Is there an optimal place to hold the endotracheal tube during direct laryngoscopy? Protocol for a Randomised Controlled Trial

Abstract Background: Laryngoscopic endotracheal intubation (LEI) is a widely performed lifesaving technique. There are evidence and guidelines to help decide the optimal sized endotracheal tube (ET), laryngoscope, depth of insertion, and patient position for successful endotracheal intubation. We hypothesize that after glottic visualization, the point at which the ET is held will affect the time, ease, and success of the technique due to a difference in visualization and torque. We aim to compare two sites of holding the ET after optimal laryngeal-inlet visualization: time to intubation, rate of success of first pass intubation, intubation difficulty and complications.Methods: Supervised intubations on ASA 1-2 patients (>18 years) posted for surgery under general anesthesia performed by anesthesia trainees (experience <18 months) will be included. Patients with an anticipated difficult airway or unanticipated difficulty - CL grade > three or requiring the use of airway adjuncts will be excluded. A computer-generated numbers list will randomize patients; allocation concealed with opaque sealed envelopes. ET marked at the selected site will be handed to the intubator by the theatre-technician once she/he confirms the optimum laryngoscopic view. The entire procedure will be video recorded. Two blinded assessors will independently review the videos to document the time to intubation (TTI defined as the time from holding the ET to the removal of laryngoscope from the mouth after successful intubation) and intubation difficulty score. Postoperative sore throat and hoarseness will be recorded.Sample size: 54 experienced anesthetists were video-recorded during intubating. The site of holding ET and TTI were analyzed. The mean site was 3 SD 2.5 cm from the tip, yielding two sites for the study- 19 cm (Gr 1) and 24 cm (Gr 2). To detect a 20% difference in intubation time between groups, the confidence of 95%, and power 85%, we will need 298 patients: 180 per group after accounting for data loss.Discussion: This will be the first study to assess whether holding the tube at a particular site has any impact on the ease and time taken for intubation. This study's findings will provide the first scientific evidence for an appropriate place for holding the ET during LEI, which we feel will help trainees improve their LEI technique.Trial registration: CTRI/2019/09/021201, Clinical Trials Registry India. http://ctri.nic.in/Clinicaltrials/advsearch.php. Registered 12th September 2019,

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Is there an optimal place to hold the endotracheal tube during direct laryngoscopy for patients undergoing surgery under general anesthesia? Protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05635-5 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Manisha Sahoo ◽

Swagata Tripathy ◽

Nitasha Mishra

Keyword(s):

General Anesthesia ◽

Endotracheal Tube ◽

Direct Laryngoscopy ◽

Controlled Trial ◽

Scientific Evidence ◽

Optimal Size ◽

Significance Level ◽

Intubation Difficulty ◽

Difficulty Scale ◽

Group 2

Abstract Background Endotracheal intubation by direct laryngoscopy is a widely performed lifesaving technique. Although there are guidelines for optimal size and depth of insertion of an endotracheal tube (ETT) for successful intubation, there is no consensus on the point at which it should be held along its length. This will arguably affect the time, ease, and success of the technique due to a difference in visualization and torque applied to the ETT after glottic visualization. We aim to compare the effect of 2 different sites of holding the ETT on time to intubation (TTI), intubation difficulty scale (IDS), and complications. Methods ASA 1–2 patients (>18 years) posted for surgery under general anesthesia, undergoing supervised intubation by anesthesia trainees (experience < 18 months), will be included. Patients with an anticipated difficult airway or unanticipated difficulty—CL grade 3 or 4 requiring the use of airway adjuncts—will be excluded. Patients will be randomized by a computer-generated number list, and allocation concealed with opaque sealed envelopes. The two sites for holding the ETT will be group 1 at 19 cm and group 2 at 24 cm. ETT marked at the selected site will be handed by the technician once the optimum position of the table, patient, and laryngoscopic view is confirmed by the intubator. The entire procedure will be video recorded. Two blinded assessors will independently review the videos to document the time to intubation and intubation difficulty score. A postoperative sore throat will be recorded. Sample size To detect a 20% difference in time to intubation between groups with a significance level of 5% and power of 85%, we will need a total of 298 patients. Accounting for data loss, we plan to recruit 180 patients in each group. Discussion This will be the first study to assess whether the site of holding the tube has any impact on the ease and time taken for intubation. The findings of this study will provide scientific evidence for suggesting an appropriate place for holding the ETT during direct laryngoscopy procedures. Trial registration Clinical Trials Registry India CTRI/2019/09/021201

