Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial.
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SUBMITTER: Kofod LM
PROVIDER: S-EPMC8584500 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:This study evaluated the effects of aclidinium bromide, a long-acting muscarinic antagonist indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD), on exercise endurance, dyspnea, lung hyperinflation, and physical activity.In this randomized, double-blind, crossover study, patients with stable COPD and moderate-to-severe airflow limitation received aclidinium 400 ?g twice daily or placebo via Genuair®/Pressair(®a) for 3 weeks (2-week washout between treatment periods). The primary endpoint was change from baseline to Week 3 in endurance time, measured by constant work rate cycle ergometry testing at 75% peak incremental work rate. Changes from baseline in intensity of exertional dyspnea (Borg CR10 Scale®) and trough inspiratory capacity were secondary endpoints. Additional endpoints included changes from baseline in other spirometric, plethysmographic, and physical activity (assessed by objective accelerometer measurement) parameters. Efficacy endpoints were analyzed using an analysis of covariance model.In total, 112 patients were randomized and treated (mean age 60.3 years; mean post-bronchodilator forced expiratory volume in 1 s 1.7 L [56.7% predicted]; mean endurance time 485.7 s). After 3 weeks, endurance time was significantly increased with aclidinium versus placebo (treatment difference 58.5 s; p?<?0.05). At Week 3, aclidinium significantly reduced dyspnea intensity at isotime during exercise (treatment difference -0.63; p?<?0.05) and improved trough inspiratory capacity (treatment difference 78 mL; p?<?0.05) versus placebo. Significant improvements in spirometric, plethysmographic, and some physical activity parameters were observed with aclidinium versus placebo.These results suggest that aclidinium significantly improves exercise endurance, exertional dyspnea, hyperinflation, and physical activity in patients with COPD.ClinicalTrials.gov identifier: NCT01471171; URL: http://www.clinicaltrials.gov.
| S-EPMC4364572 | biostudies-literature
Project description:IntroductionWe developed a device (FreeO2) that automatically adjusts the oxygen flow rates based on patients' needs, in order to limit hyperoxia and hypoxemia and to automatically wean them from oxygen.ObjectiveThe aim of this study was to evaluate the feasibility of using FreeO2 in patients hospitalized in the respiratory ward for an acute exacerbation of COPD.MethodsWe conducted a randomized controlled trial comparing FreeO2 vs manual oxygen titration in the respiratory ward of a university hospital. We measured the perception of appropriateness of oxygen titration and monitoring in both groups by nurses and attending physicians using a Likert scale. We evaluated the time in the target range of oxygen saturation (SpO2) as defined for each patient by the attending physician, the time with severe desaturation (SpO2 <85%), and the time with hyperoxia (SpO2 >5% above the target). We also recorded length of stay, intensive care unit admissions, and readmission rate. Fifty patients were randomized (25 patients in both groups; mean age: 72±8 years; mean forced expiratory volume in 1 second: 1.00±0.49 L; and mean initial O2 flow 2.0±1.0 L/min).ResultsNurses and attending physicians felt that oxygen titration and monitoring were equally appropriate with both O2 administration systems. The percentage of time within the SpO2 target was significantly higher with FreeO2, and the time with severe desaturation and hyperoxia was significantly reduced with FreeO2. Time from study inclusion to hospital discharge was 5.8±4.4 days with FreeO2 and 8.4±6.0 days with usual oxygen administration (P=0.051).ConclusionFreeO2 was deemed as an appropriate oxygen administration system by nurses and physicians of a respiratory unit. This system maintained SpO2 at the target level better than did manual titration and reduced periods of desaturation and hyperoxia. Our results also suggest that FreeO2 has the potential to reduce the hospital length of stay.
| S-EPMC5003517 | biostudies-literature
Project description:Introduction: Ambulatory oxygen therapy is indicated in patients that use long term oxygen therapy (LTOT) and current guidelines suggest its use in patients who exhibit exertional desaturation if there is a demonstrable improvement in exercise capacity. Evidence for this is largely derived from single assessment studies which have shown clear benefit in this setting when oxygen versus air is used. The long term effects, however, of ambulatory oxygen therapy in this particular group of patients is controversial. Methods: We conducted a systematic review of published literature from 1980 to June 2014 for trials in which ambulatory oxygen was compared to placebo in chronic obstructive pulmonary disease (COPD) patients not on LTOT. We also reviewed the effectiveness of devices delivering ambulatory oxygen. Outcome measures were focused towards exercise capacity, Borg scores and the ability of the delivery devices to maintain oxygen saturations on exercise. Results: Twenty three studies (620 patients) were included in the review. Nine studies evaluated the clinical effectiveness of ambulatory oxygen and 14 studies evaluated the impact of the delivery devices. Ambulatory oxygen had no statistical effect on improving exercise capacity when assessed by the 6-minute walk test (6MWT) or the endurance shuttle walk test (ESWT);p=0.44 and p=0.29 respectively. End of test Borg scores showed no statistical improvement with ambulatory oxygen therapy during 6MWT (p=0.68). Oxygen conserving devices significantly improved oxygen saturations on exercise compared with continuous flow nasal cannulae (p=0.04). Conclusion: Ambulatory oxygen therapy has limited long term benefit in improving functional exercise capacity or Borg dyspnea scores.
