent Pneumatic Compression Devices/ (n=1479)
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# (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)
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# 1 and 2 (n=80)
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# 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)
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{| class="wikitable"
 
{| class="wikitable"
 
|+ Caption text
 
|+ Caption text
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|-
 
|-
 
| [https://pubmed.ncbi.nlm.nih.gov/18219162/ Sohn et al Circulation J 2008] || Example || Example || Example || Example
 
| [https://pubmed.ncbi.nlm.nih.gov/18219162/ Sohn et al Circulation J 2008] || Example || Example || Example || Example
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|-
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|Homdee et al Scientific Reports 2026<ref>https://scholar.googleusercontent.com/scholar.bib?q=info:sqwm0zNm_BAJ:scholar.google.com/&output=citation&scisdr=CoZuVH0GEIjgiyCl0SU:AIL1Nv4AAAAAavSjySUVsxxtbny2m28IhBo-8-o&scisig=AIL1Nv4AAAAAavSjyT2hZWiRRIQgt1kiFdRSsQ0&scisf=4&ct=citation&cd=-1&hl=en</ref>
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|12 healthy volunteers
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|Simultaneous 50 mmHg, 30 mmHg, or intermittent 30 mmHg via IPCDs
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|
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|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.
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|-
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|Yao et al, IJOA, 2026<ref>https://scholar.googleusercontent.com/scholar.bib?q=info:TO6u4e49AoQJ:scholar.google.com/&output=citation&scisdr=CoZuVH0GEIjgiyCgNw8:AIL1Nv4AAAAAavSmLw8KVm7zjfDZFuQQHEk270k&scisig=AIL1Nv4AAAAAavSmL-PMBf2BW5ICf0v3r0OoZwI&scisf=4&ct=citation&cd=-1&hl=en</ref>
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|26 healthy women undergoing elective CD with spinal anesthesia
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|Unblinded, RCT, IPC initiation at time of spinal
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|No IPCs
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|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).
 
|}
 
|}

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