scholarly journals FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care

Critical Care ◽  
2018 ◽  
Vol 22 (1) ◽  
Author(s):  
Padmanabhan Ramnarayan ◽  
◽  
Paula Lister ◽  
Troy Dominguez ◽  
Parviz Habibi ◽  
...  
Keyword(s):  
Critical Care ◽  
Positive Airway Pressure ◽  
High Flow Nasal Cannula ◽  
First Line ◽  
Non Invasive ◽  
Pilot Rct ◽  
Group A ◽  
Group B ◽  
Randomised Controlled ◽  
Paediatric Critical Care

Abstract Background Although high-flow nasal cannula therapy (HFNC) has become a popular mode of non-invasive respiratory support (NRS) in critically ill children, there are no randomised controlled trials (RCTs) comparing it with continuous positive airway pressure (CPAP). We performed a pilot RCT to explore the feasibility, and inform the design and conduct, of a future large pragmatic RCT comparing HFNC and CPAP in paediatric critical care. Methods In this multi-centre pilot RCT, eligible patients were recruited to either Group A (step-up NRS) or Group B (step-down NRS). Participants were randomised (1:1) using sealed opaque envelopes to either CPAP or HFNC as their first-line mode of NRS. Consent was sought after randomisation in emergency situations. The primary study outcomes were related to feasibility (number of eligible patients in each group, proportion of eligible patients randomised, consent rate, and measures of adherence to study algorithms). Data were collected on safety and a range of patient outcomes in order to inform the choice of a primary outcome measure for the future RCT. Results Overall, 121/254 eligible patients (47.6%) were randomised (Group A 60%, Group B 44.2%) over a 10-month period (recruitment rate for Group A, 1 patient/site/month; Group B, 2.8 patients/site/month). In Group A, consent was obtained in 29/33 parents/guardians approached (87.9%), while in Group B 84/118 consented (71.2%). Intention-to-treat analysis included 113 patients (HFNC 59, CPAP 54). Most reported adverse events were mild/moderate (HFNC 8/59, CPAP 9/54). More patients switched treatment from HFNC to CPAP (Group A: 7/16, 44%; Group B: 9/43, 21%) than from CPAP to HFNC (Group A: 3/13, 23%; Group B: 5/41, 12%). Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38). HFNC patients experienced fewer ventilator-free days at day 28 (Group A: 19.6 vs. 23.5; Group B: 21.8 vs. 22.2). Conclusions Our pilot trial confirms that, following minor changes to consent procedures and treatment algorithms, it is feasible to conduct a large national RCT of non-invasive respiratory support in the paediatric critical care setting in both step-up and step-down NRS patients. Trial registration clinicaltrials.gov, NCT02612415. Registered on 23 November 2015.

scholarly journals FIRST-line support for assistance in breathing in children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038002 ◽  
Author(s):  
Alvin Richards-Belle ◽  
Peter Davis ◽  
Laura Drikite ◽  
Richard Feltbower ◽  
Richard Grieve ◽  
...  
Keyword(s):  
Critical Care ◽  
Continuous Positive Airway Pressure ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
High Flow ◽  
Respiratory Support ◽  
High Flow Nasal Cannula ◽  
First Line ◽  
Non Invasive ◽  
Paediatric Critical Care

IntroductionEven though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with CPAP) as the first-line mode of support in critically ill children.Methods and analysisWe will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require NRS for an acute illness (step-up RCT) or within 72 hours of extubation following a period of invasive ventilation (step-down RCT). Due to the emergency nature of the treatment, written informed consent will be deferred to after randomisation. Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months). The primary outcome is time to liberation from respiratory support for a continuous period of 48 hours. A total sample size of 600 patients in each RCT will provide 90% power with a type I error rate of 2.5% (one sided) to exclude the prespecified non-inferiority margin of HR of 0.75. Primary analyses will be undertaken separately in each RCT in both the intention-to-treat and per-protocol populations.Ethics and disseminationThis master protocol received favourable ethical opinion from National Health Service East of England—Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences.Trial registration numberISRCTN60048867

scholarly journals Oxygenation failure after cardiac surgery: early re-intubation versus treatment by nasal continuous positive airway pressure (NCPAP) or non-invasive positive pressure ventilation (NPPV)

