Utility of nasal application of lignocaine gel using cotton tip swab versus squirting with slip-tip syringe for transnasal fibreoptic bronchoscopy: a pilot randomised controlled trial

2021 ◽  
pp. postgradmedj-2020-139626
Author(s):  
Animesh Ray ◽  
Sagnik Biswas ◽  
Mouna B Manjunath ◽  
Ved Prakash Meena ◽  
Prayas Sethi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Fibreoptic Bronchoscopy ◽  
Nasal Passage ◽  
Cotton Swab ◽  
Pilot Randomised Controlled Trial ◽  
Significant Difference ◽  
Nasal Application ◽  
The Mean ◽  
Randomised Controlled ◽  
Nasal Anaesthesia

BackgroundDuring flexible fibreoptic bronchoscopy through the nasal route, anaesthesia of the nasal passage is achieved by lignocaine gel application by a slip-tip syringe or with the help of a cotton tip swab. No studies in existing literature have compared the two techniques in terms of efficacy.Methods137 consecutive patients undergoing bronchoalveolar lavage (BAL) were recruited over a 2-year period. The patients underwent BAL after nasal anaesthesia—either by slip-tip syringe or by cotton tip swab smeared with 2% lignocaine gel. Patients were monitored for intraprocedural epistaxis, discomfort and improvement in operator visibility of nasal passage.Results67 patients were randomised to cotton swab and 70 patients to the gel instillation group. There were no significant differences in terms of epistaxis, 29.9% in the cotton tip swab (95% CI 19.3% to 42.3%) versus 24.3% in the gel instillation group (95% CI 14.8% to 36%) or detection of nasal blocks, 7.5% in the cotton tip swab (95% CI 2.5% to 16.6%) versus 10% in the gel instillation group (95% CI 4.1% to 19.5%) in the two groups, although a significant difference was there in terms of visibility, 73.1% in the cotton tip swab (95% CI 60.9% to 83.2%) versus 42.9% in the gel instillation group (95% CI 31.1% to 55.3%). There was no difference in the mean pain score across the two groups either during the procedure or 1 hour after it. A short systematic review of existing literature on the topic has been provided for comparison.ConclusionApplication of 2% lignocaine gel by slip-tip syringe and cotton tip swab are equivalent in terms of observed and narrated pain experienced by patients, frequency of epistaxis and nasal blocks. Vision was better preserved in the cotton tip swab group.

Acupuncture Combined with An Antidepressant for Patients with Depression in Hospital: A Pragmatic Randomised Controlled Trial

2014 ◽  
Vol 32 (4) ◽  
pp. 308-312 ◽  
Author(s):  
Tianjun Wang ◽  
Lingling Wang ◽  
Wenjian Tao ◽  
Li Chen
Keyword(s):  
Randomised Controlled Trial ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Groups ◽  
Significant Difference ◽  
The Mean ◽  
Randomised Controlled ◽  
And Control ◽  
Pragmatic Randomised Controlled Trial

Objective To assess the effectiveness of acupuncture combined with selective serotonin reuptake inhibitors (SSRIs) for patients with depression in hospital using a pragmatic randomised controlled trial. Methods 76 patients with depression were randomly divided into two groups (randomisation ratio 2:1 for treatment and control groups (CGs), respectively) and 71 patients completed the study. The 45 patients in the treatment group (TG) underwent acupuncture and received an SSRI and the 26 patients in the CG received an SSRI only. The 17-item Hamilton Depression Rating Scale (HDRS-17) was used to quantitatively assess patients after 1, 2, 4 and 6 weeks of treatment. Results The mean (SD) baseline total HDRS scores were 22.2 (0.60) and 22.1 (0.33) in the TG and CG, respectively. After the first week of treatment the HDRS score for the TG was reduced to 15.6 (0.81), significantly different from the score of 18.3 (0.55) for the CG, p<0.05. This significant difference was maintained to the end of the 6-week treatment period, when HDRS scores had fallen to 6.3 (0.49) and 8.2 (0.35) for the TG and CG, respectively. Conclusions Acupuncture combined with an SSRI showed a statistically significant benefit for patients with depression in hospital over the 6-week period compared with SSRIs alone. This reduction in symptoms started in the first week and continued throughout the 6 weeks of treatment.

scholarly journals A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ahmad Farouk Musa ◽  
Jeswant Dillon ◽  
Mohamed Ezani Md Taib ◽  
Alwi Mohamed Yunus ◽  
Abdul Rais Sanusi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Control Group ◽  
Inflammatory Agent ◽  
Significant Difference ◽  
The Mean ◽  
Anti Inflammatory ◽  
Randomised Controlled

Abstract Introduction Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. Aims The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. Methods This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. Results Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). Conclusion A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037

scholarly journals Acceptability and Feasibility of a 13-Week Pilot Randomised Controlled Trial Testing the Effects of Incremental Doses of Beetroot Juice in Overweight and Obese Older Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 769
Author(s):  
Abrar M Babateen ◽  
Oliver M Shannon ◽  
Gerard M O’Brien ◽  
Edward Okello ◽  
Anmar A Khan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Beetroot Juice ◽  
Obese Adults ◽  
Pilot Randomised Controlled Trial ◽  
Brain Functions ◽  
Linear Relationships ◽  
Trial Testing ◽  
Pilot Rct ◽  
Randomised Controlled

Nitrate-rich food can increase nitric oxide production and improve vascular and brain functions. This study examines the feasibility of a randomised controlled trial (RCT) testing the effects of prolonged consumption of different doses of dietary nitrate (NO3-) in the form of beetroot juice (BJ) in overweight and obese older participants. A single-blind, four-arm parallel pilot RCT was conducted in 62 overweight and obese (30.4 ± 4 kg/m2) older participants (mean ± standard deviation (SD), 66 ± 4 years). Participants were randomized to: (1) high-NO3- (HN: 2 × 70 mL BJ/day) (2) medium-NO3- (MN: 70 mL BJ/day), (3) low-NO3- (LN: 70 mL BJ on alternate days) or (4) Placebo (PL: 70 mL of NO3--depleted BJ on alternate days), for 13 weeks. Compliance was checked by a daily log of consumed BJ, NO3- intake, and by measuring NO3- and NO2- concentrations in plasma, saliva, and urine samples. Fifty participants completed the study. Self-reported compliance to the interventions was >90%. There were significant positive linear relationships between NO3- dose and the increase in plasma and urinary NO3- concentration (R2 = 0.71, P < 0.001 and R2 = 0.46 P < 0.001, respectively), but relationships between NO3- dose and changes in salivary NO3- and NO2- were non-linear (R2 = 0.35, P = 0.002 and R2 = 0.23, P = 0.007, respectively). The results confirm the feasibility of prolonged BJ supplementation in older overweight and obese adults.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1042
Author(s):  
Nicholas Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

Low‐cost local food supplements could improve maternal and birth outcomes in Indonesia: A pilot randomised controlled trial

2021 ◽  
Vol 46 (3) ◽  
pp. 321-331
Author(s):  
Kun A. Susiloretni ◽  
Dyah Nur Subandriani ◽  
Elisa Ulfiana ◽  
Sunarto Sunarto ◽  
Trina Astuti ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Birth Outcomes ◽  
Local Food ◽  
Low Cost ◽  
Controlled Trial ◽  
Food Supplements ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled
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