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Effectiveness of SMS messaging for diarrhoea measurement: a factorial cross-over randomised controlled trial

10.21203/rs.3.rs-24263/v3 ◽

2020 ◽

Author(s):

Ryan Trevor Titus Rego ◽

Samuel Watson ◽

Philbert Ishengoma ◽

Philemon Langat ◽

Hezekiah Pireh Otieno ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Text Messaging ◽

Response Rate ◽

Financial Incentive ◽

Controlled Trial ◽

Response Rates ◽

Lower Response ◽

Lower Response Rate ◽

The Mean ◽

Randomised Controlled

Abstract Background Text messaging systems are used to collect data on symptom prevalence. Using a text messaging system, we evaluated the effects of question load, question frequency, and financial incentive on response rates and reported infant diarrhoea rates in an infant diarrhoea survey. Methods We performed a factorial cross-over randomised controlled trial of an SMS surveying system for infant diarrhoea surveillance with treatments: financial incentive (yes/no), question load (1-question/3-question), and questioning frequency (daily/fortnightly). Participants progressed through all treatment combinations over eight two-week rounds. Data were analysed using multivariable logistic regressions to determine the impacts of the treatments on the response rates and reported diarrhoea rates. Attitudes were explored through qualitative interviews. Results For the 141 participants, the mean response rate was 47%. In terms of percentage point differences (ppd), daily questioning was associated with a lower response rate than fortnightly (-1·2[95%CI:-4·9,2·5]); high (3-question) question loads were associated with a lower response rate than low (1-question) question loads (-7·0[95%CI:-10·8,-3·1]); and financial incentivisation was associated with a higher response rate than no financial incentivisation (6·4[95%CI:2·6,10·2]). The mean two-week diarrhoea rate was 36·4%. Daily questioning was associated with a higher reported diarrhoea rate than fortnightly (29·9[95%CI:22·8,36·9]); with little evidence for impact by incentivisation or question load. Conclusions Close to half of all participants responded to the SMS survey. Daily questioning evoked a statistically higher rate of reported diarrhoea, while financial incentivisation and low (1-question) question loads evoked higher response rates than no incentive and high (3-question) question loads respectively. Trial Registration The protocol was registered on ISRCTN on the 20 th of March 2019 under number ISRCTN11410773 .

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Optimising endotracheal length in adult cats: a retrospective CT study

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x211052214 ◽

2021 ◽

pp. 1098612X2110522

Author(s):

Alfonso Rodriguez ◽

Roger Medina-Serra ◽

Mark J Plested ◽

Kata Veres-Nyeki

Keyword(s):

Endotracheal Tube ◽

Endotracheal Intubation ◽

Intercostal Space ◽

Anatomical Landmarks ◽

Thoracic Ct ◽

First Rib ◽

The Mean ◽

Adult Cats ◽

Insertion Length ◽

Head Neck

Objectives The aim of this study was to determine the maximal endotracheal insertion length by measuring the larynx to carina (L–C) distance by means of CT. An additional objective was to establish certain anatomical landmarks to optimise the process of endotracheal intubation (ETI). Methods Head, neck and thoracic CT images from adult cats at a single referral hospital between 2013 and 2020 were retrospectively evaluated. After standardising and identifying key markers (larynx, carina and first rib) the L–C, larynx to first rib (L–1R) and first rib to carina (1R–C) distances were measured. Results Forty-five adult cats were enrolled in the study, from which a total of nine different breeds were identified. The L–C distance was 14.3 ± 1.1 cm. This was longer in male (14.7 ± 1.1 cm) than in female cats (13.5 ± 0.7 cm). The first rib (1R) was 8.8 ± 0.7 cm from the larynx and the mean 1R–C distance was 5.4 ± 0.7 cm. The carina was found within the fifth intercostal space in 93.3% (n = 42) of the cats. Conclusions and relevance The process of ETI in adult cats may be guided by using the L–C and L–1R distance for a maximal and optimal endotracheal tube introduction, respectively. In addition, the maximal insertion length may be guided by estimating the position of the carina parallel to the fifth intercostal space.

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Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017511 ◽

2018 ◽

Vol 8 (8) ◽

pp. e017511 ◽

Cited By ~ 1

Author(s):

Nishma Patel ◽

Rebecca J Beeken ◽

Baptiste Leurent ◽

Rumana Z Omar ◽

Irwin Nazareth ◽

...

