Ultrasound assessment of the gastric content among diabetic and non-diabetic patients before elective surgery: a prospective multicenter study.

BACKGROUND: Although diabetic gastroparesis could be responsible for delayed gastric emptying, there is conflicting evidence about the volume of gastric content in diabetic patients after preoperative fasting. We hypothesized that diabetic patients had an increased gastric content before anesthesia induction despite the following of fasting recommendations. We used ultrasound assessment of gastric content to evaluate this risk. METHODS: This multicenter prospective single-blinded case-control study was conducted in three teaching University hospital in France. Our primary outcome was the comparison of increased gastric content between the two groups and was defined either by a Perlas grade 2 antrum or an antral cross-sectional area (CSA)>340 mm2. Each diabetic patient was paired with three non-diabetic control patients. Forty-two diabetic and 126 control patients were included in the study. RESULTS: Eighteen (42.9%) diabetic patients reached the primary outcome versus 28 (22.2%) in the control group (P=0.009). Diabetic patients presented less frequently with an empty stomach. Indeed, ten (23.8%) diabetic patients had a grade 0 antrum versus 71 (56.3%) in the control group (P<0.001). Twenty-four (70.6%) diabetic patients had an antral CSA<340 mm2 versus 98 (86%) in the control group (P=0.039). Overall, diabetic patients and increased gastric content were associated with an Odds Ratio, 2.63; 95% confidence interval, 1.25-5.52, P=0.009. CONCLUSIONS: Our study documents that gastric content is increased among diabetic patients compared to control patients despite following appropriate fasting guidelines.

Screening for postoperative vital signs abnormalities, and particularly hemodynamic ones, by continuous monitoring: protocol for the Biobeat-Postop cohort study.

Background: Postoperative hypotension associated with postoperative morbidity and early mortality has been studied previously. Hypertension and other hemodynamic, respiratory, and temperature abnormalities have comparatively understudied during the first postoperative days. Methods: This bi-centre observational cohort study will include 114 adult patients undergoing non-cardiac surgery hospitalized on an unmonitored general care floor and wearing a multi-signal wearable sensor, allowing remote monitoring ( Biobeat Technologies Ltd, Petah Tikva, Israel). The study will cover the first 72 hours after discharge of the patient from the post-anaesthesia care unit. Several thresholds will be used for each variable (arterial pressure, heart rate, respiratory rate, oxygen saturation, and skin temperature). Data obtained using the sensor will be compared to data obtained during the routine nurse follow-up. The primary outcome is hemodynamic abnormality. The secondary outcomes are postoperative respiratory and temperature abnormalities, artefacts and blank/null outputs from the wearable device, postoperative complications, and finally, the ease of use of the device. We hypothesize that remote monitoring will detect abnormalities in vital signs more often or more quickly than the detection by nurses' routine surveillance. Discussion: A demonstration of the ability of wireless sensors to outperform standard monitoring techniques paves the way for the creation of a loop which includes this monitoring mode, the automated creation of alerts, and the sending of these alerts to caregivers. Trial registration: ClinicalTrials.gov, NCT04585178. Registered on October 14, 2020.

Patch validation: an observational study protocol for the evaluation of a multisignal wearable sensor in patients during anaesthesia and in the postanaesthesia care unit.

INTRODUCTION: Except for operating rooms, postanaesthesia care units and intensive care units, where the monitoring of vital signs is continuous, intermittent care is standard practice. However, at a time when only the patients with the most serious conditions are hospitalised and only a fraction of these patients are in intensive care units, this type of monitoring is no longer sufficient. Wireless monitoring has been proposed, but it requires rigorous validation. The aim of this observational study is to compare vital signs obtained from a precordial patch sensor to those obtained with conventional monitoring. METHODS AND ANALYSIS: This patch validation trial will be an observational, prospective, single-centre open study of 115 anaesthetised adult patients monitored with both a wireless sensor (myAngel VitalSigns, Devinnova, Montpellier, France) and a standard bedside monitor (Carescape Monitor B850, GE Healthcare, Chicago, Illinois). Both sensors will be used to record peripheral oxygen saturation, respiratory rate, heart rate, body temperature and blood pressure (systolic and diastolic). The main objective will be to assess the degree of agreement between the two systems during the patients' stay in the postanaesthesia care unit, both at the raw signal level and at the clinical parameter level. The secondary objectives will be to assess the same performance under anaesthesia, the frequency of missing data or artefacts, the diagnostic performance of the systems, the influence of patients' characteristics on agreement between the two systems, the adverse events and the acceptability of the patch to patients. Bland-Altman plots will be used in the main analysis to detect discrepancies and estimate the limits of agreement. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethical Committee (Toulouse, France) on 10 April 2020. We are not yet recruiting subjects for this study. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04344093.

Automated measurement of tracheal and main bronchial diameters: a feasibility study.

BACKGROUND: A thoracic computed tomography scan is rarely used to help choose the appropriate double-lumen tube. Nowadays, bronchial measurements can be automated using dedicated software. The aim of this prospective monocentric study was to compare manual and automated measurements of the diameter of the trachea and both main bronchi in adult patients free from a history of lung surgery or disease. METHODS: Diameters of the trachea and of the main stem bronchi were measured by trained physicians or automatically using Thoracic Volume Computer Assisted Reading software (GE Healthcare, Chicago, IL, USA). Manual measurements were considered as the goal standard. RESULTS: Two hundred and forty-three patients were assessed for eligibility, 216 were allocated to intervention and 173 analyzed: 102 males and 71 females (61.4±13.9 years, 169.7±9.4 cm, 73.3±16.8 kg). Reliability between the two investigators was poor (20.8±9.0% of measurements with a difference >10%). Intraclass correlation coefficient (ICC) and its confidence interval at 95% (ICC [95% CI]) was 0.97 [0.96; 0.98] for the maximal diameter and 0.94 [0.92; 0.95] for the minimal diameter of the trachea (P<0.01 for both). ICC [95% CI] was 0.97 [0.94; 0.98] for the maximal diameter and 0.93 [0.90; 0.95] for the minimal diameter of the right main bronchus (P<0.01 for both). ICC [95% CI] was 0.96 [0.95; 0.97] for the maximal diameter and 0.93 [0.90; 0.95] for the minimal diameter of the left main bronchus (P<0.01 for both). CONCLUSIONS: This feasibility study has mixed results since automated measurements were not feasible in around 20% of the cases.