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Background. Recurrent Clostridium difficile infection (CDI) with poor response to standard antimicrobial therapy is a growing medical concern. We aimed to investigate the outcomes of fecal microbiota transplant (FMT) for relapsing CDI using a frozen suspension from unrelated donors, comparing colonoscopic and nasogastric tube (NGT) administration. Methods. Healthy volunteer donors were screened and a frozen fecal suspension was generated. Patients with relapsing/refractory CDI were randomized to receive an infusion of donor stools by colonoscopy or NGT. The primary endpoint was clinical resolution of diarrhea without relapse after 8 weeks. The secondary endpoint was self-reported health score using standardized questionnaires. Results. A total of 20 patients were enrolled, 10 in each treatment arm. Patients had a median of 4 (range, 2–16) relapses prior to study enrollment, with 5 (range, 3–15) antibiotic treatment failures. Resolution of diarrhea was achieved in 14 patients (70%) after a single FMT (8 of 10 in the colonoscopy group and 6 of 10 in the NGT group). Five patients were retreated, with 4 obtaining cure, resulting in an overall cure rate of 90%. Daily number of bowel movements changed from a median of 7 (interquartile range [IQR], 5–10) the day prior to FMT to 2 (IQR, 1–2) after the infusion. Self-ranked health score improved significantly, from a median of 4 (IQR, 2–6) before transplant to 8 (IQR, 5–9) after transplant. No serious or unexpected adverse events occurred. Conclusions. In our initial feasibility study, FMT using a frozen inoculum from unrelated donors is effective in treating relapsing CDI. NGT administration appears to be as effective as colonoscopic administration. Clinical Trials Registration. NCT01704937.

Second-generation laryngeal mask airways are equipped with an additional lumen for a gastric tube, with the intention to reduce the risk of aspiration by draining gastric content. However, the effect of an inserted gastric tube through the gastric channel on gastric insufflation, a substantial part of the pathomechanism of aspiration, during positive-pressure ventilation is not clear. We hypothesized, that an inserted gastric tube increases the risk of gastric insufflation. Single center, prospective, randomized-controlled cross-over trial. Tertiary academic hospital in Germany. 152 patients, ASA I-III, scheduled for general anesthesia with a laryngeal mask airway. Gastric insufflation was investigated during an incremental pressure trial up to a maximum airway pressure of 30 cmH2O and during oropharyngeal leak pressure measurement with and without an inserted gastric tube while one of two laryngeal mask airways with different cuff designs (inflatable or thermoelastic) was used. Gastric insufflation was detected with real-time ultrasound. Frequency of gastric insufflation was higher with than without inserted gastric tube during the incremental pressure trial (10.9 % (16/147) vs. 2.7 % (4/147), p = 0.009) and during oropharyngeal leak pressure measurement (16.3 % (24/147) vs. 5.4 % (8/147), p = 0.004). Risk of gastric insufflation didn't differ between the two cuff-types (p = 0.100). Flow over the open gastric channel was associated with gastric insufflation during positive-pressure ventilation (p = 0.003) and during oropharyngeal leak pressure measurement (p = 0.049). Incidence of postoperative nausea and vomiting was higher in patients in which gastric insufflation was detected, compared to others (17.1 % (6/35) vs. 5.4 % (6/112), p = 0.037). Placement of a gastric tube through the gastric channel of a second-generation laryngeal mask airway, independent of the cuff-type, increases the risk of gastric insufflation. Flow over the gastric channel indicate a higher risk of gastric insufflation and gastric insufflation may increase the risk of postoperative nausea and vomiting. [Display omitted] •Risk of gastric insufflation in 2nd generation LMAs increases with a gastric tube.•Cuff-type of 2nd generation LMA does not influence the risk of gastric insufflation.•Flow over the gastric channel is a sign of an increased risk of gastric insufflation.•Patients with gastric insufflation experienced PONV more often at the PACU.

