scholarly journals Comparison of Fatty Meal, Drotaverine and Hyoscine for Duodenal Anti-motility and Cannulation During ERCP- A Randomised Controlled Trial

2020 ◽  
Author(s):  
S Vadivel Kumaran ◽  
Rajesh Nanda Amarnath ◽  
Mohammed Ali ◽  
T Pugazhendhi
Keyword(s):  
Statistical Analysis ◽  
Adverse Effects ◽  
Pulse Rate ◽  
Tamil Nadu ◽  
Controlled Trial ◽  
P Value ◽  
Fatty Meal ◽  
Butyl Bromide ◽  
Suitable Alternative ◽  
Drotaverine Hydrochloride

Introduction: Endoscopic Retrograde Cholangiopancreatography (ERCP) is a technically demanding procedure that requires considerable amount of training to be performed safely. Successful cannulation of the ducts depends on the expertise of the endoscopist. Conventionally, cannulation is facilitated with the help of smooth muscle relaxants like Hyoscine-N-butyl bromide or Drotaverine which impair duodenal contractions and facilitate sphincter of oddi relaxation. Aim: To compare the effect of Fatty meal versus Drotaverine hydrochloride versus Hyoscine-N-butyl bromide on duodenal contraction rate, ease of identification of the papillary orifice, time for cannulation, and adverse effects of agents used on haemodynamic parameters. Materials and Methods: The study was conducted at Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai,Tamil Nadu, India, where 60 patients admitted for ERCP with normal appearing ampulla, were taken-up for the study. Patients were subjected randomly into the three groups viz., Hyoscine group, Drotaverine group and Fatty meal group. In Fatty meal group, 200 mL of semi skimmed milk (1.7% fat) was given orally one hour prior to the procedure to allow for gastric emptying. A 20 mg of intravenous Hyoscine-N-butyl bromide and 40 mg of intravenous Drotaverine hydrochloride were administered 15 minutes before procedure in Hyoscine and Drotaverine group, respectively. Statistical analysis was done by Chi-square test and Analysis of Variance (ANOVA) test and using Statistical Package for the Social Sciences (SPSS) 16.0 version software. A p-value <0.05 was considered significant. Results: The difference in duodenal motility, cannulation time and success of the procedure did not show a statistically significant p-value between the three groups. The identification of ampulla was easy with the fatty meal group. The statistical analysis for intraprocedural change in pulse rate and Blood Pressure (BP) variation showed a significant p-value for Hyoscine group compared to the other two groups. The change in pulse rate for Hyoscine vs. Drotaverine vs. Fatty meal group during the procedure was 51.5±12.8 vs. 24.2±8.4 vs. 24.4±8.8 per minute, respectively. The variation in BP during the procedure was 18.3/15.7±7.7/9.0 mmHg vs. 9.0/8.7±5.7/5.6 mmHg vs. 10.4/8.6±4.6/3.3 mmHg for Hyoscine vs. Drotaverine vs. Fatty meal group respectively. Conclusion: Fatty meal is not inferior to the conventionally used Hyoscine-N-butyl bromide or Drotaverine for its anti-motility effect on the duodenum during ERCP. The cannulation time is no different within the groups. Fatty meal, the action of which is physiological may be used as a suitable alternative to antispasmodic pharmacological agents which have potential adverse effects.

scholarly journals Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mariana Bichuette Cartuliares ◽  
Helene Skjøt-Arkil ◽  
Flemming Schønning Rosenvinge ◽  
Christian Backer Mogensen ◽  
Thor Aage Skovsted ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Adverse Effects ◽  
Lower Respiratory Tract ◽  
Controlled Trial ◽  
Sputum Sample ◽  
Statistical Analysis Plan ◽  
Sputum Induction ◽  
Randomized Controlled

Abstract Background Targeted antimicrobial treatment is essential to avoid unnecessary use of broad-spectrum antibiotics and antimicrobial resistance. Targeted treatment relies on a precise microbiological diagnosis — in pneumonia, this poses a challenge as the usefulness of Gram stains and cultures is highly dependent on the quality of the sputum sample. This study aims to examine adverse effects and quality of sputum samples obtained by expiratory techniques (forced expiratory technique and sputum induction) compared with tracheal suction. The hypothesis is that expiratory techniques are non-inferior to tracheal suction in obtaining samples from the lower respiratory tract. This statistical analysis plan (SAP) describes the study design, method, and data analysis of the trial to increase transparency, avoid reporting bias or data-driven analysis and increase the study’s reproducibility. Method The design is a pragmatic, non-inferiority, parallel-arm randomized controlled trial including 280 patients admitted with suspected lower respiratory infection to two emergency departments. Patients are randomized to a usual care group, where sputum samples are collected by tracheal suction or to an intervention group where sputum samples are collected by forced expiratory technique and sputum induction. The statistical analysis will follow an intention-to-treat protocol. This SAP is developed and submitted before the end of recruitment, database closure, and statistical analyses. Discussion The results of this study will provide valuable knowledge to clinical practice by comparing adverse effects and sputum sample quality associated with different sample methods. Trial registration Clinicaltrials.gov, NCT04595526. Submitted on October 19, 2020

scholarly journals Role and Adverse Effects of Premedication for Reducing Pain and Discomfort during Fiberoptic Nasal Pharyngoscopy and Laryngoscopy

