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1.
Fluid restriction in the management of transient tachypnea of the newborn.
Gupta, N, Bruschettini, M, Chawla, D
The Cochrane database of systematic reviews. 2021;(2):CD011466
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Abstract
BACKGROUND Transient tachypnea of the newborn (TTN) is caused by delayed clearance of lung fluid at birth. TTN typically appears within the first two hours of life in term and late preterm neonates and is characterized by tachypnea and signs of respiratory distress. Although it is usually a self-limited condition, admission to a neonatal unit is frequently required for monitoring and providing respiratory support. Restricting intake of fluids administered to these infants in the first days of life might improve clearance of lung liquid, thus reducing the effort required to breathe, improving respiratory distress, and potentially reducing the duration of tachypnea. OBJECTIVES To evaluate the efficacy and safety of restricted fluid therapy as compared to standard fluid therapy in decreasing the duration of oxygen administration and the need for noninvasive or invasive ventilation among neonates with TTN. SEARCH METHODS We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 12), in the Cochrane Library; Ovid MEDLINE and electronic ahead of print publications, in-process & other non-indexed citations, Daily and Versions(R); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), on December 6, 2019. We also searched clinical trial databases and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. SELECTION CRITERIA We included randomized controlled trials (RCTs), quasi-RCTs, and cluster trials on fluid restriction in term and preterm neonates with the diagnosis of TTN or delayed adaptation during the first week after birth. DATA COLLECTION AND ANALYSIS For each of the included trials, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy, need for continuous positive airway pressure [CPAP], need for mechanical ventilation, duration of mechanical ventilation) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcome considered in this review was the duration of supplemental oxygen therapy in hours or days. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS Four trials enrolling 317 infants met the inclusion criteria. Three trials enrolled late preterm and term infants with TTN, and the fourth trial enrolled only term infants with TTN. Infants were on various methods of respiratory support at the time of enrollment including room air, oxygen, or nasal CPAP. Infants in the fluid-restricted group received 15 to 20 mL/kg/d less fluid than those in the control group for varying durations after enrollment. Two studies had high risk of selection bias, and three out of four had high risk of performance bias. Only one study had low risk of detection bias, with two at high risk and one at unclear risk. The certainty of evidence for all outcomes was very low due to imprecision of estimates and unclear risk of bias. Two trials reported the primary duration of supplemental oxygen therapy. We are uncertain whether fluid restriction decreases or increases the duration of supplemental oxygen therapy (mean difference [MD] -12.95 hours, 95% confidence interval [CI] -32.82 to 6.92; I² = 98%; 172 infants). Similarly, there is uncertainty for various secondary outcomes including incidence of hypernatremia (serum sodium > 145 mEq/L, risk ratio [RR] 4.0, 95% CI 0.46 to 34.54; test of heterogeneity not applicable; 1 trial, 100 infants), hypoglycemia (blood glucose < 40 mg/dL, RR 1.0, 95% CI 0.15 to 6.82; test of heterogeneity not applicable; 2 trials, 164 infants), endotracheal ventilation (RR 0.73, 95% CI 0.24 to 2.23; I² = 0%; 3 trials, 242 infants), need for noninvasive ventilation (RR 0.40, 95% CI 0.14 to 1.17; test of heterogeneity not applicable; 2 trials, 150 infants), length of hospital stay (MD -0.92 days, 95% CI -1.53 to -0.31; test of heterogeneity not applicable; 1 trial, 80 infants), and cumulative weight loss at 72 hours of age (%) (MD 0.24, 95% CI -1.60 to 2.08; I² = 89%; 2 trials, 156 infants). We did not identify any ongoing trials; however, one trial is awaiting classification. AUTHORS' CONCLUSIONS We found limited evidence to establish the benefits and harms of fluid restriction in the management of TTN. Given the very low certainty of available evidence, it is impossible to determine whether fluid restriction is safe or effective for management of TTN. However, given the simplicity of the intervention, a well-designed trial is justified.
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2.
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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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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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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Efficacy of High-Flow Nasal Cannula vs Standard Oxygen Therapy or Nasal Continuous Positive Airway Pressure in Children with Respiratory Distress: A Meta-Analysis.
