Clinical implementation of automated O2 titration in a tertiary care hospital.

Background: When treating acute respiratory failure, both hypoxemia and hyperoxemia should be avoided. SpO2 should be monitored closely and O2 flows adjusted accordingly. Achieving this goal might be easier with automated O2 titration compared to manual titration of fixed-flow O2 We evaluated the feasibility of using an automated O2 titration device in subjects treated for acute hypoxemic respiratory failure in a tertiary care hospital.Methods: Healthcare workers received education and training about oxygen therapy and were familiarized with an automated O2 titration device (FreeO2, Oxynov, Quebec City, Canada). A coordinator was available from 8 am to 5 pm during week days to provide technical assistance. The ability of the device to maintain SpO2 within the prescribed therapeutic window was recorded. Basic clinical information was recorded.Results: Subjects were enrolled from November 2020 to August 2022. We trained 508 healthcare workers on use of automated O2 titration which was finally used on 872 occasions in 763 subjects, distributed on the respiratory, COVID-19 and thoracic surgery wards and the emergency room. Clinical information could be retrieved for 609 (80%) subjects who were on the system for a median of 3 days (interquartile range: 2 to 6 days) representing 2567 subject-days of clinical experience with the device. In the 82 (14%) subjects for whom this information was available, the system maintained SpO2 within the prescribed targets 89% of the time. Ninety-six subjects experienced clinical deterioration as defined by the need to be transferred to the intensive care unit and/or requirement of high nasal flow oxygen but none of these events were judged to be related to the O2 device.Conclusions: Automated O2 titration could be successfully implemented in hospitalized subjects with hypoxemic respiratory failure from various causes. This experience should foster further improvement of the device and recommendations for an optimized utilization.

Evaluation of the Humidification Performances of New Generation of Heated Wire Humidifiers.

BACKGROUND: At high ambient temperatures in ICU rooms, the humidification performances of heated-wire humidifiers are significantly reduced, with delivered gas humidity well below 30 mg H2O/L, which leads to an increased risk of endotracheal occlusions, subocclusions, or mucociliary dysfunction. The objective of the study was to evaluate the humidity delivered at the Y-piece with new-generation heated-wire humidifiers with advanced algorithm (FP950 [Fisher & Paykel Healthcare, Auckland, New Zealand] and VHB20 [Vincent Medical, Inspired, Hong Kong]) while varying ambient temperatures. METHODS: We measured, on the bench, the hygrometry of inspiratory gases delivered by a new generation of heated-wire humidifiers (i) FP950, (ii) VHB20 and a previous generation of heated-wire humidifiers, (iii) MR850 (Fisher & Paykel) with the usual settings (37°C at the chamber/40°C at the Y-piece), (iv) MR850 with no temperature gradient (40°C/40°C), and (v) MR850 with the automatic compensation algorithm activated. Hygrometry was measured with the psychrometric method after 1 h of stability while varying the room temperature from 20 to 30°C. RESULTS: Two hundred ninety-four hygrometric bench measurements were performed at steady state for the different tested conditions. With the new heated-wire humidifiers (FP950 and VHB20), gas humidity delivered remained > 30 mg H2O/L in all tested conditions, even at high ambient temperatures (>25°C). With previous generations of heated-wire humidifiers (MR850), at high ambient temperature, humidity delivered was adequate in only 26% (11/42) of the measurements when the usual settings were used (37°C/40°C) and 30% (11/37) with automatic compensation. When no temperature gradient was set (40°C/40°C), humidity delivered was > 30 mg H2O/L in 91% (30/33) of the measurements at a high ambient temperature. With an ambient temperature < 25°C, almost all devices and settings provided adequate humidity. CONCLUSIONS: The new FP950 and VHB20 heated-wire humidifiers by using advanced algorithms demonstrated stable performance while varying the ambient temperature by 20-30°C, better than the previous generation of heated humidifiers when ambient temperatures were high.

Automated O2 Titration Alone or With High-Flow Nasal Cannula During Walking Exercise in Chronic Lung Diseases.