Background Palliation to late dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Intermittent oro-esophageal tube feeding (IOE) is an emerging enteral nutrition mode that can address nutrition and quality of life issues related to nasogastric tube feeding (NGT). Objectives This study aims to investigate the effect of IOE versus NGT in late dysphagia after radiotherapy for NPC. Methods This randomized controlled study included 82 NPC survivors with late dysphagia after radiotherapy. The subjects were randomized divided into the IOE and NGT groups ( n 1 =  n 2 = 41). Both groups received standard-of-care rehabilitation. Enteral nutrition supports were administered through IOE or NGT accordingly. This study lasted 2 weeks for each participant. The primary outcome was nutritional status including albumin, hemoglobin, total serum protein, and body mass index. The secondary outcomes were (i) the functional oral intake scale (FOIS), (ii) the penetration-aspiration scale (PAS), (iii) oral transit time (OTT), (iv) hyoid pause time (HPT), (v) pharyngeal transport time (PTT), and (vi) swallowing-quality of life (SWAL-QoL). Results Three cases quitted the study halfway and there were no significant baseline differences between the IOE ( n  = 40) and NGT ( n  = 39) groups. Both time and group effects were significant in all nutritional indicators. The time effect was significant in the FOIS levels, OTT and PTT, while the group effect was not. Either time or group effect were insignificant in the PAS levels and HPT. Both group and time effects were significant in the SWAL-QoL total scores ( z Group  = 5.080, P  < 0.001; z Time  = 18.005, P  < 0.001). The significance of time and group effects varied across different dimensions of the SWAL-QoL. Conclusions Rehabilitation interventions can improve swallowing function among NPC survivors with late dysphagia after radiotherapy. In this population who received standard-of-care rehabilitation, IOE is more conducive to the improvement of nutritional status, and swallowing-related quality of life. Trial registration ClinicalTrials.gov Identifier: NCT06301763.

Background Nasoenteric feeding tubes are necessary in hospitalized children to deliver nutrition and medication. Traditionally, adhesive tape secures these feeding tubes but fails to prevent 40% of tube dislodgements. The nasal bridle, a thin plastic anchor placed around the vomer bone, is an increasingly used method for tube securement. Our objective is to compare AMT Bridle Pro® nasal bridle versus conventional tape to safely reduce tube dislodgement in pediatric patients. Methods A prospective, open-label randomized controlled trial was carried out between February 2020 and January 2021 at a tertiary pediatric hospital. Infants, children, and adolescents less than 18 years of age with an order to place a nasogastric or post-pyloric feeding tube were approached for enrollment. Exclusion criteria included facial trauma, nasal airway obstruction, or thrombocytopenia. After obtaining consent, patients were randomized to AMT Bridle Pro® nasal bridle or conventional tape to secure the feeding tube. The primary outcome was the frequency of feeding tube dislodgement, defined as unintentional tube removal or change in position. Secondary outcomes included days to feeding tube dislodgement, number of dislodgements per 10 tube days, resource use, and complications from tube securement. Results A total of 35 patients were randomized and equally split to the bridle ( n  = 17) and tape arm ( n  = 18). The primary analysis revealed the rate of feeding tube dislodgement over 30 days was significantly higher in the tape group compared to the bridle group with an attributable risk reduction of 57% (hazard ratio = 6.3, 95% CI 2.4–16.5, p  < 0.001). After 30 days, tubes dislodged at a proportion 88% (15) in the tape arm compared to 31% (5) in the bridle arm (risk ratio = 2.82; 95% CI: 1.34–5.96; p  = 0.001). There were no serious adverse events. Four patients in the tape group developed erythema and skin breakdown where the tube was secured with tape. One patient was withdrawn from the bridle group because they developed erythema on the nasal septum after placement, which resolved quickly upon removal of the bridle. Conclusion Securing nasoenteric feeding tubes with the AMT Bridle Pro® can effectively reduce tube dislodgements in hospitalized children. Trial registration ClinicalTrials.gov NCT04621734. Registered on November 3, 2020. https://clinicaltrials.gov/search?cond=NCT04621734 .