| S-EPMC5559123 | biostudies-literature
Project description:The aim of this study was to determine if there is a difference in 6-min walk test (6MWT) distance when the assessor accompanies the patient to continuously measure peripheral oxygen saturation (SpO2 ) compared to the patient walking unaccompanied. We conducted a randomised crossover study to evaluate the impact of the assessor walking with the patient during the 6MWT (6MWTwith) versus the patient walking alone (6MWTwithout). At the end of a pulmonary rehabilitation programme, each patient performed two 6MWTs in random order and separated by a 30-min rest. 49 patients with chronic obstructive pulmonary disease (COPD) (Global Initiative for Obstructive Lung Disease classification II-IV) were included. In a regression model adjusting for period and subject, accompanying the patient resulted in a lower walking distance (mean difference -9.1 m, 95% CI -13.9- -4.3, p=0.0004). Notably, six patients walked more than 30 m farther (minimal important difference) in one of the two conditions (6MWTwith: n=1, 6MWTwithout: n=5). There were no between-sequence-group differences in heart rate, dyspnoea, leg fatigue and SpO2 . The median (interquartile range) number and duration of SpO2 signal artefacts were high but not different between the experimental conditions (6MWTwith: 17 (4-24), 34 s (7-113 s); 6 MWTwithout: 11 (3-26), 24 s (4-62 s)). At a study population level, we observed a statistically significant difference in 6MWT distance between the two experimental conditions; however, the magnitude of difference was small and may not be clinically relevant. Nevertheless, in a clinical setting, unaccompanied walking resulted in a substantially higher walking distance in individual patients, pointing towards strictly standardised testing methodology, in particular in pre-post study designs.
| S-EPMC8326679 | biostudies-literature
Project description:Current oxygen delivery modes lack monitoring and can be cumbersome for patients with chronic respiratory diseases. Integrating a pulse oximeter and nasal oxygen cannulas into eyeglasses would reduce the burden of current solutions. An ear pulse oximeter (OxyFrame) was evaluated on 16 healthy volunteers and 20 hypoxemic patients with chronic respiratory diseases undergoing a prespecified protocol simulating daily activities. Correlation, error, and accuracy root mean square error (ARMS) were calculated to compare SpO2 measured by OxyFrame, a standard pulse oximeter (MASIMO), and arterial blood gas analysis (aBGA). SpO2 measured by OxyFrame and MASIMO correlated strongly in volunteers, with low error and high accuracy (r = 0.85, error = 0.2 ± 2.9%, ARMS = 2.88%). Performances were similar in patients (r = 0.87, error 0 ± 2.5%, ARMS = 2.49% compared with MASIMO; and r = 0.93, error = 0.4 ± 1.9%, ARMS = 1.94% compared with aBGA). However, the percentage of rejected measurements was high (volunteers 77.2%, patients 46.9%). The OxyFrame cavum conchae pulse oximeter was successfully evaluated, and demonstrated accurate SpO2 measurements, compliant with ISO 80601-2-61:2017. Several reasons for the high rejection rate were identified, and potential solutions were proposed, which might be valuable for optimization of the sensor hardware.
