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Evaluating the ventilatory effect of transnasal humidified rapid insufflation ventilatory exchange in apnoeic small children with two different oxygen flow rates: a randomised controlled trial.
Riva, T, Préel, N, Theiler, L, Greif, R, Bütikofer, L, Ulmer, F, Seiler, S, Nabecker, S
Anaesthesia. 2021;(7):924-932
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Abstract
Transnasal humidified rapid insufflation ventilatory exchange prolongs safe apnoeic oxygenation time in children. In adults, transnasal humidified rapid insufflation ventilatory exchange is reported to have a ventilatory effect with PaCO2 levels increasing less rapidly than without it. This ventilatory effect has yet to be reproduced in children. In this non-inferiority study, we tested the hypothesis that children weighing 10-15 kg exhibit no difference in carbon dioxide clearance when comparing two different high-flow nasal therapy flow rates during a 10-min apnoea period. Following standardised induction of anaesthesia including neuromuscular blockade, patients were randomly allocated to high-flow nasal therapy of 100% oxygen at 2 or 4 l.kg-1 .min-1 . Airway patency was ensured by continuous jaw thrust. The study intervention was terminated for safety reasons when SpO2 values dropped < 95%, or transcutaneous carbon dioxide levels rose > 9.3 kPa, or near-infrared spectroscopy values dropped > 20% from their baseline values, or after an apnoeic period of 10 min. Fifteen patients were included in each group. In the 2 l.kg-1 .min-1 group, mean (SD) transcutaneous carbon dioxide increase was 0.46 (0.11) kPa.min-1 , while in the 4 l.kg-1 .min-1 group it was 0.46 (0.12) kPa.min-1 . The upper limit of a one-sided 95%CI for the difference between groups was 0.07 kPa.min-1 , lower than the predefined non-inferiority margin of 0.147 kPa.min-1 (p = 0.001). The lower flow rate of 2 l.kg-1 .min-1 was non-inferior to 4 l.kg-1 .min-1 relative to the transcutaneous carbon dioxide increase. In conclusion, an additional ventilatory effect of either 2 or 4 l.kg-1 .min-1 high-flow nasal therapy in apnoeic children weighing 10-15 kg appears to be absent.
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Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.
Frith, P, Sladek, R, Woodman, R, Effing, T, Bradley, S, van Asten, S, Jones, T, Hnin, K, Luszcz, M, Cafarella, P, et al
Chronic respiratory disease. 2020;:1479973119897277
Abstract
We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention (n = 100) and control (n = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68; p = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all p values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14; p = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction (p = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).
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Hyperoxia and antioxidants during major non-cardiac surgery and risk of cardiovascular events: Protocol for a 2 × 2 factorial randomised clinical trial.
Petersen, C, Loft, FC, Aasvang, EK, Vester-Andersen, M, Rasmussen, LS, Wetterslev, J, Jorgensen, LN, Christensen, R, Meyhoff, CS
Acta anaesthesiologica Scandinavica. 2020;(3):400-409
Abstract
BACKGROUND Myocardial injury after non-cardiac surgery occurs in a high number of patients, resulting in increased mortality in the post-operative period. The use of high inspiratory oxygen concentrations may cause hyperoxia, which is associated with impairment of coronary blood flow. Furthermore, the surgical stress response increases reactive oxygen species, which is involved in several perioperative complications including myocardial injury and death. Avoidance of hyperoxia and substitution of reactive oxygen species scavengers may be beneficial. Our primary objective is to examine the effect of oxygen and added antioxidants for prevention of myocardial injury assessed by area under the curve for troponin measurements during the first three post-operative days. METHODS The VIXIE trial (VitamIn and oXygen Interventions and cardiovascular Events) is an investigator-initiated, blinded, 2 × 2 factorial multicentre clinical trial. We include 600 patients with cardiovascular risk factors undergoing major non-cardiac surgery. Participants are randomised to an inspiratory oxygen fraction of 0.80 or 0.30 during and for 2 hours after surgery and either an intravenous bolus of vitamin C and an infusion of N-acetylcysteine or matching placebo of both. The primary outcome is the area under the curve for high-sensitive cardiac troponin release during the first three post-operative days as a marker of the extent of myocardial injury. Secondary outcomes are mortality, non-fatal myocardial infarction and non-fatal serious adverse events within 30 days. PERSPECTIVE The current trial will provide further evidence for clinicians on optimal administration of perioperative oxygen in surgical patients with cardiovascular risks and the clinical effects of two common antioxidants.
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Comparing the effects of 3 oxygen delivery methods plus intravenous ketorolac on primary headaches: A randomized clinical trial.