Luo, J, Duke, T, Chisti, MJ, Kepreotes, E, Kalinowski, V, Li, J
The Journal of pediatrics. 2019;:199-208.e8
Abstract
OBJECTIVES To evaluate the efficacy of high-flow nasal cannula (HFNC) oxygen therapy in providing respiratory support of children with acute lower respiratory infection (ALRI), hypoxemia, and respiratory distress. STUDY DESIGN We performed a meta-analysis of randomized controlled trials that compared HFNC and standard flow oxygen therapy or nasal continuous positive airway pressure (nCPAP) and reported treatment failure as an outcome. Data were synthesized using Mann-Whitney U test. RESULTS Compared with standard oxygen therapy, HFNC significantly reduced treatment failure (risk ratio [RR] 0.49, 95% CI 0.40-0.60, P < .001) in children with mild hypoxemia (arterial pulse oximetry [SpO2] >90% on room air). HFNC had an increased risk of treatment failure compared with nCPAP in infants age 1-6 months with severe hypoxemia (SpO2 <90% on room air or SpO2 >90% on supplemental oxygen) (RR 1.77, 95% CI 1.17-2.67, P = .007). No significant differences were found in intubation rates and mortality between HFNC and standard oxygen therapy or nCPAP. HFNC had a lower risk of nasal trauma compared with nCPAP (RR 0.35, 95% CI 0.16-0.77, P = .009). CONCLUSIONS Among children <5 years of age with ALRI, respiratory distress, and mild hypoxemia, HFNC reduced the risk of treatment failure when compared with standard oxygen therapy. However, nCPAP was associated with a lower risk of treatment failure than HFNC in infants age 1-6 months with ALRI, moderate-to-severe respiratory distress, and severe hypoxemia. No differences were found in intubation and mortality between HFNC and standard oxygen therapy or nCPAP.
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7.
Current Recommendations and Practice of Oxygen Therapy in Preterm Infants.
Tarnow-Mordi, W, Kirby, A
Clinics in perinatology. 2019;(3):621-636
Abstract
This narrative review identified 23 publications in 2011 to 2019 discussing randomized trials of oxygen saturation targets of 85% to 89% versus 91% to 95% in infants below 28 weeks' gestation. Of 18 commentaries or consensus statements, 17 recommended saturation targets above 89%. Five systematic reviews reported that the 85% to 89% target increased mortality but not the composite of death or disability. The evidence for increased mortality was assessed as of "high", "moderate," or "low," quality, reflecting substantial differences in interpreting the GRADE guidelines. Systematic reviews and guidelines without biostatisticians or epidemiologists as co-authors should be considered potentially problematic.
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Meta-analysis of Oxygenation Saturation Targeting Trials: Do Infant Subgroups Matter?
Askie, LM
Clinics in perinatology. 2019;(3):579-591
Abstract
Participant data from approximately 5000 infants have been meta-analyzed to guide oxygen saturation policy for extremely preterm infants. The Neonatal Oxygenation Prospective Meta-analysis showed that targeting a higher oxygen saturation range compared with a lower range resulted in decreased death and necrotizing enterocolitis and no difference in major disability but increased treated retinopathy of prematurity (ROP) and supplemental oxygen use at 36 weeks' postmenstrual age. The 91% to 95% range can be recommended for all extremely preterm infants from birth but should be accompanied by stringent surveillance for the prevention and early treatment of ROP.
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Oxygen Toxicity in the Neonate: Thinking Beyond the Balance.
Tipple, TE, Ambalavanan, N
Clinics in perinatology. 2019;(3):435-447
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Abstract
Fetal development occurs in a relatively hypoxemic environment, and birth represents significant oxidative stress. Premature infants are disadvantaged by a lack of maternal antioxidant transfer and impaired endogenous antioxidant responses. O2 metabolism is essential for life and its biochemical reactions are dynamic, compartmentalized, and difficult to characterize in vivo. There is a growing appreciation for the role of reactive oxygen species in nonpathologic processes, including regulation of cell signaling and mitochondrial function. There are several gaps in the knowledge about the role of reactive oxygen species in normal development and how oxidative stress alters normal signaling and subsequent development.
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Oxygen Saturation and Retinopathy of Prematurity.
Higgins, RD
Clinics in perinatology. 2019;(3):593-599
Abstract
Retinopathy of prematurity (ROP) is a serious disease affecting premature infants. Rates of ROP increase with decreasing gestational age. Duration of oxygen exposure is correlated with ROP. Many studies evaluating oxygen have been performed to assess impact on ROP. This article describes recent findings for oxygen saturation target studies and suggests area of future study for ROP.