Dataset Information

Evaluation of Predictive Values of an Automatic Device Measuring Oximetry in Free Flaps.

ABSTRACT: Free-flap monitoring is challenging to perform in some centers. It requires the availability of trained health care personnel for 24 hours a day and seven days a week. Many methods had been proposed for flap monitoring, and none of them are superior to clinical evaluation. This study aimed to present a murine model to evaluate the accuracy (sensitivity, specificity, and the positive or negative predictive values) of a device. Wistar rats weighing 240-490 g were included for intervention and data collection. A murine model of left inferior epigastric vessel flaps was implemented. Intermittent pedicle clamping was performed to calculate the accuracy of the device that detects flow obstruction. The general variables studied were age, weight, and gender. The sensitivity, specificity, and negative or predictive values were calculated. The results showed a sensitivity of 97%, a specificity of 95% with a positive predictive value of 95%, and negative predictive value of 97%. The sensitivity and specificity showed excellent results within the range of clinical security. We require more data to analyze the multiparameter monitoring to see if it is feasible and cost-effective.

SUBMITTER: Rendon-Medina MA

PROVIDER: S-EPMC8460219 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Evaluation of Predictive Values of an Automatic Device Measuring Oximetry in Free Flaps.

Rendón-Medina Marco Aurelio MA Galeana-Pavón Alberto A Vázquez-Medina Martín Uriel MU Hernández-Ordoñez Rubén R Ocharan-Hernández María Esther ME Hanson-Viana Erik E Sashida-Mendez Hirosi H Mendoza-Vélez María de Los Ángeles MLÁ Pacheco-López Ricardo César RC

Plastic and reconstructive surgery. Global open 20210922 9

Free-flap monitoring is challenging to perform in some centers. It requires the availability of trained health care personnel for 24 hours a day and seven days a week. Many methods had been proposed for flap monitoring, and none of them are superior to clinical evaluation. This study aimed to present a murine model to evaluate the accuracy (sensitivity, specificity, and the positive or negative predictive values) of a device. Wistar rats weighing 240-490 g were included for intervention and data ...[more]

PMID: 34584825

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Project description:Background: The US Food and Drug Administration (FDA) and International Organization for Standardization (ISO) clearance standards for the clinical use of smart device pulse oximetry require in-laboratory human hypoxemia testing in healthy human individuals using arterial blood gas analysis. Methods: We evaluated the SpO2 measurements of the Samsung smartphone (Galaxy S9/10) and smartwatch (Galaxy 4) at stable arterial oxygen saturations (SaO2) between 70 and 100% in 24 healthy participants. Testing followed FDA/ISO-stipulated procedures for pulse oximetry performance validation, which include questionnaire estimation of skin tone based on Fitzpatrick estimation of skin types I-VI. During testing, inspired oxygen, nitrogen, and carbon dioxide partial pressures were monitored and adjusted via partial rebreathing circuits to achieve stable target arterial blood oxygen (SaO2) plateaus between 70% and 100%. Arterial blood samples were taken at each plateau, with device SpO2 readings taken at each sample extraction. An ABL-90FLEX blood gas analyzer determined arterial blood sample SaO2. Bias, calculated from device readings minus corresponding arterial blood measurements, was reported as root mean square deviation (RMSD). Results: Combined Participants demographics were: 62.5% female; median age 26 years (range 21-46); and race/ethnicity 16.7% African American, 33.3% Asian, 12.5% multi-ethnic, and 37.5% Caucasian. Fitzpatrick Skin Scale-identified skin tones were: white-fair (I&II), 20.8%; average-light brown (III-IV), 54% and brown-black (V-VI), 25%. There were no adverse events. The RMSD values of SpO2 measurements were: smartphone 2.6% (257 data pairs) and smartwatch 1.8% (247 data pairs). Conclusions: Device SpO2 demonstrated RMSD < 3.0% to SaO2, meeting FDA/ISO clearance standards at the time of study. However, additional testing in persons with darker skin tones is necessary. Smartphones and paired wearables, when cleared for clinical use following revision of FDA clearance standards, may expand access to remote pulse oximetry.

Project description:BackgroundFree flap design must fulfill different criteria to ensure functional and aesthetic reconstruction of different types of defects in different body areas. A four-dimensional planning concept was used including flap length, width, thickness and tissue composition. This study evaluates if body-mass-index (BMI) has a predictive value for flap design.MethodsA prospective study including hospitalized patients in the Department of Plastic, Aesthetic, Hand and Reconstructive Surgery was conducted. Not taking into account the reason for admission, the patients were examined based on age, weight, height, BMI and sex. The areas of a potential harvest of free fasciocutaneous and perforator flaps were measured using ultrasound examination to determine the thickness of the subcutaneous layers and prove blood perfusion.ResultsOver the period of four months, a total of 101 patients (36 females and 65 males) were included in this study and gave written consent. No statistical significance regarding the demographic data such as age, sex and BMI could be identified. An average to high correlation between free flap thickness and BMI was shown for the thoracodorsal artery perforator (TDAP), anterior lateral thigh (ALT) and deep inferior epigastric perforator (DIEP) flap in both, male and female patients. Free flaps of distal body parts such as the interosseous posterior flap, showed a lower correlation. No correlation using the Pearson coefficient could be found for age and volume.ConclusionOur study demonstrated that the BMI is a predictive indicator that can be used in the preoperative planning of reconstructions using free flaps. Depending on the defect location, the BMI can be considered to predict the thickness of the free flap and may influence the surgeon's choice. On the other hand, a lower correlation between BMI and flap thickness encourages the use of standard flaps if more volume is desired, as the DIEP flap might be sufficient even in normal-weight women. Flaps of distal body parts, such as the forearm or lower leg, are not prone to such predictions and require other selection criteria.

Dataset Information

Evaluation of Predictive Values of an Automatic Device Measuring Oximetry in Free Flaps.

Publications

Evaluation of Predictive Values of an Automatic Device Measuring Oximetry in Free Flaps.

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