Saeedi, M, Shahvaran, SM, Ramezani, M, Rafiemanesh, H, Karimialavijeh, E
The American journal of emergency medicine. 2020;(1):55-59
Abstract
OBJECTIVE To compare three different oxygen therapy methods in primary headaches. METHODS Design: A randomized placebo-controlled clinical trial was conducted between January 2016 and October 2017. SETTING The emergency department of a university-affiliated urban hospital in Tehran, Iran. PARTICIPANTS Adult patients (aged 18 years and above) with moderate and severe primary headaches (VAS score of 4 or more). INTERVENTIONS Participants were allocated to one of four groups. Group A (n = 34) received 30 mg of intravenous ketorolac plus oxygen at 15 l/min (min) through a non-rebreather mask (NRB), group B (n = 34) received 30 mg of intravenous ketorolac plus 7 l/min of oxygen through a 60% venturi mask, group C (n = 34) received 30 mg of intravenous ketorolac plus 4 l/min of oxygen through a nasal cannula and group D (n = 34) received 30 mg of intravenous ketorolac and room air. MAIN OUTCOMES MEASURED Pain was assessed using the visual analog scale (VAS) at 0, 15, 30 and 60 min after admission. RESULTS Altogether, 136 patients were included. The most significant VAS change occurred in the NRB group at 30 min (p-value = 0.001). At this point, pain reduction in the NRB group was clinically higher than for the venturi and nasal cannula groups, but this effect had disappeared at 60 min. CONCLUSION Although the non-rebreather mask was significantly more effective at 30 min, after 60 min, none of the groups met the endpoint criterion of a 1.3-cm difference on the VAS scale.
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Intermittent Hypoxia/Hyperoxia Versus Intermittent Hypoxia/Normoxia: Comparative Study in Prediabetes.
Serebrovska, TV, Grib, ON, Portnichenko, VI, Serebrovska, ZO, Egorov, E, Shatylo, VB
High altitude medicine & biology. 2019;(4):383-391
Abstract
Background: Intermittent hypoxia/normoxia training (IHT) is considered a possible means to alleviate chronic diseases such as diabetes. In the last decade, another method of intermittent hypoxia/hyperoxia training (IHHT) began to enter the clinical practice, when the periods of breathing with atmospheric air are replaced by breathing a hyperoxic mixture. The present study compared the impact of adaptation to IHHT versus IHT on some metabolic variables in prediabetic patients. Methods: A placebo-controlled trial included 55 patients with prediabetes, sea level residents, ages 51-74 years. Control Group (16 patients) took sham 3-week course, and the IHHT Group (17 patients) and IHT Group (22 patients) received similar actual sessions of IHHT or IHT five times a week for 3 weeks, each session consisting four cycles of 5 minutes of hypoxia (12% O2) followed by 3 minutes of hyperoxia (IHHT, 33% O2) or 5 minutes of normoxia (IHT, breathing room air). Fasting glucose, oral glucose tolerance test (OGTT), blood lipids, and the level of blood oxygen saturation (SpO2) were investigated at baseline, as well as 1 day and 1 month after IHHT/IHT termination. Results: The study showed the same positive effect of two types of training: equal reduction of serum glucose concentrations, both fasting and 2 hours of OGTT; decreased total blood cholesterol and low-density lipoproteins; and an equally smaller drop in SpO2 during acute hypoxic test (breathing with 12% O2 for 20 minutes). Improved parameters persisted 1 month after training termination in both groups. Conclusion: One of the advantages of IHHT over IHT observed in this study could be some reduction in the duration of the sessions due to shortening reoxygenation periods. Further studies are required to search for additional beneficial effects of IHHT when using other training modes or other pathologies.
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An international comparison of retinopathy of prematurity grading performance within the Benefits of Oxygen Saturation Targeting II trials.
Fleck, BW, Williams, C, Juszczak, E, Cocker, K, Stenson, BJ, Darlow, BA, Dai, S, Gole, GA, Quinn, GE, Wallace, DK, et al
Eye (London, England). 2018;(1):74-80
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Abstract
PurposeTo investigate whether the observed international differences in retinopathy of prematurity (ROP) treatment rates within the Benefits of Oxygen Saturation Targeting (BOOST) II trials might have been caused by international variation in ROP disease grading.MethodsGroups of BOOST II trial ophthalmologists in UK, Australia, and New Zealand (ANZ), and an international reference group (INT) used a web based system to grade a selection of RetCam images of ROP acquired during the BOOST II UK trial. Rates of decisions to treat, plus disease grading, ROP stage grading, ROP zone grading, inter-observer variation within groups and intra-observer variation within groups were measured.ResultsForty-two eye examinations were graded. UK ophthalmologists diagnosed treat-requiring ROP more frequently than ANZ ophthalmologists, 13.9 (3.49) compared to 9.4 (4.46) eye examinations, P=0.038. UK ophthalmologists diagnosed plus disease more frequently than ANZ ophthalmologists, 14.1 (6.23) compared to 8.5 (3.24) eye examinations, P=0.021. ANZ ophthalmologists diagnosed stage 2 ROP more frequently than UK ophthalmologists, 20.2 (5.8) compared to 12.7 (7.1) eye examinations, P=0.026. There were no other significant differences in the grading of ROP stage or zone. Inter-observer variation was higher within the UK group than within the ANZ group. Intra-observer variation was low in both groups.ConclusionsWe have found evidence of international variation in the diagnosis of treatment-requiring ROP. Improved standardisation of the diagnosis of treatment-requiring ROP is required. Measures might include improved training in the grading of ROP, using an international approach, and further development of ROP image analysis software.