| S-EPMC7308892 | biostudies-literature
Project description:IntroductionWe aimed to compare automated ventilation with closed-loop control of the fraction of inspired oxygen (FiO2) to automated ventilation with manual titrations of the FiO2 with respect to time spent in predefined pulse oximetry (SpO2) zones in pediatric critically ill patients.MethodsThis was a randomized crossover clinical trial comparing Adaptive Support Ventilation (ASV) 1.1 with use of a closed-loop FiO2 system vs. ASV 1.1 with manual FiO2 titrations. The primary endpoint was the percentage of time spent in optimal SpO2 zones. Secondary endpoints included the percentage of time spent in acceptable, suboptimal and unacceptable SpO2 zones, and the total number of FiO2 changes per patient.ResultsWe included 30 children with a median age of 21 (11-48) months; 12 (40%) children had pediatric ARDS. The percentage of time spent in optimal SpO2 zones increased with use of the closed-loop FiO2 controller vs. manual oxygen control [96.1 (93.7-98.6) vs. 78.4 (51.3-94.8); P < 0.001]. The percentage of time spent in acceptable, suboptimal and unacceptable zones decreased. Findings were similar with the use of closed-loop FiO2 controller compared to manual titration in patients with ARDS [95.9 (81.6-98.8) vs. 78 (49.5-94.8) %; P = 0.027]. The total number of closed-loop FiO2 changes per patient was 52 (11.8-67), vs. the number of manual changes 1 (0-2), (P < 0.001).ConclusionIn this randomized crossover trial in pediatric critically ill patients under invasive ventilation with ASV, use of a closed-loop control of FiO2 titration increased the percentage of time spent within in optimal SpO2 zones, and increased the total number of FiO2 changes per patient.Clinical trial registrationClinicalTrials.gov, identifier: NCT04568642.
| S-EPMC9452913 | biostudies-literature
Project description:Purpose:It is a challenge to control oxygen saturation (SpO2) in patients with exacerbations of COPD during admission. We tested a newly developed closed-loop system, O2matic®, and its ability to keep SpO2 within a specified interval compared with manual control by nursing staff. Patients and methods:We conducted a crossover trial with patients admitted with an exacerbation of COPD and hypoxemia (SpO2 ?88% on room air). Patients were monitored with continuous measurement of SpO2. In random order, they had 4 hours with manually controlled oxygen and 4 hours with oxygen delivery controlled by O2matic. Primary outcome was time within a prespecified SpO2 target interval. Secondary outcomes were time with SpO2 <85%, time with SpO2 below target but not <85%, and time with SpO2 above target. Results:Twenty patients were randomized and 19 completed the study. Mean age was 72.4 years and mean FEV1 was 0.72 L (33% of predicted). Patients with O2matic-controlled treatment were within the SpO2 target interval in 85.1% of the time vs 46.6% with manually controlled treatment (P<0.001). Time with SpO2 <85% was 1.3% with O2matic and 17.9% with manual control (P=0.01). Time with SpO2 below target but not <85% was 9.0% with O2matic and 25.0% with manual control (P=0.002). Time with SpO2 above target was not significantly different between treatments (4.6% vs 10.5%, P=0.2). Patients expressed high confidence and a sense of safety with automatic oxygen delivery. Conclusion:O2matic was able to effectively control SpO2 for patients admitted with an exacerbation of COPD. O2matic was significantly better than manual control to maintain SpO2 within target interval and to reduce time with unintended hypoxemia.
| S-EPMC6300382 | biostudies-literature
Project description:BACKGROUND: Patients with COPD use a higher proportion of their peak aerobic capacity during the performance of domestic activities of daily life (ADLs) compared to healthy peers, accompanied by a higher degree of task-related symptoms. To date, the influence of body mass index (BMI) on the task-related metabolic demands remains unknown in patients with COPD. Therefore, the aim of our study was to determine the effects of BMI on metabolic load during the performance of 5 consecutive domestic ADLs in patients with COPD. METHODOLOGY: Ninety-four COPD patients and 20 healhty peers performed 5 consecutive, self-paced domestic ADLs putting on socks, shoes and vest; folding 8 towels; putting away groceries; washing up 4 dishes, cups and saucers; and sweeping the floor for 4 min. Task-related oxygen uptake and ventilation were assessed using a mobile oxycon, while Borg scores were used to assess task-related dyspnea and fatigue. PRINCIPAL FINDINGS: 1. Relative task-related oxygen uptake after the performance of domestic ADLs was increased in patients with COPD compared to healthy elderly, whereas absolute oxygen uptake is similar between groups; 2. Relative oxygen uptake and oxygen uptake per kilogram fat-free mass were comparable between BMI groups; and 3. Borg symptom scores for dyspnea en fatigue were comparable between BMI groups. CONCLUSION: Patients with COPD in different BMI groups perform self-paced domestic ADLs at the same relative metabolic load, accompanied by comparable Borg symptom scores for dyspnea and fatigue.
