Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea.

PURPOSE: The cardiorespiratory polysomnography (PSG) is an expensive and limited resource. The Sleepiz One + is a novel radar-based contactless monitoring device that can be used e.g. for longitudinal detection of nocturnal respiratory events. The present study aimed to compare the performance of the Sleepiz One + device to the PSG regarding the accuracy of apnea-hypopnea index (AHI). METHODS: From January to December 2021, a total of 141 adult volunteers who were either suspected of having sleep apnea or who were healthy sleepers took part in a sleep study. This examination served to validate the Sleepiz One + device in the presence and absence of additional SpO2 information. The AHI determined by the Sleepiz One + monitor was estimated automatically and compared with the AHI derived from manual PSG scoring. RESULTS: The correlation between the Sleepiz-AHI and the PSG-AHI with and without additional SpO2 measurement was rp = 0.94 and rp = 0,87, respectively. In general, the Bland-Altman plots showed good agreement between the two methods of AHI measurement, though their deviations became larger with increasing sleep-disordered breathing. Sensitivity and specificity for recordings without additional SpO2 was 85% and 88%, respectively. Adding a SpO2 sensor increased the sensitivity to 88% and the specificity to 98%. CONCLUSION: The Sleepiz One + device is a valid diagnostic tool for patients with moderate to severe OSA. It can also be easily used in the home environment and is therefore beneficial for e.g. immobile and infectious patients. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION FOR PROSPECTIVELY REGISTERED TRIALS: This study was registered on clinicaltrials.gov (NCT04670848) on 2020-12-09.

Clinical validation of a contactless respiration rate monitor.

Respiratory rate (RR) is an often underestimated and underreported vital sign with tremendous clinical value. As a predictor of cardiopulmonary arrest, chronic obstructive pulmonary disease (COPD) exacerbation or indicator of health state for example in COVID-19 patients, respiratory rate could be especially valuable in remote long-term patient monitoring, which is challenging to implement. Contactless devices for home use aim to overcome these challenges. In this study, the contactless Sleepiz One+ respiration monitor for home use during sleep was validated against the thoracic effort belt. The agreement of instantaneous breathing rate and breathing rate statistics between the Sleepiz One+ device and the thoracic effort belt was initially evaluated during a 20-min sleep window under controlled conditions (no body movement) on a cohort of 19 participants and secondly in a more natural setting (uncontrolled for body movement) during a whole night on a cohort of 139 participants. Excellent agreement was shown for instantaneous breathing rate to be within 3 breaths per minute (Brpm) compared to thoracic effort band with an accuracy of 100% and mean absolute error (MAE) of 0.39 Brpm for the setting controlled for movement, and an accuracy of 99.5% with a MAE of 0.48 Brpm for the whole night measurement, respectively. Excellent agreement was also achieved for the respiratory rate statistics over the whole night with absolute errors of 0.43, 0.39 and 0.67 Brpm for the 10th, 50th and 90th percentiles, respectively. Based on these results we conclude that the Sleepiz One+ can estimate instantaneous respiratory rate and its summary statistics at high accuracy in a clinical setting. Further studies are required to evaluate the performance in the home environment, however, it is expected that the performance is at similar level, as the measurement conditions for the Sleepiz One+ device are better at home than in a clinical setting.

Calabadion: A new agent to reverse the effects of benzylisoquinoline and steroidal neuromuscular-blocking agents.