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Impact of continuous positive airway pressure and oxygen on health status in patients with coronary heart disease, cardiovascular risk factors, and obstructive sleep apnea: A Heart Biomarker Evaluation in Apnea Treatment (HEARTBEAT) analysis.
Lewis, EF, Wang, R, Punjabi, N, Gottlieb, DJ, Quan, SF, Bhatt, DL, Patel, SR, Mehra, R, Blumenthal, RS, Weng, J, et al
American heart journal. 2017;:59-67
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Abstract
INTRODUCTION Obstructive sleep apnea (OSA) is associated with impaired health-related quality of life (HRQL). Treatment with continuous positive airway pressure (CPAP) has variable impacts on HRQL, and this may be influenced by patient's tolerance of therapy. The objective is to determine the impact of nocturnal supplemental oxygen (NSO) and CPAP on HRQL compared with healthy lifestyle education (HLSE) in individuals with OSA. METHODS Patients with coronary heart disease (CHD) or at least 3 major CHD risk factors with apnea-hypopnea index of 15 to 50 events/h were randomized to CPAP, NSO, or HLSE. Health-related quality of life was assessed using the Short-Form 36, and depression was assessed with Patient Health Questionnaire-9 at baseline and 12 weeks. The treatment effect on HRQL change scores through 12 weeks was assessed using multivariable models adjusting for study site, presence of CHD at baseline, race, and baseline HRQL. RESULTS A total of 318 patients were randomized to 1 of 3 treatment arms with 1:1:1 ratio and 94% completed baseline and follow-up HRQL instruments. Mean Short-Form 36 scores were similar at baseline in all 3 groups ranging from 41.8±12 to 51.6±12 in various domains. In multivariable models, the CPAP group noted a significantly greater improvement than NSO in mental health (+2.33, 95% CI 0.34-4.31, P=.02) and mental composite score (+2.40, 95% CI 0.40-4.41, P=.02). Conversely, the CPAP group noted less improvement than NSO in physical function (-2.68, 95% CI -4.66 to -0.70, P=.008) and physical composite score (-2.17, 95% CI -3.82 to -0.51, P=.01). Compared with HLSE, vitality and Patient Health Questionnaire-9 improved with CPAP but not with NSO. Significant interactions were noted between treatment effects with larger differences in black and sleepy patients. CONCLUSION These data support the use of CPAP for improving vitality, sleepiness, mental health, social functioning, and depressive symptoms in patients with OSA and established CHD or risk factors. Nocturnal supplemental oxygen may have beneficial effects on perceived physical functioning.
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Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial.
Jarosch, I, Gloeckl, R, Damm, E, Schwedhelm, AL, Buhrow, D, Jerrentrup, A, Spruit, MA, Kenn, K
Chest. 2017;(4):795-803
Abstract
BACKGROUND The acute effect of supplemental oxygen during exercise has been shown to differ largely among patients with COPD. It is unknown what factors influence oxygen response. METHODS In a randomized, single-blind fashion, 124 patients with COPD underwent one 6-min walk test on supplemental oxygen (6MWTO2) and one 6-min walk test on room air after a practice 6-min walk test. Both gases were delivered via standard nasal prongs (2 L/min). For analyses, patients were stratified on the basis of PaO2 values and compared: (1) 34 patients with resting hypoxemia (HYX); (2) 43 patients with exercise-induced hypoxemia (EIH); and (3) 31 patients with normoxemia (NOX). RESULTS Oxygen supplementation resulted in an increase in the 6-min walk distance in the total cohort (27 ± 42 meters; P < .001) and in the subgroups of HYX (37 ± 40 meters; P < .001) and EIH (28 ± 44 meters; P < .001) but not in the NOX subgroup (15 ± 43 meters; P = .065). Forty-two percent of patients with HYX and 47% of patients with EIH improved their 6-min walk distance to a clinically relevant extent (≥ 30 meters) by using oxygen. These oxygen responders were characterized by significantly lower 6-min walk distance using room air compared with patients without a relevant response (306 ± 106 meters vs 358 ± 113 meters; P < .05). Although oxygen saturation was significantly higher during 6MWTO2 compared with the 6-min walk test on room air in all 3 subgroups, it dropped to < 88% during 6MWTO2 in 73.5% of patients with HYX. CONCLUSIONS In contrast to patients with NOX, patients with HYX and EIH generally benefit from supplemental oxygen by increasing exercise capacity. However, less than one-half of patients reached the threshold of clinically relevant improvements. These oxygen responders were characterized by significantly lower exercise capacity levels. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT00886639; URL: www.clinicaltrials.gov.