BACKGROUND: Exercise-induced O2 desaturation contributes to dyspnea and exercise intolerance in various respiratory diseases. This study assessed whether automated O2 titration was superior to fixed-flow O2 to improve exertional dyspnea and walking exercise endurance. We also aimed at evaluating possible additive effects of high-flow nasal cannula coupled with automated O2 titration on these outcomes. METHODS: Subjects with chronic respiratory diseases and exercise-induced desaturation performed a 3-min constant-speed shuttle test (CSST) and an endurance shuttle walking test (ESWT) with either (1) fixed-flow O2, (2) automated O2 titration targeting an SpO2 of 94% (± 2%), and (3) automated O2 titration + high-flow nasal cannula according to a randomized sequence. The main outcome was Borg dyspnea score at the end of the 3-min CSST. Secondary outcomes included endurance time and dyspnea during ESWT and oxygenation status during exercise. RESULTS: Ten subjects with COPD, 10 with interstitial lung disease, 5 with pulmonary hypertension, and 3 with cystic fibrosis completed the study. Compared to fixed-flow O2, automated O2 titration did not reduce dyspnea at the end of the 3-min CSST. Endurance time during the ESWT was prolonged with automated O2 titration (mean difference 298 [95% CI 205-391] s, P < .001), and dyspnea at isotime was reduced. No further improvement was noted when high-flow nasal cannula was added to automated O2 titration. Compared to fixed-flow O2, O2 flows were higher with automated O2 titration, resulting in better oxygenation. CONCLUSIONS: Automated O2 titration was superior to fixed-flow O2 to alleviate dyspnea and improve exercise endurance during the ESWT in subjects with a variety of chronic respiratory diseases. Adding high-flow nasal cannula to automated O2 titration provided no further benefits.

Automated Oxygen Titration During CPAP and Noninvasive Ventilation in Healthy Subjects With Induced Hypoxemia.

BACKGROUND: Automated oxygen titration to maintain a stable SpO2 has been developed for spontaneously breathing patients but has not been evaluated during CPAP and noninvasive ventilation (NIV). METHODS: We performed a randomized controlled crossover, double-blind study on 10 healthy subjects with induced hypoxemia during 3 situations: spontaneous breathing with oxygen support, CPAP (5 cm H2O), and NIV (7/3 cm H2O). We conducted in random order 3 dynamic hypoxic challenges of 5 min (FIO2 0.08 ± 0.02, 0.11± 0.02, and 0.14 ± 0.02). For each condition, we compared automated oxygen titration and manual oxygen titration by experienced respiratory therapists (RTs), with the aim to maintain the SpO2 at 94 ± 2%. In addition, we included 2 subjects hospitalized for exacerbation of COPD under NIV and a subject managed after bariatric surgery with CPAP and automated oxygen titration. RESULTS: The percentage of time in the SpO2 target was higher with automated compared with manual oxygen titration for all conditions, on average 59.6 ± 22.8% compared to 44.3 ± 23.9% (P = .004). Hyperoxemia (SpO2 > 96%) was less frequent with automated titration for each mode of oxygen administration (24.0 ± 24.4% vs 39.1 ± 25.3%, P < .001). During the manual titration periods, the RT made several changes to oxygen flow (5.1 ± 3.3 interventions that lasted 122 ± 70 s/period) compared to none during the automated titration to maintain oxygenation in the targeted SpO2 . Time in the SpO2 target was higher with stable hospitalized subjects in comparison with healthy subjects under dynamic-induced hypoxemia. CONCLUSIONS: In this proof-of-concept study, automated oxygen titration was used during CPAP and NIV. The performances to maintain the SpO2 target were significantly better compared to manual oxygen titration in the setting of this study protocol. This technology may allow decreasing the number of manual interventions for oxygen titration during CPAP and NIV.

Accuracy of Multiple Pulse Oximeters in Stable Critically Ill Patients.