| S-EPMC3398871 | biostudies-literature
Project description:Background: Electrocardiogram (ECG) contamination is present in diaphragm electromyography (EMGdi) recordings. Obtaining EMGdi without ECG contamination is crucial for EMG amplitude analysis. Manually selecting EMGdi in between QRS complexes has been most commonly applied in recent years (manual method). We developed a semi-automated analysis method based on Least Mean Square Adaptive Filtering combined with a synchronously recorded separate ECG channel to remove ECG artifacts from the EMGdi signals. We hypothesized that this approach would shorten analysis duration and might minimize the potential for inter-rater disagreement. Aims: We aimed to evaluate agreement between the semi-automated method and the manual method and inter-rater reliability of the manual method. Methods: Electromyography signals of seven patients with COPD were recorded using an esophageal catheter during an exercise test on a cycle ergometer. Four patients subsequently participated in an inspiratory muscle training (IMT) program for 8 weeks. After IMT, the tests were repeated. EMGdi/EMGdiMax as obtained either manually by the two assessors or retrieved from the semi-automated method were compared. Results: Semi-automated EMGdi/EMGdiMax agreed well with values obtained by one of the two manual assessors (assessor 1) both at pre-intervention measurements (mean difference -0.5%, 95% CI: -19.6 to 18.6%) and for the pre/post IMT differences (mean difference 1.2%, 95% CI: -16.8 to 19.2%). Intra-class correlation coefficients between methods were 0.96 (95% CI: 0.94-0.97) at pre-intervention measurements and 0.78 (95% CI: 0.58-0.89) for pre/post IMT differences (both p < 0.001). EMGdi/EMGdiMax from assessor 2 was systematically lower than from assessor 1 and agreed less well with the semi-automated method both at pre-intervention measurements (mean difference: 9.3%, 95% CI: -11.4 to 29.9%) and for pre/post IMT differences (mean difference 7.0%, 95% CI: -20.4 to 34.4%). Analysis duration of the semi-automated method was significantly shorter (29 ± 9 min) than the manual method (82 ± 20 min, p < 0.001). Conclusion: The developed semi-automated method is more time efficient and will be less prone to inter-rater variability that was observed when applying the manual analysis method. It is, therefore, proposed as a new standard for objective EMGdi amplitude analyses in future studies.
| S-EPMC6637315 | biostudies-literature
Project description:BackgroundThe effect of high-flow oxygen (HFOx) and high-flow air (HFAir) on dyspnea in nonhypoxemic patients is not known. We assessed the effect of HFOx, HFAir, low-flow oxygen (LFOx), and low-flow air (LFAir) on dyspnea.Subjects, materials, and methodsThis double-blind, 4×4 crossover clinical trial enrolled hospitalized patients with cancer who were dyspneic at rest and nonhypoxemic (oxygen saturation >90% on room air). Patients were randomized to 10 minutes of HFOx, HFAir, LFOx, and LFAir in different orders. The flow rate was titrated between 20-60 L/minute in the high-flow interventions and 2 L/minute in the low-flow interventions. The primary outcome was dyspnea numeric rating scale (NRS) "now" where 0 = none and 10 = worst.ResultsSeventeen patients (mean age 51 years, 58% female) completed 55 interventions in a random order. The absolute change of dyspnea NRS between 0 and 10 minutes was -1.8 (SD 1.7) for HFOx, -1.8 (2.0) for HFAir, -0.5 (0.8) for LFOx, and - 0.6 (1.2) for LFAir. In mixed model analysis, HFOx provided greater dyspnea relief than LFOx (mean difference [95% confidence interval] -0.80 [-1.45, -0.15]; p = .02) and LFAir (-1.24 [-1.90, -0.57]; p < .001). HFAir also provided significantly greater dyspnea relief than LFOx (-0.95 [-1.61, -0.30]; p = .005) and LFAir (-1.39 [-2.05, -0.73]; p < .001). HFOx was well tolerated. Seven (54%) patients who tried all interventions blindly preferred HFOx and four (31%) preferred HFAir.ConclusionWe found that HFOx and HFAir provided a rapid and clinically significant reduction of dyspnea at rest in hospitalized nonhypoxemic patients with cancer. Larger studies are needed to confirm these findings (Clinicaltrials.gov: NCT02932332).Implications for practiceThis double-blind, 4×4 crossover trial examined the effect of oxygen or air delivered at high- or low-flow rates on dyspnea in hospitalized nonhypoxemic patients with cancer. High-flow oxygen and high-flow air were significantly better at reducing dyspnea than low-flow oxygen/air, supporting a role for palliation beyond oxygenation.
| S-EPMC8100563 | biostudies-literature