Keyword(s):

General Practice ◽

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Health Service ◽

Usual Care ◽

Controlled Trial ◽

Cost Effective ◽

The Mean ◽

Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

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N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-019-3628-5 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Lauren Arancini ◽

Chiara C. Bortolasci ◽

Seetal Dodd ◽

Olivia M. Dean ◽

Michael Berk

Keyword(s):

Public Health ◽

Tobacco Smoking ◽

Rating Scales ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Trial Registration ◽

Diagnostic Statistics ◽

Salivary Cotinine ◽

Randomised Controlled ◽

Clinical Trials Registry

Abstract Background Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effective treatments. Predicated on promising preclinical and pilot clinical data, this paper presents a rationale and protocol for the trial of N-acetylcysteine (NAC) as a novel anti-craving smoking cessation aid. Methods Current smokers (n = 120) of at least 10 cigarettes a day are recruited through online advertisements, print publications and dissemination of flyers. Participants are randomised on a 1:1 ratio to receive either 16-week treatment of 1.8 g/day of NAC or placebo with all participants receiving quit support from the online QuitCoach tool. Participants are attending visits at baseline, 8 and 16 weeks with a 42-week post-discontinuation follow-up. The primary outcome measure is sustained abstinence at six months after treatment based on self-reported rating scales and confirmed by exhaled carbon monoxide and salivary cotinine levels. Secondary outcomes are timing of the first lapse and relapse, between-group cigarette consumption, withdrawal symptoms, general wellbeing and mood/anxiety symptoms. Between-group differences in adverse events and subgroup analyses for variables including gender and Diagnostic Statistics Manual 5 diagnostics will also be investigated. Discussion The planned trial addresses an issue of major importance to human health and, if an effect is shown, may result in substantial changes to the management of smoking and nicotine addiction with overt public health implications. Trial registration Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12617001478303. Registered on 19 October 2017.

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Screening for and management of comorbidities after a nurse-led program: results of a 3-year longitudinal study in 769 established rheumatoid arthritis patients

RMD Open ◽

10.1136/rmdopen-2019-000914 ◽

2019 ◽

Vol 5 (2) ◽

pp. e000914 ◽

Cited By ~ 3

Author(s):

Laure Gossec ◽

Martin Soubrier ◽

Frantz Foissac ◽

Anna Molto ◽

Pascal Richette ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Controlled Trial ◽

Wilcoxon Test ◽

Paired Data ◽

Registration Number ◽

The Mean ◽

Patient Advice ◽

Randomised Controlled ◽

Comorbidity Status

Background/purposeCardiovascular (CV) risk, cancer, infections and osteoporosis should be screened for in rheumatoid arthritis (RA). The objective was to assess 3-year effects of a nurse visit for comorbidity counselling.MethodsThis was an open long-term (3 years) extension of the Comorbidities and Education in Rheumatoid Arthritis 6-month randomised controlled trial in which patients with definite, stable RA were visiting a nurse for comorbidity counselling. Comorbidity status was assessed and nurses provided advice on screening and management, at baseline and 3 years later. A score was developed to quantify comorbidity screening and management: 0–100, where lower scores indicate better screening and management. The score was compared between baseline and 3-year assessment using a Wilcoxon test for paired data.ResultsOf the 970 recruited patients, 776 (80%) were followed-up at 2–4 years and 769 (79%) had available data for comorbidities at both time points: mean (±SD) age 58 (±11) years and mean disease duration 14 (±10) years; 614 (80%) were women, the mean Disease Activity Score 28 was 3.0±1.3, and 538 (70%) were receiving a biologic. At baseline, the mean comorbidity screening score was 36.6 (±19.9) and it improved at 3 years to 24.3 (±17.8) (p<0.0001), thus with a relative improvement of 33% (improvement of 12 points). CV risk screening, vaccination status and bone densitometry performance improved the most.ConclusionsComorbidity screening was suboptimal but improved notably over 3 years, after a nurse-led programme aiming at checking systematically for comorbidity screening and giving patient advice. This long-term efficacy pleads in favour of nurse-led interventions to better address comorbidities in RA.Trial registration numberNCT01315652

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A Randomised Controlled Trial Comparing Fibreoptic-Guided Tracheal Intubation through Two Supraglottic Devices: Ambu® Auragain™ Laryngeal Mask and LMA® Fastrach™