BACKGROUND: An accurate SpO2 value is critical in order to optimally titrate oxygen delivery to patients and to follow oxygenation guidelines. Limited prospective data exist on real-world performance of pulse oximeters in critically ill patients. The objective of this study was to assess accuracy and bias of the SpO2 values measured by several oximeters in hospitalized subjects. METHODS: We included stable adults in the ICU with an arterial catheter in place. Main exclusion criteria were poor SpO2 signal and SpO2 > 96%. In each subject, we simultaneously evaluated 4 oximeters: Nonin (Plymouth, Minnesota) embedded in the FreeO2 device (OxyNov, Québec City, Québec, Canada), Masimo (Radical-7, Masimo, Irvine, California), Philips (FAST, Philips, Amsterdam, the Netherlands), and Nellcor (N-600, Medtronic, Minneapolis, Minnesota). Arterial blood gases were drawn and simultaneously each oximeters' SpO2 values were collected. SpO2 values were compared to the reference (arterial oxygen saturation [SaO2 ] value) to determine bias and accuracy. The ability for oximeters to detect hypoxemia and the impact of oximeters on oxygen titration were evaluated. RESULTS: We included 193 subjects (153 male, mean age 66 y) in whom 211 sets of measurements were performed. The skin pigmentation evaluated by Fitzpatrick scale showed 96.2% of subjects were light skin (types 1 and 2). One oximeter overestimated SaO2 (Philips, +0.9%), whereas the 3 others underestimated SaO2 (Nonin -3.1%, Nellcor -0.3%, Masimo -0.2%). SaO2 was underestimated with Nonin oximeter in 91.3% of the cases, whereas it was overestimated in 55.2% of the cases with Philips oximeter. Moderate hypoxemia (SaO2 86-90% or PaO2 55-60 mm Hg) was detected in 92, 33, 42, and 11% of the cases with Nonin, Nellcor, Masimo, and Philips, respectively. CONCLUSIONS: We found significant bias and moderate accuracy between the tested oximeters and the arterial blood gases in the studied population. These discrepancies may have important clinical impact on the detection of hypoxemia and management of oxygen therapy.

Monitoring of Heated Wire Humidifier Hygrometric Performances With Heater Plate Temperature.

BACKGROUND: Under-humidification and associated complications may occur with heated humidifiers. Hygrometric performances of heated wire humidifiers are reduced by high ambient and high outlet ventilator temperatures. Currently, there is no reliable monitoring tool to evaluate humidification performances of heated wire humidifiers in the daily practice. We sought to demonstrate the relation between humidity delivered by heated wire humidifiers and different parameters that could be used to monitor humidity of gas delivered to subjects. METHODS: On a bench test, we measured heater plate temperature, inlet chamber temperature, and delivered humidity with MR850 system. Temperature displayed on the humidifier was also recorded. The measurements were performed at different ambient temperatures and five minute ventilation levels (5, 7.5, 10, 12.5, 15 L/min). Inlet chamber temperatures varied from 20-40°C. In each condition, hygrometric measurements with the psychrometric method were performed at steady state. RESULTS: We performed 279 measurements at steady state including all conditions. We found a good correlation between heater plate temperature and absolute humidity delivered (R2 = 0.82). This relationship was hardly affected by ambient temperature, but minute ventilation had more effect. For different minute ventilations, the correlation between heater plate temperature and absolute humidity delivered was very good with coefficient of determination R2 from 0.87-0.98. Heater plate temperature > 62°C was a good predictor of absolute humidity delivered > 30 mg H2O/L (area under the curve = 0.96, sensibility 79%, specificity 94%). No correlation existed between humidity delivered and the outlet chamber temperature (displayed on the humidifier). CONCLUSIONS: In this bench study, we have shown a good correlation between heater plate temperature and humidity delivered with a heated wire humidifier. This means that a "hidden" hygrometer is built into the heated wire humidifier. Heater plate temperature should be used as a surrogate of humidity to improve the humidification monitoring.

The PROMIZING trial enrollment algorithm for early identification of patients ready for unassisted breathing.

BACKGROUND: Liberating patients from mechanical ventilation (MV) requires a systematic approach. In the context of a clinical trial, we developed a simple algorithm to identify patients who tolerate assisted ventilation but still require ongoing MV to be randomized. We report on the use of this algorithm to screen potential trial participants for enrollment and subsequent randomization in the Proportional Assist Ventilation for Minimizing the Duration of MV (PROMIZING) study. METHODS: The algorithm included five steps: enrollment criteria, pressure support ventilation (PSV) tolerance trial, weaning criteria, continuous positive airway pressure (CPAP) tolerance trial (0 cmH2O during 2 min) and spontaneous breathing trial (SBT): on fraction of inspired oxygen (FiO2) 40% for 30-120 min. Patients who failed the weaning criteria, CPAP Zero trial, or SBT were randomized. We describe the characteristics of patients who were initially enrolled, but passed all steps in the algorithm and consequently were not randomized. RESULTS: Among the 374 enrolled patients, 93 (25%) patients passed all five steps. At time of enrollment, most patients were on PSV (87%) with a mean (± standard deviation) FiO2 of 34 (± 6) %, PSV of 8.7 (± 2.9) cmH2O, and positive end-expiratory pressure of 6.1 (± 1.6) cmH2O. Minute ventilation was 9.0 (± 3.1) L/min with a respiratory rate of 17.4 (± 4.4) breaths/min. Patients were liberated from MV with a median [interquartile range] delay between initial screening and extubation of 5 [1-49] hours. Only 7 (8%) patients required reintubation. CONCLUSION: The trial algorithm permitted identification of 93 (25%) patients who were ready to extubate, while their clinicians predicted a duration of ventilation higher than 24 h.

