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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. |
| | + | |
| | =Study Design= | | =Study Design= |
| | ==Inclusion Criteria== | | ==Inclusion Criteria== |
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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] |
| − | * Low HR/RR ratio | + | ** Low HR/RR ratio |
| − | * Irregular rhythm | + | ** Irregular rhythm |
| − | * Mechanical ventilation w/ low VT | + | ** Mechanical ventilation w/ low VT |
| − | * Increased intra-abdominal pressure (e.g. insufflation) | + | ** Increased intra-abdominal pressure (e.g. insufflation) |
| − | * Thorax Open | + | ** Thorax Open |
| − | * Spontaneously breathing | + | ** Spontaneously breathing |
| | * Cardiogenic pulmonary edema | | * Cardiogenic pulmonary edema |
| | * Tricuspid regurgitation | | * 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]. [https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD016365/full source] |
| | | | |
| | =SCD hemodynamic effects= | | =SCD hemodynamic effects= |
| | + | |
| | + | Ovid MEDLINE(R) ALL <1946 to November 10, 2026> |
| | + | |
| | + | # (pneumatic sleeve or graduated compression stockings or mechanical thromboprophylaxis or sequential compression device).mp. or Intermittent Pneumatic Compression Devices/ (n=1479) |
| | + | # (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) |
| | + | # 1 and 2 (n=80) |
| | + | # 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) |
| | + | |
| | {| 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 |
| | + | |- |
| | + | |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> |
| | + | |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<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> |
| | + | |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). |
| | |} | | |} |