Anaesthesia and Intensive Care ◽

10.1177/0310057x1804600508 ◽

2018 ◽

Vol 46 (5) ◽

pp. 474-479 ◽

Cited By ~ 4

Author(s):

G. Preece ◽

I. Ng ◽

K. Lee ◽

P. Mezzavia ◽

R. Krieser ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Endotracheal Intubation ◽

Controlled Trial ◽

Muscle Relaxation ◽

Laryngeal Mask ◽

Supraglottic Airway ◽

Supraglottic Airway Devices ◽

Airway Pathology ◽

Airway Devices ◽

Randomised Controlled

The Ambu®AuraGain™ laryngeal mask (LM) (Ambu A/S, Ballerup, Denmark) is one of the few readily available second-generation supraglottic airway devices (SADs) that offer a conduit for fibreoptic-guided endotracheal intubation. We aimed to compare fibreoptic intubation through this device with the LMA® (laryngeal mask airway) Fastrach™ (Teleflex Medical, Co. Westmeath, Ireland), which has been a recommended dedicated rescue device for the management of the unanticipated difficult airway. This randomised controlled trial compared a previously described fibreoptic score in 116 patients with no known airway pathology, who had asleep fibreoptic endotracheal intubation via either the AuraGain LM or the LMA Fastrach. Time, ease and success rate of SAD and endotracheal tube (ETT) insertion and complications were recorded. The AuraGain LM demonstrated better laryngeal alignment with 29 out of 59 patients in the AuraGain LM (AG) group having a Grade 4 view (only vocal cords visible), compared to 20 out of 54 patients in the LMA Fastrach (FT) group (P=0.003). It allowed significantly quicker and easier ETT intubation when used as a conduit. The AuraGain LM was also quicker to insert compared to the Fastrach LMA. Similar rates of minor complications, such as sore throat and dysphonia occurred in both groups. Our study indicates that when used in patients with complete muscle relaxation and no known airway pathology, the AuraGain LM achieves better laryngeal alignment and quicker, easier and more successful fibreoptic-guided ETT intubation than the Fastrach LMA.

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Black tea is not significantly different from water in the maintenance of normal hydration in human subjects: results from a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114511000456 ◽

2011 ◽

Vol 106 (4) ◽

pp. 588-595 ◽

Cited By ~ 17

Author(s):

Carrie H. Ruxton ◽

Valerie A. Hart

Keyword(s):

Randomised Controlled Trial ◽

Human Subjects ◽

Controlled Trial ◽

Vigorous Physical Activity ◽

Black Tea ◽

Blood Cell Count ◽

Factorial Anova ◽

The Mean ◽

Randomised Controlled ◽

Boiled Water

There is a belief that caffeinated drinks, such as tea, may adversely affect hydration. This was investigated in a randomised controlled trial. Healthy resting males (n21) were recruited from the general population. Following 24 h of abstention from caffeine, alcohol and vigorous physical activity, including a 10 h overnight fast, all men underwent four separate test days in a counter-balanced order with a 5 d washout in between. The test beverages, provided at regular intervals, were 4 × 240 ml black (i.e. regular) tea and 6 × 240 ml black tea, providing 168 or 252 mg of caffeine. The controls were identical amounts of boiled water. The tea was prepared in a standardised way from tea bags and included 20 ml of semi-skimmed milk. All food taken during the 12 h intervention period was controlled, and subjects remained at rest. No other beverages were offered. Blood was sampled at 0, 1, 2, 4, 8 and 12 h, and a 24 h urine sample was collected. Outcome variables were whole blood cell count, Na, K, bicarbonate, total protein, urea, creatinine and osmolality for blood; and total volume, colour, Na, K, creatinine and osmolality for urine. Although data for all twenty-one participants were included in the analysis (mean age 36 years and mean BMI 25·8 kg/m2), nineteen men completed all conditions. Statistical analysis, using a factorial ANOVA approach within PROC MIXED, revealed no significant differences between tea and water for any of the mean blood or urine measurements. It was concluded that black tea, in the amounts studied, offered similar hydrating properties to water.

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Managing with Learning Disability and Diabetes: OK-Diabetes – a case-finding study and feasibility randomised controlled trial

Health Technology Assessment ◽

10.3310/hta22260 ◽

2018 ◽

Vol 22 (26) ◽

pp. 1-328 ◽

Cited By ~ 5

Author(s):

Allan House ◽

Louise Bryant ◽

Amy M Russell ◽

Alexandra Wright-Hughes ◽

Liz Graham ◽

...