Impact of Airway Humidification Strategy in Mechanically Ventilated COVID-19 Patients.

BACKGROUND: Humidification of inspiratory gases is mandatory in all mechanically ventilated patients in ICUs, either with heated humidifiers (HHs) or with heat and moisture exchangers (HMEs). In patients with COVID-19, the choice of the humidification device may have relevant impact on patients' management as demonstrated in recent studies. We reported data from 2 ICUs using either HME or HH. METHODS: Data from patients with COVID-19 requiring invasive mechanical ventilation during the first wave in 2 ICUs in Québec City were reviewed. In one ICU, HMEs were used, whereas heated-wire HHs were used in the other ICU. We compared ventilator settings and arterial blood gases at day one after adjustment of ventilator settings. Episodes of endotracheal tube occlusions (ETOs) or subocclusions and a strategy to limit the risk of under-humidification were reported. On a bench test, we measured humidity with psychrometry with HH at different ambient temperature and evaluated the relation with heater plate temperature. RESULTS: We reported data from 20 subjects positive for SARS-Cov-2, including 6 in the ICU using HME and 14 in the ICU using HH. In the HME group, PaCO2 was higher (48 vs 42 mm Hg) despite higher minute ventilation (171 vs 145 mL/kg/min predicted body weight [PBW]). We also reported 3 ETOs occurring in the ICU using HH. The hygrometric bench study reported a strong correlation between heater plate temperatures of the HH and humidity delivered. After implementation of measures to avoid under-humidification, including heater plate temperature monitoring, no more ETOs occurred. CONCLUSIONS: The choice of the humidification device used in subjects with COVID-19 had a relevant impact on ventilation efficiency (increased CO2 removal with lower dead space) and on complications related to low humidity, including ETOs that may be present with heated-wire HHs when used with high ambient temperatures.

Hygrometric Performances of Different High-Flow Nasal Cannula Devices: Bench Evaluation and Clinical Tolerance.

BACKGROUND: High-flow nasal cannula (HFNC) is increasingly used for the management of respiratory failure. Settings include [Formula: see text], total gas flow, and temperature target. Resulting absolute humidity (AH) at the nasal cannula may affect clinical tolerance, and optimal settings with respect to hygrometry remain poorly documented. METHODS: A bench study was designed to assess AH delivered by 4 HFNC devices (Optiflow, Airvo 2, Precision Flow, and Hydrate) according to flow, ambient temperature, and other available settings. Clinical tolerance of different levels of hygrometry (20, 30, and 40 mg H2O/L) was evaluated in 15 healthy volunteers. RESULTS: With [Formula: see text] set at 1.0, normal ambient temperature, and settings made accordingly to the manufacturers' recommendations, mean ± SD AH was 42.2 ± 3.1, 39.5 ± 1.8, 35.7 ± 2.0, and 32.9 ± 2.7 mg H2O/L for the Airvo 2, Optiflow, Hydrate, and Precision Flow, respectively, (P < .001). AH dropped from -3.5 to -10.7 mg H2O/L (P <. 001) with high ambient temperature, except for the Precision Flow. Increasing flow did not significantly affect AH except for the Precision Flow (from 36.4 ± 1.6 to 29.8 ± 0.2 mg H2O/L at 10 and 40 L/min, respectively, [P < .001]). The lowest AH was encountered with the Optiflow set with noninvasive ventilation (NIV) mode, without compensation algorithm, and at high ambient temperature (14.2 ± 1.5 mg H2O/L). In studied subjects, AH significantly affected breathing comfort, reduced from 7.0 ± 1.0 to 3.0 ± 2.0 at 40 and 20 mg H2O/L, respectively, (P < .001). Comfort was similar at 30 and 40 mg H2O/L. CONCLUSIONS: When used according to manufacturer's recommendations and at normal ambient temperature, all the HFNC devices evaluated achieved satisfactory hygrometric output with respect to breathing comfort evaluated in healthy subjects (≥ 30 mg H2O/L). Substantial differences exist between devices, and optimal knowledge of their working principles is required as inappropriate usage may dramatically alter efficacy and clinical tolerance.

Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study.

INTRODUCTION: Hypoxaemia and hyperoxaemia may occur after surgery, with related complications. This multicentre randomised trial evaluated the impact of automated closed-loop oxygen administration after high-risk abdominal or thoracic surgeries in terms of optimising the oxygen saturation measured by pulse oximetry time within target range. METHODS: After extubation, patients with an intermediate to high risk of post-operative pulmonary complications were randomised to "standard" or "automated" closed-loop oxygen administration. The primary outcome was the percentage of time within the oxygenation range, during a 3-day frame. The secondary outcomes were the time with hypoxaemia and hyperoxaemia under oxygen. RESULTS: Among the 200 patients, time within range was higher in the automated group, both initially (≤3 h; 91.4±13.7% versus 40.2±35.1% of time, difference +51.0% (95% CI -42.8-59.2%); p<0.0001) and during the 3-day period (94.0±11.3% versus 62.1±23.3% of time, difference +31.9% (95% CI 26.3-37.4%); p<0.0001). Periods of hypoxaemia were reduced in the automated group (≤3 days; 32.6±57.8 min (1.2±1.9%) versus 370.5±594.3 min (5.0±11.2%), difference -10.2% (95% CI -13.9--6.6%); p<0.0001), as well as hyperoxaemia under oxygen (≤3 days; 5.1±10.9 min (4.8±11.2%) versus 177.9±277.2 min (27.0±23.8%), difference -22.0% (95% CI -27.6--16.4%); p<0.0001). Kaplan-Meier analysis depicted a significant difference in terms of hypoxaemia (p=0.01) and severe hypoxaemia (p=0.0003) occurrence between groups in favour of the automated group. 25 patients experienced hypoxaemia for >10% of the entire monitoring time during the 3 days within the standard group, as compared to the automated group (p<0.0001). CONCLUSION: Automated closed-loop oxygen administration promotes greater time within the oxygenation target, as compared to standard manual administration, thus reducing the occurrence of hypoxaemia and hyperoxaemia.

Physiologic Effects of High-Flow Nasal Cannula in Healthy Subjects.

BACKGROUND: High-flow nasal cannula (HFNC) is increasingly used in the management of acute and chronic respiratory failure. Little is known about the optimal settings for HFNC. This study was designed to assess the dose effect of HFNC on respiratory effort indexes and respiratory patterns in spontaneously breathing adults. METHODS: A randomized controlled crossover study was conducted in 10 healthy subjects. Five experimental conditions were evaluated: baseline with no therapy; 5 L/min with conventional nasal prongs; and HFNC at 20, 40, and 60 L/min. The primary outcomes were the indexes of respiratory effort (ie, esophageal pressure swing [ΔPes], esophageal pressure-time product, and work of breathing). Secondary outcomes included breathing pattern parameters and blood gases. Dead-space ventilation and washout were calculated based on minute ventilation, breathing frequency, and Radford equations. RESULTS: ΔPes increased from median (interquartile range [IQR] 3.2 (2.2-3.6) cm H2O at baseline to median (IQR) 5.7 (4.6-6.8) cm H2O at 60 L/min (P < .001). Neither esophageal pressure-time product nor work of breathing were modified during the tested conditions. The minute volume was significantly reduced at 40 and 60 L/min compared with baseline (P = .04), mostly driven by an important and dose-dependent reduction in breathing frequency, from median (IQR) 16 (15-18) breaths/min at baseline, to median (IQR) 8 (7-10) breaths/min at 60 L/min (P < .001). Capillary [Formula: see text] was stable in all the tested conditions. The calculated dead-space ventilation was reduced by half with HFNC. CONCLUSIONS: HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).

Oxygen Conservation Methods With Automated Titration.