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Effect of heart failure reversal treatment as add-on therapy in patients with chronic heart failure: A randomized, open-label study.
Sane, R, Aklujkar, A, Patil, A, Mandole, R
Indian heart journal. 2017;(3):299-304
Abstract
OBJECTIVES The present study was designed to evaluate effect of heart failure reversal therapy (HFRT) using herbal procedure (panchakarma) and allied therapies, as add-on to standard CHF treatment (SCT) in chronic heart failure (CHF) patients. METHODS This open-label, randomized study conducted in CHF patients (aged: 25-65 years, ejection fraction: 30-65%), had 3-phases: 1-week screening, 6-week treatment (randomized [1:1] to HFRT+SCT or SCT-alone) and follow-up (12-week). Twice weekly HFRT (60-75min) consisting of snehana (external oleation), swedana (passive heat therapy), hrudaydhara (concoction dripping treatment) and basti (enema) was administered. Primary endpoints included evaluation of change in metabolic equivalents of task (MET) and peak oxygen uptake (VO2peak) from baseline, at end of 6-week treatment and follow-up at week-18 (non-parametric rank ANCOVA analysis). Safety and quality of life (QoL) was assessed. RESULTS Seventy CHF patients (n=35, each treatment-arm; mean [SD] age: 53.0 [8.6], 80% men) were enrolled in the study. All patients completed treatment phase. Add-on HFRT caused a significant increase in METs (least square mean difference [LSMD], 6-week: 1.536, p=0.0002; 18-week: -1.254, p=0.0089) and VO2peak (LSMD, 6-week: -5.52, p=0.0002; 18-week: -4.517, p=0.0089) as compared with SCT-alone. Results were suggestive of improved functional capacity in patients with HFRT (QoL; Mean [SD] HFRT+SCT vs. SCT-alone; 6-week: -0.44 [0.34] vs. -0.06 [0.25], p<0.0001 and 18-week: -0.53 [0.35] vs. -0.29 [0.26], p=0.0013). Seven treatment-emergent adverse events (mild severity) were reported in HFRT-arm. CONCLUSION Findings of this study highlight therapeutic efficacy of add-on HFRT vs. SCT-alone in CHF patients. The non-invasive HFRT showed no safety concerns.
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High flow nasal cannula versus NCPAP, duration to full oral feeds in preterm infants: a randomised controlled trial.
Glackin, SJ, O'Sullivan, A, George, S, Semberova, J, Miletin, J
Archives of disease in childhood. Fetal and neonatal edition. 2017;(4):F329-F332
Abstract
OBJECTIVE To compare the time taken by preterm infants with evolving chronic lung disease to achieve full oral feeding when supported with humidified high flow nasal cannula (HFNC) or nasal continuous positive airway pressure (NCPAP). DESIGN Single centre randomised controlled trial. SETTING Level III neonatal intensive care unit at the Coombe Women and Infants University Hospital, Dublin, Ireland. PATIENTS Very low birthweight (birth weight <1500 g) infants born before 30 weeks' gestation who were NCPAP-dependent at 32 weeks corrected gestational age were eligible to participate. INTERVENTIONS Enrolled infants were randomised in a 1:1 ratio to receive HFNC or NCPAP. Participants were monitored daily until full oral feeding was established and the baby was off respiratory support. MAIN OUTCOME MEASURES Our primary outcome was the number of days taken to establish full oral feeds (defined as oral intake ≥120 mL/kg/day) from the time of randomisation. We estimated that enrolling 44 subjects (22 in each group) would allow us demonstrate a 7-day difference in our primary outcome with 80% power and α of 5%. RESULTS Forty-four infants were randomised (22 to HFNC vs 22 to NCPAP). The mean time to achieve full oral feeding was not different between the groups (HFNC 36.5 (±18.2) days vs NCPAP 34.1 (±11.2) days, p=0.61). CONCLUSIONS Preterm infants treated with HFNC did not achieve full oral feeding more quickly than infants treated with NCPAP. TRIAL REGISTRATION NUMBER ISRCTN66716753.