Method to obtain and validate physiological data

A method for the acquisition and validation of physiological data for use thereof with a physiological monitor for simultaneously taking oxygen saturation values in a human patient's preductal and postductal blood flow, wherein said physiological monitor comprises:

• two LED light-emitting/receiving sensors connected to a corresponding pulse oximeter to be placed on two or more parts of the patient's body, wherein each pulse oximeter is connected to information processing means, wherein the method for the acquisition and validation of physiological data comprises:
• a) verifying that:
• sensors are connected to the medical device, that sensor receptor captures the light signal emitted by the sensor, and that the recorded physiological data is consistent with the heart rate readings;
• b) upon successful conclusion of step a), beginning the study and establishing the following variables:
• elapsed time of the study (Tt;
• starting at 0 seconds);
• maximum time of the study (Tmax=specific time constant);
• sampling time (Tm=specific time constant) during which the physiological data, needed for the statistical study, is collected;
• reading time (TL=specific time constant), said reading time being the interval at which physiological data is retrieved from the communication port;
• validation time (Tv), which defines the time at which statistical analysis is carried out, said validation time comprising one or more preset time values greater than Tm;
• c) retrieving physiological data (heart rate, oxygen saturation in preductal and postductal blood flow, as well as the values needed to generate a plethysmographic curve) separately and simultaneously from each of said two sensors and stored in the pulse oximeters by said information processing means within a preset reading time interval (TL);
• d) repeating step c) every TL until the following condition is met:
• Tt=Tv, and if this condition is met, proceeding to the next step;
• e) making a statistical validation of the heart rate values retrieved from said two sensors—where said information is stored in the pulse oximeters and retrieved by the information processing means—defined based on the volume and characteristics thereof, and comprising the following sub-steps:
• i. calculating the absolute differences for each record of heart rates comprised within the time interval under analysis;
• ii. obtaining two or more random samples of the maximum absolute differences previously calculated, wherein each sample includes 10% of the population of retrieved heart rate data (n);
• iii. calculating the following statistics for each heart rate data samples:
• (1) mean difference average (dm), (2) standard deviation (sd), and (3) t value (of the statistical test known as t-Student) for each sample (τ) taken in sub-step ii, in accordance with the following formulas:
• d
• m
• =
• ∑
• i
• =
• 1
• n
• ⁢
• d
• i
• n
• 
• (
• 1
• )
• s
• d
• =
• ∑
• i
• =
• 1
• n
• ⁢
• (
• d
• i
• -
• d
• m
• )
• 2
• n
• -
• 1
• (
• 2
• )
• τ
• =
• d
• m
• s
• d
• ⁢
• n
• (
• 3
• )
• iv. applying the following conditions:
• dm<‘preset value’ and sd<‘preset value’, wherein said preset values for the present particular embodiment of the invention are:
• dm<4.602 beats/minute and sd<4.718 beats/minute;
• v. if the established conditions are met in sub-step iv, comparing the τ value (calculated in sub-step III) to the t value in the t-Student test table;
• where, if τ>2.55, it is concluded that there is not a significant difference between the preductal and the postductal blood flow (99% certainty);
• that is, heart rates are statistically similar and, therefore, the analyzed heart rate data samples are considered as having approved the statistical validation;
• otherwise, the analyzed heart rate data samples are considered as having failed the statistical validation;
• f) if heart rate data, acquired in this manner, does not approve step e), and Tt<Tmax, repeating steps c), d) and e);
• g) if heart rate data, acquired in this manner, does not approve step e), and Tt>=Tmax, concluding the method;
• h) if heart rate data, acquired in this manner, does approve step e), said heart rate data may be considered as being suitable for use.