BACKGROUND: Oxygen titration is recommended to avoid hyperoxemia and hypoxemia. Automated titration, as well as the [Formula: see text] target, may have an impact on oxygen utilization, with potential logistical effects in emergency and military transportation. We sought to assess the oxygen flow required for different [Formula: see text] targets in spontaneously breathing subjects, and to evaluate individualized automated oxygen titration to maintain stable oxygenation in subjects with COPD and healthy subjects with induced hypoxemia. METHODS: In the first part of the study, oxygen flow was evaluated in hospitalized subjects for different [Formula: see text] targets from 90% to 98%. Oxygen requirements to reach these targets were determined using a device that automatically adjusts oxygen flow every second on the basis of the [Formula: see text] target. In the second part of the study, the same automated oxygen titration method was used to correct hypoxemia in subjects with COPD and in healthy subjects with induced hypoxemia while the subjects wore a gas mask. Oxygen flow, [Formula: see text], and heart rate were continuously recorded. RESULTS: Thirty-six spontaneously breathing hospitalized subjects were included in the first part of the study. Oxygen flow was reduced more than 6-fold when the [Formula: see text] target was decreased from 98% to 90%. The second part of the study included 15 healthy and 9 subjects with stable COPD. In healthy subjects, heterogeneous oxygen flows were required to correct induced hypoxemia (0.2-2.5 L/min). In subjects with COPD, oxygen flow varied from 0 L/min (in 9 of 18 tested conditions) to 2.9 L/min. CONCLUSIONS: Significant reductions in the amount of oxygen delivered could be obtained with optimized [Formula: see text] targets. Oxygen delivery through a gas mask to correct hypoxemia is feasible, and automated oxygen titration may help individualize oxygen administration and reduce oxygen utilization. (ClinicalTrials.gov registration: NCT02782936, NCT02809807.).

Evaluation of hyperoxia-induced hypercapnia in obese patients after cardiac surgery: a randomized crossover comparison of conservative and liberal oxygen administration.

PURPOSE: Recent studies on patients with stable obesity-hypoventilation syndrome have raised concerns about hyperoxia-induced hypercapnia in this population. This study aimed to evaluate whether a higher oxygen saturation target would increase arterial partial pressure of carbon dioxide (PaCO2) in obese patients after coronary artery bypass grafting surgery (CABG). METHODS: Obese patients having CABG were recruited. With a randomized crossover design, we compared two oxygenation strategies for 30 min each, immediately after extubation: a peripheral oxygen saturation (SpO2) target of ≥ 95% achieved with manual oxygen titration (liberal) and a SpO2 target of 90% achieved with FreeO2, an automated oxygen titration device (conservative). The main outcome was end-of-period arterial PaCO2. RESULTS: Thirty patients were included. Mean (standard deviation [SD]) body mass index (BMI) was 34 (3) kg·m-2 and mean (SD) baseline partial pressure of carbon dioxide (PCO2) was 40.7 (3.1) mmHg. Mean (SD) end-of-period PaCO2 was 42.0 (5.4) mmHg in the conservative period, compared with 42.6 (4.6) mmHg in the liberal period [mean difference - 0.6 (95% confidence interval - 2.2 to 0.9) mmHg; P = 0.4]. Adjusted analysis for age, BMI, narcotics, and preoperative PaCO2 did not substantively change the results. Fourteen patients were retainers, showing an elevation in mean (SD) PaCO2 in the liberal period of 3.3 (4.1) mmHg. Eleven patients had the opposite response, with a mean (SD) end-of-period PaCO2 decrease of 1.8 (2.2) mmHg in the liberal period. Five patients had a neutral response. CONCLUSION: This study did not show a clinically important increase in PaCO2 associated with higher SpO2 values in this specific population of obese patients after CABG. Partial pressure of carbon dioxide increased with liberal oxygen administration in almost half of the patients, but no predictive factor was identified. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT02917668); registered 25 September, 2016.

Impact of Gas Masks on the Work of Breathing and Breathing Pattern in Subjects With Stable COPD.

