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→Study Design
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==
* NSR
* NSR
* Positive pressure ventilation
* Positive pressure ventilation
==Exclusion Criteria (LIMITS [https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-022-01022-8 mnemonic])==
==Exclusion Criteria==
* Low HR/RR ratio
* LIMITS [https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-022-01022-8 mnemonic]
* Irregular rhythm
** Low HR/RR ratio
* Mechanical ventilation w/ low VT
** Irregular rhythm
* Increased intra-abdominal pressure (e.g. insufflation)
** Mechanical ventilation w/ low VT
* Thorax Open
** Increased intra-abdominal pressure (e.g. insufflation)
* Spontaneously breathing
** Thorax Open
** Spontaneously breathing
* Cardiogenic pulmonary edema
* Cardiogenic pulmonary edema
* Tricuspid regurgitation
* Tricuspid regurgitation