2020 ◽  
Vol 8 (1) ◽  
pp. 55-59
Author(s):  
Anup Acharya ◽  
Madan Mohan Singh ◽  
Bhuwan Raj Pandey ◽  
Shiv Bhushan Pandit ◽  
Suman Bartaula
Keyword(s):  
Adverse Effects ◽  
Local Anesthetic ◽  
Controlled Trial ◽  
Visual Analogue Score ◽  
Burning Sensation ◽  
Nasal Endoscopy ◽  
P Value ◽  
Common Procedure ◽  
Randomized Controlled ◽  
Lidocaine Spray

INTRODUCTION: Fiberoptic nasal endoscopy is a common procedure. Pretreatment with many drugs has been tried to decrease discomfort and pain related to the procedure. It was our effort to study whether they are effective in reducing pain and discomfort of the procedure. MATERIAL AND METHODS: It was a four-armed triple blind randomized controlled trial. Block randomization was done. Four arms were pretreated with placebo, decongestant spray, local anesthetic spray, and combination of decongestant and local anesthetic spray. Discomfort of pretreatment, discomfort of the procedure, pain due to procedure, ease of procedure and adverse effects were recorded by visual analogue score and analyzed by non-parametric tests. P value less than 0.05 was considered statistically significant. RESULTS: There were 40 participants in each wing making a total of 160. There were 79 males and 89 females. Discomfort of pretreatment was significantly higher is groups treated with lidocaine spray alone or in combination (p<0.001). Discomfort due to procedure was lowest in group pretreated with placebo (p=0.009) and pain was comparable throughout the groups (0.15).The procedure of nasal endoscopy was easiest in group pretreated with decongestant spray (p=0.02). Adverse effect was highest in form of burning sensation and pain in groups treated with lidocaine (p<0.001). CONCLUSION: Lidocaine spray caused a lot of discomfort in form of pain and burning sensation and was not able to decrease pain or discomfort, alone or in combination with decongestant, related to fiberoptic nasal endoscopy. Decongestant, however, made the procedure easier.

scholarly journals A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Elexis C. Kierstead ◽  
Emily Harvey ◽  
Denisse Sanchez ◽  
Kimberly Horn ◽  
Lorien C. Abroms ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Self Efficacy ◽  
Text Messaging ◽  
Controlled Trial ◽  
P Value ◽  
People Living With Hiv ◽  
Randomized Controlled ◽  
Living With Hiv ◽  
Pilot Randomized Controlled Trial

Abstract Objective Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. We conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model. We compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging. Results The primary outcome was smoking cessation. Secondary outcomes included cigarettes per day (CPD), exhaled carbon monoxide (CO), and cessation self-efficacy. A total of 25 participants were enrolled (TI:11, SOC:14), and 2 were lost to follow-up. There were no significant differences in quit rates between study groups. However, there was a significantly greater decrease in CPD in the TI versus SOC (13.5 vs. 0.0, p-value:0.036). Additionally, self-efficacy increased in both groups (TI p-value:0.012, SOC p-value:0.049) and CO decreased in both groups (TI p-value: < 0.001, SOC p-value:0.049). This intervention shows promise to support smoking cessation among PLWH. A larger study is needed to fully evaluate the efficacy of this approach. Clinical trial: Trial Registration: Retrospectively registered (10/20/2020) NCT04594109.

scholarly journals Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e041673
Author(s):  
Nicole E M Jaspers ◽  
Frank L J Visseren ◽  
Yolanda van der Graaf ◽  
Yvo M Smulders ◽  
Olga C Damman ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Life Expectancy ◽  
Statin Therapy ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
P Value ◽  
Cvd Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

scholarly journals Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042101
Author(s):  
Saba Aijaz ◽  
Sana Sheikh ◽  
Asad Pathan
Keyword(s):  
Randomised Controlled Trial ◽  
Radial Artery ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Ease Of Use ◽  
P Value ◽  
Radial Compression ◽  
Open Label ◽  
Scientific Publications ◽  
Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

scholarly journals Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 463
Author(s):  
Mar Gomis-Pastor ◽  
Sonia Mirabet Perez ◽  
Eulalia Roig Minguell ◽  
Vicenç Brossa Loidi ◽  
Laura Lopez Lopez ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Patient Experience ◽  
Mobile Application ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
P Value ◽  
Adherence Score

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot)

2016 ◽  
Vol 12 (2) ◽  
pp. 211-215
Author(s):  
Verónica V Olavarría ◽  
Hisatomi Arima ◽  
Craig S Anderson ◽  
Alejandro Brunser ◽  
Paula Muñoz-Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Pilot Study ◽  
Acute Ischemic Stroke ◽  
Transcranial Doppler ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Anterior Circulation

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

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