2016 ◽  
Vol 70 (2) ◽  
Author(s):  
Muhammed Kurt ◽  
Udo Boeken ◽  
Jens Litmathe ◽  
Peter Feindt ◽  
Emmeran Gams
Keyword(s):  
Cardiac Surgery ◽  
Respiratory Failure ◽  
Oxygen Transfer ◽  
Airway Pressure ◽  
Positive Pressure Ventilation ◽  
Positive Airway Pressure ◽  
Positive Pressure ◽  
Non Invasive ◽  
Group A ◽  
Group B

Background: Due to an increasing incidence of respiratory failure after cardiac surgery we wanted to study whether nasal continuous positive airway pressure (NCPAP) may improve pulmonary oxygen transfer and may avoid reintubation after coronary operations. Additionally, we compared this protocol to non-invasive positive pressure ventilation (NPPV). Methods: For a period of 2 years we analyzed all patients that were extubated within 12 hours after coronary surgery, and in whom oxygen transfer (PaO2/FIO2) deteriorated without hypercapnia so that all these patients met predefined criteria for reintubation: group A=immediate reintubation (n=88), group B=NCPAP-treatment (n=173), group C=NPPV(n=18). Results: 25,4% of group B- and 22,2% of group C-patients were also intubated after a period of NCPAP or NPPV. All other patients of groups B and C could be weaned from these devices (B = 34.3 ± 5.9 hours; C = 26.4 ± 4.4 h; p&lt;0.05) and were well oxygenated by face mask at ambient pressure (Ratio PaO2/FIO2: B, 138 ± 13; C, 140 ± 13). In group A we found a higher mortality (7.95%) compared to group B (4.04%) and group C (5.55%). NCPAP-patients suffered more frequently from an impaired sternal wound healing (A = 4.5%, B = 8.6%; p&lt;0.05). Conclusions: We conclude that reintubation after cardiac operations should be avoided since NCPAP and NPPV are safe and effective to improve arterial oxygenation in most patients with non hypercapnic respiratory failure.

scholarly journals Prospective Parallel Randomized, Double-Blind, Double-Dummy Controlled Clinical Trial Comparing Clomiphene Citrate and Metformin as the First-Line Treatment for Ovulation Induction in Nonobese Anovulatory Women with Polycystic Ovary Syndrome

2005 ◽  
Vol 90 (7) ◽  
pp. 4068-4074 ◽  
Author(s):  
Stefano Palomba ◽  
Francesco Orio ◽  
Angela Falbo ◽  
Francesco Manguso ◽  
Tiziana Russo ◽  
...  
Keyword(s):  
Polycystic Ovary ◽  
Clomiphene Citrate ◽  
Controlled Clinical Trial ◽  
Line Treatment ◽  
First Line ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Group A ◽  
Group B ◽  
First Line Treatment

Abstract Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University “Magna Graecia” of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A (n = 45) and B (n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P &lt; 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.

scholarly journals Oral versus intravenous maternal hydration in isolated third trimester oligohydramnios

2020 ◽  
Vol 8 (10) ◽  
pp. 3449
Author(s):  
Humaira Zafar ◽  
Mubashra Naz ◽  
Umber Fatima ◽  
Uzma Shahzad ◽  
Anees Fatima ◽  
...  
Keyword(s):  
Amniotic Fluid ◽  
P Value ◽  
Amniotic Fluid Index ◽  
Oral Hydration ◽  
Non Invasive ◽  
Invasive Method ◽  
Intravenous Hydration ◽  
Group A ◽  
Group B ◽  
Hydration Therapy

Background: To study the effect of oral and intravenous maternal hydration in patients with isolated oligohydramnios in terms of mean change in amniotic fluid.Methods: A total number of 38 patients included in the study which fulfill the selection criteria.  Patients were randomly divided in two groups. Amniotic fluid index (AFI) of all patients was measured before the hydration therapy according to the method of Phelan et al.  In maternal oral hydration (Group A), every patient was instructed to drink two liters of water over two hours daily for 1 week. In intravenous hydration (Group B), every woman infused two liters of 0.9% normal saline in two hour daily for 1 week. After 48 hours and 1 week of oral and intravenous hydration, the AFI was reassessed by the same observer. Patients were monitored closely for sign and symptoms of fluid overload. Data was stratified for mean difference in improvement in amniotic fluid index.Results: After oral hydration therapy AFI was 5.926±0.4593 after 48 hours and 8.286±0.6000 after 7 days in Group A. In Group B AFI was 5.784±0.4622 after 48 hours and 7.868±0.2810 after 7 days of intravenous hydration. P value after 48 hours is 0.348 and p=0.014 after 7 days means oral hydration therapy significantly increase amniotic fluid index.Conclusions: Oral maternal hydration significantly increase the amniotic fluid index in patients with isolated oligohydramnios. It is simple, safe and non-invasive method.