Keyword(s):

Type 2 Diabetes ◽

Observational Study ◽

Learning Disability ◽

Diabetes Management ◽

Controlled Trial ◽

Self Management ◽

Feasibility Randomised Controlled Trial ◽

The Mean ◽

Randomised Controlled

BackgroundObesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population.ObjectivesTo develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU).DesignObservational study and an individually randomised feasibility RCT.SettingThree cities in West Yorkshire, UK.ParticipantsIn the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA1c) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m2or self-reported physical activity below national guideline levels.InterventionsStandardised SSM. TAU supported by an easy-read booklet.Main outcome measures(1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA1c, BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention.ResultsIn the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA1clevel was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7.1%, SD 1.4%]. The BMI of 65% of participants was > 30 kg/m2and of 21% was > 40 kg/m2. Many participants reported low mood, dissatisfaction with lifestyle and diabetes management and an interest in change. Non-response rates were high (45/147, 31%) for medical data requested from the primary care team. In the RCT, 82 participants were randomised. The mean baseline HbA1clevel was 56 mmol/mol (SD 16.5 mmol/mol; 7.3%, SD 1.5%) and the mean BMI was 34 kg/m2(SD 7.6 kg/m2). All SSM sessions were completed by 35 out of 41 participants. The adherence measure was obtained in 37 out of 41 participants. The follow-up HbA1clevel and BMI was obtained for 75 out of 82 (91%) and 77 out of 82 (94%) participants, respectively. Most participants reported a positive experience of the intervention. A low response rate and difficulty understanding the EuroQol-5 Dimensions were challenges in obtaining data for an economic analysis.LimitationsWe recruited from only 60% of eligible general practices, and 90% of participants were on a general practice learning disability register, which meant that we did not recruit many participants from the wider population with milder learning disability.ConclusionsA definitive RCT is feasible and would need to recruit 194 participants per arm. The main barrier is the resource-intensive nature of recruitment. Future research is needed into the effectiveness of obesity treatments in this population, particularly estimating the longer-term outcomes that are important for health benefit. Research is also needed into improving ways of assessing quality of life in adults with a learning disability.Trial registrationCurrent Controlled Trials ISRCTN41897033.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 26. See the NIHR Journals Library website for further project information.

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Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U)

BMJ Open ◽

10.1136/bmjopen-2020-046324 ◽

2021 ◽

Vol 11 (9) ◽

pp. e046324

Author(s):

Sarah Marchal ◽

Jade Janicot ◽

Julie Salicis ◽

Diane Demonchy ◽

Anne-Laure Herisse ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Study Protocol ◽

Urine Analysis ◽

Controlled Trial ◽

Contamination Rate ◽

Minimal Invasiveness ◽

Registration Number ◽

Randomised Controlled ◽

Tract Infections ◽

Clinical Trials Registry

IntroductionUrinary tract infections occur in around 1%–4% of boys and 3%–8% of girls under 2 years old. Diagnosis is difficult because of non-specific symptoms and the risk of urine analysis contamination depending on the sampling method used for precontinent infants. The American Academy of Pediatrics recommend transurethral catheterisation and suprapubic aspiration because of a low contamination rate but these techniques are invasive. On the other hand, while the National Institute for Health and Care Excellence advocate clean catch urine for its minimal invasiveness and acceptable contamination rate, it is difficult to accomplish in precontinent infants. Two recent methods have been described: the Quick-Wee method by Kaufman et al (suprapubic stimulation with cold saline-soaked gauze); and bladder stimulation by Herreros et al then by Tran et al (pubic tapping alternating with lumbar massage). This study aims to compare the effectiveness in collecting midstream urine by bladder stimulation vs the Quick-Wee method in infants under 1 year, before walking.Methods and analysisThis study is a multicentre randomised controlled trial of 230 infants under 1 year and before walking who need urine analysis, conducted in four paediatric emergency departments in France. Patients will be randomised into two groups: bladder stimulation and Quick-Wee method.The primary endpoint will be the success rate of voiding at least 2 mL of urine in less than 5 min.Secondary outcomes are the time to collect at least 2 mL of urine, comfort, quality of urine and the risk factors associated with failure of the two techniques.Ethics and disseminationThe study protocol was approved by the French national ethic committee (consultative committee of the protection of persons). The results of the study will be published in a peer-reviewed journal.Trial registration numberClinical Trials Registry - NCT04587999.Date and protocol version identifierOctober 2020, V.1.

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