BACKGROUND: The gas mask constitutes the main respiratory protective equipment in a chemical, biological, radiological, or nuclear environment. The aim of the study was to evaluate the impact of the gas mask on respiratory pattern, gas exchange, and indexes of respiratory effort in patients with moderate to severe stable COPD. METHODS: Crossover evaluation with 3 randomized-order, 10-min conditions: at rest and with and without a gas mask using 2 different filtered cartridges, each with a distinct inspiratory resistance (cartridge A = 3.5 cm H2O; cartridge B = 2.2 cm H2O, both at 1 L/s). The study involved 8 subjects with COPD, and breathing patterns, indexes of respiratory effort, and capillary blood gases were evaluated. Comparisons of these parameters were made between the tested conditions. RESULTS: Mean subject age was 69 y, and mean FEV1 = 1.3 L (47% predicted). Short-term utilization of the gas mask was associated with a significant increase in the indexes of effort in comparison to baseline without a mask. The esophageal product-time product significantly increased in comparison with baseline (cartridge A = 281 ± 65 cm H2O/s/min, cartridge B = 253 ± 47 cm H2O/s/min, and baseline = 184 ± 46 cm H2O/s/min, P < .001). There were negligible changes in the breathing pattern and gas exchange. CONCLUSIONS: Indexes of respiratory effort increased slightly in subjects with stable COPD while using a gas mask. This effect was likely related to increased inspiratory resistance when the mask was worn. These data are reassuring for the potential short-duration use of such protection for patients with moderate to severe COPD.

Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study.

INTRODUCTION: Hypoxemia and hyperoxia may occur after surgery with potential related complications. The FreeO2 PostOp trial is a prospective, multicentre, randomised controlled trial that evaluates the clinical impact of automated O2 administration versus conventional O2 therapy after major abdominal or thoracic surgeries. The study is powered to demonstrate benefits of automated oxygen titration and weaning in term of oxygenation, which is an important surrogate for complications after such interventions. METHODS AND ANALYSIS: After extubation, patients are randomly assigned to the Standard (manual O2 administration) or FreeO2 group (automated closed-loop O2 administration). Stratification is performed for the study centre and a medical history of chronic obstructive pulmonary disease (COPD). Primary outcome is the percentage of time spent in the target zone of oxygen saturation, during a 3-day time frame. In both groups, patients will benefit from continuous oximetry recordings. The target zone of oxygen saturation is SpO2=88%-92% for patients with COPD and 92%-96% for patients without COPD. Secondary outcomes are the nursing workload assessed by the number of manual O2 flow adjustments, the time spent with severe desaturation (SpO2 <85%) and hyperoxia area (SpO2 >98%), the time spent in a hyperoxia area (SpO2 >98%), the VO2, the duration of oxygen administration during hospitalisation, the frequency of use of mechanical ventilation (invasive or non-invasive), the duration of the postrecovery room stay, the hospitalisation length of stay and the survival rate. ETHICS AND DISSEMINATION: The FreeO2 PostOp study is conducted in accordance with the declaration of Helsinki and was registered on 11 September 2015 (http://www.clinicaltrials.gov). First patient inclusion was performed on 14 January 2016. The results of the study will be presented at academic conferences and submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02546830.

Impact of Gas Masks on Work of Breathing, Breathing Patterns, and Gas Exchange in Healthy Subjects.

BACKGROUND: The gas mask is used to protect military and non-military personnel exposed to respiratory hazards (chemical, biologic, radiologic, and nuclear agents). The objective was to evaluate the impact of the gas mask on indexes of respiratory effort and breathing patterns in a human model because no data exist. METHODS: The design of the study was a crossover evaluation with four 10-min conditions in a randomized order: with and without wearing the gas mask when at rest and when exerting a standardized effort. During the studied conditions, 14 healthy subjects were evaluated for breathing patterns, indexes of respiratory effort (work of breathing, pressure-time product for esophageal pressure, and esophageal pressure swing) and capillary blood gases. Continuous SpO2 was recorded during the tested conditions. RESULTS: The indexes of respiratory effort significantly increased when subjects wore the gas mask under the tested conditions (at rest and during effort). The work of breathing was significantly augmented with the mask (at rest, 0.40 ± 0.32 J/cycle vs 0.25 ± 0.10 J/cycle; effort, 5.96 ± 3.32 J/cycle vs 4.43 ± 2.50 J/cycle; P < .001). The other indexes of effort (esophageal pressure-time product and esophageal swing were all significantly increased, from 30 to 60%, with a gas mask in comparison with at baseline without a gas mask). The impact on breathing patterns and PaCO2 was limited, without significant differences. Moderate hypoxemia was present during effort and was not increased by the gas mask. CONCLUSIONS: This study demonstrated a substantial increase in the indicies of respiratory effort both at rest and during exercise with a gas mask. Our measurements and findings may be referred in future research and development studies in this field. (ClinicalTrials.gov registration NCT02782936.).