scholarly journals A randomised controlled trial on roles of prostaglandin E1 nebulization among patients undergoing one lung ventilation

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Pengyi Li ◽  
Lianbing Gu ◽  
Jing Tan ◽  
Zhenghuan Song ◽  
Qingming Bian ◽  
...  
Keyword(s):  
Prostaglandin E1 ◽  
Controlled Trial ◽  
Lung Ventilation ◽  
Inflammatory Factors ◽  
Pulmonary Shunt ◽  
One Lung Ventilation ◽  
Reference Concentration ◽  
Group A ◽  
Group B ◽  
Randomised Controlled

Abstract Background Prostaglandin E1 (PGE1) has been reported to maintain adequate oxygenation among patients under 60% FiO2 one-lung ventilation (OLV). This research aimed to explore whether PGE1 is safe in pulmonary shunt and oxygenation under 40% FiO2 OLV and provide a reference concentration of PGE1. Methods Totally 90 esophageal cancer patients treated with thoracotomy were enrolled in this study, randomly divided into three groups (n = 30/group): Group A (60% FiO2 and 0.1 µg/kg PGE1), Group B (40% FiO2 and 0.1 µg/kg PGE1), and Group C (40% FiO2, 0.2 µg/kg PGE1). Primary outcomes were oxygenation and pulmonary shunt during OLV. Secondary outcomes included oxidative stress after OLV. Results During OLV, patients in Group C and B had lower levels of PaO2, SaO2, SpO2, MAP, and Qs/Qt than those in Group A (P < 0.05). At T2 (OLV 10 min), patients in Group C and B exhibited a lower level of PaO2/FiO2 than those in Group A, without any statistical difference at other time points. The IL-6 levels of patients in different groups were different at T8 (F = 3.431, P = 0.038), with IL-6 in Group C being lower than that in Group B and A. MDA levels among the three groups differed at T5 (F = 4.692, P = 0.012) and T7 (F = 5.906, P = 0.004), with the MDA level of Group C being lower than that of Group B and A at T5, and the MDA level of Group C and B being lower than that of Group A at T7. In terms of TNF-α level, patients in Group C had a lower level than those in Group B and A at T8 (F = 3.598, P = 0.033). Compared with patients who did not use PGE1, patients in Group C had comparable complications and lung infection scores. Conclusion The concentration of FiO2 could be reduced from 60 to 40% to maintain oxygenation. 40% FiO2 + 0.2 µg/kg PGE1 is recommended as a better combination on account of its effects on the inflammatory factors. Trial registration: Chictr.org.cn identifier: ChiCTR1800018288, 09/09/2018.

scholarly journals Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

2021 ◽  
Author(s):  
Waqar M. Naqvi
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Well Being ◽  
Likert Scale ◽  
Control Group ◽  
Group A ◽  
Measuring Scale ◽  
Group B ◽  
Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

scholarly journals LETROZOLE WITH OR WITHOUT GONADOTROPIN AS A FIRST-LINE OVULATION INDUCTION IN ANOVULATORY INFERTILE WOMEN DUE TO POLYCYSTIC OVARY SYNDROME

2018 ◽  
Vol 11 (8) ◽  
pp. 129
Author(s):  
Fadia J Alizzi
Keyword(s):  
Pregnancy Rate ◽  
Ovulation Induction ◽  
Polycystic Ovary ◽  
Endometrial Thickness ◽  
Ovulation Rate ◽  
First Line ◽  
Cycle Number ◽  
Group A ◽  
Group B ◽  
Ovarian Syndrome

Objectives: The objective is to evaluate the clinical outcome of using letrozole alone or with gonadotropin as first-line ovulation induction in anovulatory infertile polycystic ovary women. Methods: A prospective single-arm study. 80 infertile polycystic ovarian syndrome (PCOS) women had been recruited between January and October 2017. Letrozole on day 2–3 of the cycle was given. The women are sorted into two groups according to the size of the dominant follicle on day 7 or 8, Group A (letrozole only group) and Group B (letrozole plus gonadotropin).Results: In our study, the overall pregnancy rate was (67.5%) and ovulation rate was 91.3%. The ovulation rate was significantly higher in Subgroup A than B (97.9% vs. 81.3%). Pregnancy rate was higher in Subgroup A (72.9% vs. 59.4%), but it was statistically not significant. The number of follicles was significantly higher in Subgroup B. Endometrial thickness, miscarriages, ovarian hyperstimulation syndrome, and multiple pregnancies were not statistically significant. Lower cycle number independently and significantly predict clinical pregnancy, while body mass index has a modest effect.Conclusions: Letrozole alone or in combination with gonadotropin as a first-line treatment in PCOS may be reasonable since this approach may improve the success rate and minimize the overall costs and risks. 

