Determining efficacy of dynamic multimedia bowel preparation instructions versus standard instructions on adenoma detection and patient reported measures (DIGICLEAN trial): a study protocol for a multicentre, colonoscopist-blinded, randomised controlled trial

Introduction
Colonoscopy plays important roles in bowel cancer screening and treatment. Poor bowel preparation occurs in 20–25% of colonoscopies. This negatively impacts adenoma and sessile serrated lesion detection rates, procedural time, requirement for repeat colonoscopies, healthcare costs and likelihood of patient withdrawal from screening programmes. It is unclear whether a combination of multimedia modalities can improve bowel preparation quality, adenoma detection rates and patient-reported measures in those undergoing colonoscopy assessment.

Methods
The DIGICLEAN trial is a prospective, parallel, multicentre, colonoscopist-blinded, randomised controlled trial. The trial will enrol 1294 participants aged 45 years and older who are indicated for a colonoscopy as an outpatient with a positive faecal occult blood test, iron deficiency anaemia or rectal bleeding. Participants will be randomised into the interventional arm, where bowel preparation instructions are delivered via a web-based application which uses scheduled short messaging service, regular patient survey assessment, email and videos; or the control arm, where routine standard written, verbal or emailed instructions are administered. The web-based application will assess patient-reported bloating, constipation and dietary adherence leading up to the colonoscopy. Depending on patient responses, additional aperients may be encouraged digitally in the interventional arm with same instructions made available in written format for the control arm. Patient-reported measures will be collected in both arms the day after the procedure using the validated Newcastle ENDOPREM questionnaire. In some sites, participants will undergo digital pre-anaesthetic screening as well. The co-primary endpoints are the adenoma detection rates and patient-reported measures taken after the colonoscopy.

Ethics and dissemination
Ethics approval for this study was obtained from the Western Sydney Local Health District Human Research Ethics Committee (2022/ETH00059). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.

Trial registration number
ACTRN12622000747729.

Leggi
Luglio 2023

Individualised versus standard duration of antibiotic therapy in children with acute uncomplicated febrile urinary tract infection: a study protocol and statistical analysis plan for a multicentre randomised clinical trial

Introduction
Febrile urinary tract infection is one of the most common bacterial infections in children. Currently, recommended antibiotic duration is 10 days. However, recent evidence suggests that 90%–95% of children with febrile urinary tract infections are afebrile and clinically improved 48–72 hours after treatment initiation. Accordingly, individualised duration of antibiotic therapy, according to the recovery time, might be more beneficial than current recommendations, but no evidence exists.

Methods and analysis
An open-label randomised clinical trial equally randomising children aged 3 months to 12 years from eight Danish paediatric departments with uncomplicated febrile (≥38°C) urinary tract infection to either individualised or standard duration of antibiotic therapy. Children allocated to individualised duration of antibiotic therapy will terminate antibiotic therapy 3 days after clinical improvement with no fever, flank pain or dysuria. Children allocated to standard duration will receive 10 days of antibiotic therapy. Co-primary outcomes are non-inferiority for recurrent urinary tract infection or death within 28 days after the end of treatment (non-inferiority margin 7.5 percentage points) and superiority for the number of days with antibiotic therapy within 28 days after treatment initiation. Seven other outcomes will also be assessed. A total of 408 participants are needed to detect non-inferiority (one-sided alpha 2.5%; beta 80%).

Ethics and dissemination
This trial has been approved by the Ethics Committee (H-21057310) and the Data Protection Agency (P-2022-68) in Denmark. Regardless of the trial’s findings (whether positive, negative or inconclusive), the results will be compiled into one or more manuscripts for publication in international peer-reviewed scientific journals and presented at conferences.

Trial registration number
NCT05301023.

Leggi
Giugno 2023

High-Flow Nasal Oxygen vs Standard Oxygen Therapy and Length of Hospital Stay in Children With Acute Hypoxemic Respiratory Failure

To the Editor A recent randomized clinical trial reported that children who received early high-flow nasal oxygen therapy for mild to moderate acute hypoxemic respiratory failure had a significantly longer length of stay in the hospital than those who initially received standard oxygen therapy. Although we appreciate the authors’ list of hypotheses for why children allocated to high-flow oxygen therapy had a prolonged length of stay, we believe there may be some other important explanations for this trial’s finding.

Leggi
Maggio 2023

High-Flow Nasal Oxygen vs Standard Oxygen Therapy and Length of Hospital Stay in Children With Acute Hypoxemic Respiratory Failure—Reply

In Reply The Letter by Dr Hsu and colleagues provides further insight into the reasons why children who were randomized to high-flow nasal oxygen therapy had a longer length of hospital stay than children treated with standard oxygen therapy in our study. We agree with the Letter authors’ comments, except that our study protocol provided no additional observation period after cessation of high-flow oxygen therapy, so this factor could not have substantially contributed to the results. We support the notion that there are excessive ICU admissions for infants with bronchiolitis. The PARIS-2 trial excluded infants with bronchiolitis because they were studied in the PARIS-1 trial.