Cost-effectiveness of FreeO2 in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec.

OBJECTIVE: Conduct a cost-effectiveness analysis of FreeO2 technology versus manual oxygen-titration technology for patients with chronic obstructive pulmonary disease (COPD) hospitalised for acute exacerbations. SETTING: Tertiary acute care hospital in Quebec, Canada. PARTICIPANTS: 47 patients with COPD hospitalised for acute exacerbations. INTERVENTION: An automated oxygen-titration and oxygen-weaning technology. METHODS AND OUTCOMES: The costs for hospitalisation and follow-up for 180 days were calculated using a microcosting approach and included the cost of FreeO2 technology. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap resampling with 5000 replications. The main effect variable was the percentage of time spent at the target oxygen saturation (SpO2). The other two effect variables were the time spent in hyperoxia (target SpO2+5%) and in severe hypoxaemia (SpO2 <85%). The resamplings were based on data from a randomised controlled trial with 47 patients with COPD hospitalised for acute exacerbations. RESULTS: FreeO2 generated savings of 20.7% of the per-patient costs at 180 days (ie, -$C2959.71). This decrease is nevertheless not significant at the 95% threshold (P=0.13), but the effect variables all improved (P<0.001). The improvement in the time spent at the target SpO2 was 56.3%. The ICERs indicate that FreeO2 technology is more cost-effective than manual oxygen titration with a savings of -$C96.91 per percentage point of time spent at the target SpO2 (95% CI -301.26 to 116.96). CONCLUSION: FreeO2 technology could significantly enhance the efficiency of the health system by reducing per-patient costs at 180 days. A study with a larger patient sample needs to be carried out to confirm these preliminary results. TRIAL REGISTRATION NUMBER: NCT01393015; Post-results.

Effects of High-Flow Nasal Cannula on the Work of Breathing in Patients Recovering From Acute Respiratory Failure.

OBJECTIVES: High-flow nasal cannula is increasingly used in the management of respiratory failure. However, little is known about its impact on respiratory effort, which could explain part of the benefits in terms of comfort and efficiency. This study was designed to assess the effects of high-flow nasal cannula on indexes of respiratory effort (i.e., esophageal pressure variations, esophageal pressure-time product/min, and work of breathing/min) in adults. DESIGN: A randomized controlled crossover study was conducted in 12 patients with moderate respiratory distress (i.e., after partial recovery from an acute episode, allowing physiologic measurements). SETTING: Institut Universitaire de Cardiologie et de Pneumologie de Québec, QC, Canada. SUBJECTS: Twelve adult patients with respiratory distress symptoms were enrolled in this study. INTERVENTIONS: Four experimental conditions were evaluated: baseline with conventional oxygen therapy and high-flow nasal cannula at 20, 40, and 60 L/min. The primary outcomes were the indexes of respiratory effort (i.e., esophageal pressure variations, esophageal pressure-time product/min, and work of breathing/min). Secondary outcomes included tidal volume, respiratory rate, minute volume, dynamic lung compliance, inspiratory resistance, and blood gases. MEASUREMENTS AND MAIN RESULTS: Esophageal pressure variations decreased from 9.8 (5.8-14.6) cm H2O at baseline to 4.9 (2.1-9.1) cm H2O at 60 L/min (p = 0.035). Esophageal pressure-time product/min decreased from 165 (126-179) to 72 (54-137) cm H2O • s/min, respectively (p = 0.033). Work of breathing/min decreased from 4.3 (3.5-6.3) to 2.1 (1.5-5.0) J/min, respectively (p = 0.031). Respiratory pattern variables and capillary blood gases were not significantly modified between experimental conditions. Dynamic lung compliance increased from 38 (24-64) mL/cm H2O at baseline to 59 (43-175) mL/cm H2O at 60 L/min (p = 0.007), and inspiratory resistance decreased from 9.6 (5.5-13.4) to 5.0 (1.0-9.1) cm H2O/L/s, respectively (p = 0.07). CONCLUSIONS: High-flow nasal cannula, when set at 60 L/min, significantly reduces the indexes of respiratory effort in adult patients recovering from acute respiratory failure. This effect is associated with an improvement in respiratory mechanics.