INTRODUCTION: To evaluate whether calabadion 1, an acyclic member of the Cucurbit[n]uril family of molecular containers, reverses benzylisoquinoline and steroidal neuromuscular-blocking agent effects. METHODS: A total of 60 rats were anesthetized, tracheotomized, and instrumented with IV and arterial catheters. Rocuronium (3.5 mg/kg) or cisatracurium (0.6 mg/kg) was administered and neuromuscular transmission quantified by acceleromyography. Calabadion 1 at 30, 60, and 90 mg/kg (for rocuronium) or 90, 120, and 150 mg/kg (for cisatracurium), or neostigmine/glycopyrrolate at 0.06/0.012 mg/kg were administered at maximum twitch depression, and renal calabadion 1 elimination was determined by using a H NMR assay. The authors also measured heart rate, arterial blood gas parameters, and arterial blood pressure. RESULTS: After the administration of rocuronium, resumption of spontaneous breathing and recovery of train-of-four ratio to 0.9 were accelerated from 12.3 ± 1.1 and 16.2 ± 3.3 min with placebo to 4.6 ± 1.8 min with neostigmine/glycopyrrolate to 15 ± 8 and 84 ± 33 s with calabadion 1 (90 mg/kg), respectively. After the administration of cisatracurium, recovery of breathing and train-of-four ratio of 0.9 were accelerated from 8.7 ± 2.8 and 9.9 ± 1.7 min with placebo to 2.8 ± 0.8 and 7.6 ± 2.1 min with neostigmine/glycopyrrolate to 47 ± 13 and 87 ± 16 s with calabadion 1 (150 mg/kg), respectively. Calabadion 1 did not affect heart rate, mean arterial blood pressure, pH, carbon dioxide pressure, and oxygen tension. More than 90% of the IV administered calabadion 1 appeared in the urine within 1 h. CONCLUSION: Calabadion 1 is a new drug for rapid and complete reversal of the effects of steroidal and benzylisoquinoline neuromuscular-blocking agents.

Development and validation of a score for prediction of postoperative respiratory complications.

BACKGROUND: Postoperative respiratory failure is associated with increased morbidity and mortality, as well as high costs of hospital care. METHODS: Using electronic anesthesia records, billing data, and chart review, the authors developed and validated a score predicting reintubation in the hospital after primary extubation in the operating room, leading to unplanned mechanical ventilation within the first 3 postoperative days. Using multivariable logistic regression analysis, independent predictors were determined and a score postulated and validated. RESULTS: In the entire cohort (n = 33,769 surgical cases within 29,924 patients), reintubation occurred in 137 cases (0.41%). Of those, 16%, (n = 22) died subsequently, whereas the mortality in patients who were not reintubated was 0.26% (P < 0.0001). Independent predictors for reintubation were: American Society of Anesthesiologist Score 3 or more, emergency surgery, high-risk surgical service, history of congestive heart failure, and chronic pulmonary disease. A point value of 3, 3, 2, 2, and 1 were assigned to these predictors, respectively, based on their ß coefficient in the predictive model. The score yielded a calculated area under the curve of 0.81, whereas each point increment was associated with a 1.7-fold (odds ratio: 1.72 [95% CI, 1.55-1.91]) increase in the odds for reintubation in the training dataset. Using the validation dataset (n = 16,884), the score had an area under the curve of 0.80 and similar estimated probabilities for reintubation. CONCLUSION: The authors developed and validated a score for the prediction of postoperative respiratory complications, a simple, 11-point score that can be used preoperatively by anesthesiologists to predict severe postoperative respiratory complications.

Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study.

OBJECTIVE: To determine whether use of intermediate acting neuromuscular blocking agents during general anesthesia increases the incidence of postoperative respiratory complications. DESIGN: Prospective, propensity score matched cohort study. SETTING: General teaching hospital in Boston, Massachusetts, United States, 2006-10. PARTICIPANTS: 18,579 surgical patients who received intermediate acting neuromuscular blocking agents during surgery were matched by propensity score to 18,579 reference patients who did not receive such agents. MAIN OUTCOME MEASURES: The main outcome measures were oxygen desaturation after extubation (hemoglobin oxygen saturation <90% with a decrease in oxygen saturation after extubation of >3%) and reintubations requiring unplanned admission to an intensive care unit within seven days of surgery. We also evaluated effects on these outcome variables of qualitative monitoring of neuromuscular transmission (train-of-four ratio) and reversal of neuromuscular blockade with neostigmine to prevent residual postoperative neuromuscular blockade. RESULTS: The use of intermediate acting neuromuscular blocking agents was associated with an increased risk of postoperative desaturation less than 90% after extubation (odds ratio 1.36, 95% confidence interval 1.23 to 1.51) and reintubation requiring unplanned admission to an intensive care unit (1.40, 1.09 to 1.80). Qualitative monitoring of neuromuscular transmission did not decrease this risk and neostigmine reversal increased the risk of postoperative desaturation less than 90% (1.32, 1.20 to 1.46) and reintubation (1.76, 1.38 to 2.26). CONCLUSION: The use of intermediate acting neuromuscular blocking agents during anesthesia was associated with an increased risk of clinically meaningful respiratory complications. Our data suggest that the strategies used in our trial to prevent residual postoperative neuromuscular blockade should be revisited.

Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit.

BACKGROUND: Paresis acquired in the intensive care unit (ICU) is common in patients who are critically ill and independently predicts mortality and morbidity. Manual muscle testing (MMT) and handgrip dynamometry assessments have been used to evaluate muscle weakness in patients in a medical ICU, but similar data for patients in a surgical ICU (SICU) are limited. OBJECTIVE: The purpose of this study was to evaluate the predictive value of strength measured by MMT and handgrip dynamometry at ICU admission for in-hospital mortality, SICU length of stay (LOS), hospital LOS, and duration of mechanical ventilation. DESIGN: This investigation was a prospective, observational study. METHODS: One hundred ten patients were screened for eligibility for testing in the SICU of a large, academic medical center. The Acute Physiology and Chronic Health Evaluation (APACHE) II score, diagnoses, and laboratory data were collected. Measurements were obtained by MMT quantified with the sum (total) score on the Medical Research Council Scale and by handgrip dynamometry. Outcome data, including in-hospital mortality, SICU LOS, hospital LOS, and duration of mechanical ventilation, were collected for all participants. RESULTS: One hundred seven participants were eligible for testing; 89% were tested successfully at a median of 3 days (25th-75th percentiles=3-6 days) after admission. Sedation was the most frequent barrier to testing (70.6%). Manual muscle testing was identified as an independent predictor of mortality, SICU LOS, hospital LOS, and duration of mechanical ventilation. Grip strength was not independently associated with these outcomes. LIMITATIONS: This study did not address whether muscle weakness translates to functional outcome impairment. CONCLUSIONS: In contrast to handgrip strength, MMT reliably predicted in-hospital mortality, duration of mechanical ventilation, SICU LOS, and hospital LOS.

The surgical intensive care unit optimal mobility score predicts mortality and length of stay.

OBJECTIVES: To test if the surgical intensive care unit optimal mobility score predicts mortality and intensive care unit and hospital length of stay. DESIGN: Prospective single-center cohort study. SETTING: Surgical intensive care unit of the Massachusetts General Hospital. PATIENTS: One hundred thirteen consecutive patients admitted to the surgical intensive care unit. INVESTIGATIONS: We tested the hypotheses that the surgical intensive care unit optimal mobility score independent of comorbidity index, Acute Physiology and Chronic Health Evaluation II, creatinine, hypotension, hypernatremia, acidosis, hypoxia, and hypercarbia predicts hospital mortality, surgical intensive care unit and total hospital length of stay. MEASUREMENTS AND MAIN RESULTS: Two nurses independently predicted the patients' mobilization capacity by using the surgical intensive care unit optimal mobility score the morning after admission, whereas a third nurse recorded the achieved mobilization levels of patients at the end of the day. A multidisciplinary expert team measured patients' grip strength and assessed their predicted mobilization capacity independently. Multivariate analysis revealed that the surgical intensive care unit optimal mobility score was the only independent predictor of mortality. Surgical intensive care unit optimal mobility score, hypotension, and hypernatremia (>144 mmol/L) independently predicted intensive care unit length of stay, whereas the surgical intensive care unit optimal mobility score and hypernatremia predicted total hospital length of stay. The Acute Physiology and Chronic Health Evaluation II score was not identified in the multivariate analysis. The surgical intensive care unit optimal mobility score was also a reliable and valid instrument in predicting achieved mobilization levels of patients. CONCLUSIONS: In surgical critically ill patients presenting without preexisting impairment of functional mobility, the surgical intensive care unit optimal mobility score is a reliable and valid tool to predict mortality and intensive care unit and hospital length of stay.

Ketamine activates breathing and abolishes the coupling between loss of consciousness and upper airway dilator muscle dysfunction.