Gallium scans in the evaluation of residual masses after chemotherapy for seminoma.

1995 ◽  
Vol 13 (11) ◽  
pp. 2784-2788 ◽  
Author(s):  
G P Warren ◽  
L H Einhorn
Keyword(s):  
False Negative ◽  
Fibrous Tissue ◽  
Salvage Chemotherapy ◽  
First Line ◽  
Chemotherapy Group ◽  
Computed Tomographic ◽  
Group A ◽  
Residual Masses ◽  
Group B

PURPOSE To assess the ability of gallium scans to determine whether residual masses consist of viable tumor or necrotic fibrous tissue after chemotherapy for seminoma. PATIENTS AND METHODS Thirty-two patients were enrolled and 27 were assessable. Patients receiving first-line or salvage chemotherapy had gallium scans performed during their first and last scheduled course of chemotherapy and results were compared with restaging computed tomographic (CT) scans and subsequent clinical outcome. RESULTS Of 27 assessable patients, 22 received first-line chemotherapy (group A) and five salvage chemotherapy (group B). Eight patients were not gallium-avid before chemotherapy despite obvious clinical and radiographic evidence of metastatic seminoma. Eighteen of 19 gallium-positive patients had a persistent mass postchemotherapy on abdominal CT. Of 16 patients in group A whose tumors were gallium-avid, all 16 had normalized gallium scans after chemotherapy. However, two of these 16 patients recurred in their original disease site. In group B, there were three patients with gallium-avid tumors and all three had normalized scans postchemotherapy. Two patients who were not gallium-avid (one each in group A and B) also developed recurrent disease. Twenty-four of 27 patients are alive with no evidence of active disease at a median follow-up time of 18 months, including 20 with more than 1 year of follow-up data. CONCLUSION Eight of 27 patients had false-negative gallium scans at the time of diagnosis. All nineteen gallium scans that were initially positive reverted to normal after chemotherapy. Two of 19 patients' follow-up gallium scans were false-negative. We therefore feel that gallium scans have minimal value in the prechemotherapy or postchemotherapy evaluation of metastatic seminoma.

scholarly journals Outcome of Pushback Stenting and ESWL Versus in Situ ESWL for Upper Ureteric Stone -A Comparative Study

KYAMC Journal ◽  
2017 ◽  
Vol 8 (1) ◽  
pp. 4-9
Author(s):  
Md Mostafizur Rahman ◽  
Maruf Ahmed ◽  
Md Rokonuzzaman Khan ◽  
Md Shamim Hossain ◽  
Khan Nuzrul Islam ◽  
...  
Keyword(s):  
Urinary Calculi ◽  
Urinary Stones ◽  
Ureteric Stone ◽  
Medical College ◽  
Non Invasive ◽  
Quasi Experimental ◽  
Group A ◽  
Urological Disorders ◽  
Group B

Background: Urolithiasis is one of the most prevalent urological disorders and the prevalence of urinary stones has increased world wide1. The management of urinary calculi was revolutionized by the introduction of extracorporeal shockwave lithotripsy (ESWL) in 1980 and the first successful ESWL treatment was accomplished in Germany by Dr. Christian Chaussy using a Dornier HM1 lithotripter. ESWL is a safe, effective and non-invasive method2.Purpose: To observe the outcome of pushback stenting and ESWL versus in situ ESWL for upper ureteric stone.Materials and methods: It was a quasi-experimental study. The study was under went in the department of urology, Dhaka Medical College and Hospital, between July'2012 to June'2014. Total 60 patients of single upper ureteric stone who satisfy inclusion and exclusion criteria were enrolled in this study. Selected patients were dived into two groups, group A and group B. Group-A for pushback stenting and ESWL and group-B for in situ ESWL. Results were compared in terms of clearance rates, number of shock waves, sessions, incidence of complications and failure rate.Results: Failure of ESWL was significantly higher in Group B (23.33%) than Group A (10%). These results were statistically significant.Conclusion: Pushback stenting and ESWL is better than in situ ESWL for upper ureteric stone.KYAMC Journal Vol. 8, No.-1, Jul 2017, Page 4-9

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