Leggi
Maggio 2023

Response to letter to the editor: over-the-scope clips versus standard treatment

We thank Barkun et al1 for their comments on our study.2 We are aware of the limitations of our study, which have extensively been discussed in our manuscript. However, we would like to make some additional comments. We aimed to select high-risk patients only and used complete Rockall Score as selection criteria. Whether this score is the perfect tool to identify patients benefiting most from primary over-the-scope clips (OTSC) therapy remains unclear. Indeed, we did not balance baseline characteristics and the number of large lesions ( >20 mm) was three times higher in the standard group. This might have influenced study outcomes, as large ulcers are more difficult to treat with standard clips, which might have resulted in OTSC rescue therapy more frequently. However, large lesions can be difficult to treat with OTSC as well. Barkun et al comment that limited benefit for primary OTSC therapy for…

Leggi
Maggio 2023

Effect of the machine learning-derived Hypotension Prediction Index (HPI) combined with diagnostic guidance versus standard care on depth and duration of intraoperative and postoperative hypotension in elective cardiac surgery patients: HYPE-2 – study protocol of a randomised clinical trial

Introduction
Hypotension is common during cardiac surgery and often persists postoperatively in the intensive care unit (ICU). Still, treatment is mainly reactive, causing a delay in its management. The Hypotension Prediction Index (HPI) can predict hypotension with high accuracy. Using the HPI combined with a guidance protocol resulted in a significant reduction in the severity of hypotension in four non-cardiac surgery trials. This randomised trial aims to evaluate the effectiveness of the HPI in combination with a diagnostic guidance protocol on reducing the occurrence and severity of hypotension during coronary artery bypass grafting (CABG) surgery and subsequent ICU admission.

Methods and analysis
This is a single-centre, randomised clinical trial in adult patients undergoing elective on-pump CABG surgery with a target mean arterial pressure of 65 mm Hg. One hundred and thirty patients will be randomly allocated in a 1:1 ratio to either the intervention or control group. In both groups, a HemoSphere patient monitor with embedded HPI software will be connected to the arterial line. In the intervention group, HPI values of 75 or above will initiate the diagnostic guidance protocol, both intraoperatively and postoperatively in the ICU during mechanical ventilation. In the control group, the HemoSphere patient monitor will be covered and silenced. The primary outcome is the time-weighted average of hypotension during the combined study phases.

Ethics and dissemination
The medical research ethics committee and the institutional review board of the Amsterdam UMC, location AMC, the Netherlands, approved the trial protocol (NL76236.018.21). No publication restrictions apply, and the study results will be disseminated through a peer-reviewed journal.

Trial registration number
The Netherlands Trial Register (NL9449), ClinicalTrials.gov (NCT05821647).

Leggi
Maggio 2023

Multicentre study protocol comparing standard NRP to deveLoped Educational Modules for Resuscitation of Neonates in the Delivery Room with Congenital Heart Disease (LEARN-CHD)

Introduction
Infants born with critical congenital heart defects (CCHDs) have unique transitional pathophysiology that often requires special resuscitation and management considerations in the delivery room (DR). While much is known about neonatal resuscitation of infants with CCHDs, current neonatal resuscitation guidelines such as the neonatal resuscitation programme (NRP) do not include algorithm modifications or education specific to CCHDs. The implementation of CCHD specific neonatal resuscitation education is further hampered by the large number of healthcare providers (HCPs) that need to be reached. Online learning modules (eLearning) may provide a solution but have not been designed or tested for this specific learning need. Our objective in this study is to design targeted eLearning modules for DR resuscitation of infants with specific CCHDs and compare HCP knowledge and team performance in simulated resuscitations among HCPs exposed to these modules compared with directed CCHD readings.

Methods and analysis
In a prospective multicentre trial, HCP proficient in standard NRP education curriculum are randomised to either (a) directed CCHD readings or (b) CCHD eLearning modules developed by the study team. The efficacy of these modules will be evaluated using (a) individual preknowledge/postknowledge testing and (b) team-based resuscitation simulations.

Ethics and dissemination
This study protocol is approved by nine participating sites: the Boston Children’s Hospital Institutional Review Board (IRB-P00042003), University of Alberta Research Ethics Board (Pro00114424), the Children’s Wisconsin IRB (1760009-1), Nationwide Children’s Hospital IRB (STUDY00001518), Milwaukee Children’s IRB (1760009-1) and University of Texas Southwestern IRB (STU-2021-0457) and is under review at following sites: University of Cincinnati, Children’s Healthcare of Atlanta, Children’s Hospital of Los Angeles and Children’s Mercy-Kansas City. Study results will be disseminated to participating individuals in a lay format and presented to the scientific community at paediatric and critical care conferences and published in relevant peer-reviewed journals.

Leggi
Aprile 2023