BACKGROUND: Procedural sedation is frequently performed in spontaneously breathing patients, but hypnotics and opioids decrease respiratory drive and place the upper airway at risk for collapse. METHODS: In a randomized, controlled, cross-over, pharmaco-physiologic study in 12 rats, we conducted acute experiments to compare breathing and genioglossus electromyogram activity at equianesthetic concentrations of ketamine, a noncompetitive N-methyl-D-aspartate receptor antagonist that combines potent analgesic with hypnotic action effects, versus propofol. In 10 chronically instrumented rats resting in a plethysmograph, we measured these variables as well as electroencephalography during five conditions: quiet wakefulness, nonrapid-eye-movement sleep, rapid eye movement sleep, and low-dose (60 mg/kg intraperitoneally) and high-dose ketamine anesthesia (125 mg/kg intraperitoneally). RESULTS: Ketamine anesthesia was associated with markedly increased genioglossus activity (1.5 to fivefold higher values of genioglossus electromyogram) compared with sleep- and propofol-induced unconsciousness. Plethysmography revealed a respiratory stimulating effect: higher values of flow rate, respiratory rate, and duty-cycle (effective inspiratory time, 1.5-to-2-fold higher values). During wakefulness and normal sleep, the δ (f = 6.51, P = 0.04) electroencephalogram power spectrum was an independent predictor of genioglossus activity, indicating an association between electroencephalographic determinants of consciousness and genioglossus activity. Following ketamine administration, electroencephalogram power spectrum and genioglossus electroencephalogram was dissociated (P = 0.9 for the relationship between δ/θ power spectrum and genioglossus electromyogram). CONCLUSIONS: Ketamine is a respiratory stimulant that abolishes the coupling between loss-of-consciousness and upper airway dilator muscle dysfunction in a wide dose-range. Ketamine compared with propofol might help stabilize airway patency during sedation and anesthesia.

The ventrolateral preoptic nucleus is not required for isoflurane general anesthesia.

Neurons of the ventrolateral preoptic nucleus (VLPO) promote sleep and VLPO loss produces insomnia. Previous studies show that general anesthetics including isoflurane activate VLPO neurons, and may contribute to their sedative effects. However, it is not clear to what extent the activation of VLPO neurons contributes to general anesthesia. We tested whether destruction of the VLPO neurons would affect the onset, depth, or recovery from isoflurane's general anesthetic effects. The VLPO was ablated in 25 rats by bilateral local injection of orexin-saporin, and polysomnography was performed to measure baseline sleep loss and responses to isoflurane anesthesia at 1% and 2%. Eight rats received sham (saline) injections. We measured isoflurane effects on time to loss of righting reflex, onset of continuous slow wave activity, and burst suppression; burst-suppression ratio; and time to recovery of righting reflex and desynchronized EEG. VLPO neuron cell loss was quantified by post hoc histology. Loss of VLPO neurons as well as lesion size were associated with cumulative sleep loss (r=0.77 and r=0.62, respectively), and cumulative sleep loss was the strongest predictor of high sensitivity to anesthesia, expressed as decreased time to loss of righting reflex (-0.59), increased burst-suppression ratio (r=0.52) , and increased emergence time (r=0.54); an interaction-effect of isoflurane dose was observed (burst-suppression ratio: p<0.001). We conclude that the sleep loss caused by ablation of VLPO neurons sensitizes animals to the general anesthetic effects of isoflurane, but that the sedation produced by VLPO neurons themselves is not required for isoflurane anesthesia.

Do Patients with Obstructive Sleep Apnea have an Increased Risk of Desaturation During Induction of Anesthesia for Weight Loss Surgery?

BACKGROUND: Obstructive sleep apnea (OSA) is an independent risk factor to develop perioperative complications during weight loss surgery, but the mechanisms are unclear. It is possible, that patients with OSA have a higher incidence of desaturation during induction of anesthesia. METHODS: We enrolled 100 morbidly obese (body mass index: 53+/-10) adult patients undergoing open bariatric surgery in a prospective study. At least 1 h before induction of anesthesia, peripheral oxygen saturation (SpO(2)) was measured by an oximetry finger probe in the sitting and supine positions, and Mallampati score was taken. Oxygen saturation was recorded also during induction of anesthesia, and nadir values were analyzed, and the STOP-BANG questionnaire was applied. RESULTS: Thirty-six patients presented with clinical suspicion of OSA. Body weight predicted oxygen saturation in the supine and sitting position, prior to induction of anesthesia. Nadir oxygen saturation during induction of anesthesia was considerably higher in patients with clinical suspicion of OSA, a significant finding that persisted as a trend after correction for age, gender and BMI. The Mallampati score was an independent predictor of OSA, even in morbidly obese patients scheduled for weight loss surgery. CONCLUSIONS: Morbidly obese patients presenting for weight loss surgery have a significant risk to desaturate during induction of anesthesia. A history of OSA does not independently increase the risk of desaturation during induction of anesthesia, if the appropriate precautions are being taken.