Objective The total enteroscopy rate of single-balloon enteroscopy (SBE) using air insufflation is not satisfactory, and whether carbon dioxide (CO2) insufflation increases the total enteroscopy rate of SBE is unknown. This randomised controlled trial aimed to determine whether CO2 insufflation facilitates the intubation depth and total enteroscopy rate of SBE. Design A total of 214 eligible patients referred for SBE were randomised to receive either air or CO2 insufflation, and included in the intention-to-test (ITT) analysis. In addition, 199 patients in whom enteroscopy was completed were included in the per-protocol (PP) analysis. Both the patients and endoscopists were blinded, and the intubation depth and total enteroscopy rate were defined as the primary outcomes. Results The CO2 group showed a superiority of intubation in the ITT analysis (oral route: 323.8±64.2 vs 238.3±68.6 cm; anal route: 261.6±74.2 vs 174.7±62.1 cm, both p<0.001), and the total enteroscopy rate (34.9% vs 17.6%, p=0.006). Similar results were obtained in a PP analysis for both outcomes. In addition, in the PP analysis, the addition of circumference after the procedure was less in the CO2 group (0.8±0.6 vs 3.3±1.8 cm, p=0.005) for the oral route. No serious complications were reported. The overall percentage of procedures with significant pathological findings was 52.8%; the rates were 58.5% and 47.2% (p=0.100, ITT analysis) in the CO2 and air groups, respectively. Conclusions CO2 insufflation improves the intubation depth and total enteroscopy rate in SBE with a good safety profile and acceptability compared with that of air, and thus is recommended for clinical utilisation. Trial registration number ClinicalTrial.gov identifier: NCT01758900.

Benefits of skills lab training are widely accepted, but there is sparse research on its long-term effectiveness. We therefore conducted a prospective, randomised controlled-trial to investigate whether in a simulated setting students trained according to a \"best practice\" model (BPSL) perform two skills of different complexity (nasogastral tube insertion, NGT; intravenous cannulation, IVC) better than students trained with a traditional \"see one, do one\" teaching approach (TRAD), at follow-up of 3 or 6 months. 94 first-year medical students were randomly assigned to one of four groups: BPSL training or TRAD teaching with follow-up at 3 (3M) or 6 (6M) months. BPSL included structured feedback, practice on manikins, and Peyton's \"Four-Step-Approach\", while TRAD was only based on the \"see one - do one\" principle. At follow-up, manikins were used to assess students' performance by two independent blinded video-assessors using binary checklists and a single-item global assessment scale. BPSL students scored significantly higher immediately after training (NGT: BPSL3M 94.8%±0.2 and BPSL6M 95.4%±0.3 percentage of maximal score ± SEM; TRAD3M 86.1%±0.5 and TRAD6M 84.7%±0.4. IVC: BPSL3M 86.4%±0.5 and BPSL6M 88.0%±0.5; TRAD3M 73.2%±0.7 and TRAD6M 72.5%±0.7) and lost significantly less of their performance ability at each follow-up (NGT: BPSL3M 86.3%±0.3 and TRAD3M 70.3%±0.6; BPSL6M 89.0%±0.3 and TRAD6M 65.4%±0.6; IVC: BPSL3M 79.5%±0.5 and TRAD3M 56.5%±0.5; BPSL6M 73.2%±0.4 and TRAD6M 51.5%±0.8). In addition, BPSL students were more often rated clinically competent at all assessment times. The superiority at assessment after training was higher for the more complex skill (IVC), whereas NGT with its lower complexity profited more with regard to long-term retention. This study shows that within a simulated setting BPSL is significantly more effective than TRAD for skills of different complexity assessed immediately after training and at follow-up. The advantages of BPSL training are seen especially in long-term retention.

IntroductionNasogastric tubes (NGTs) are standard practice in the management of adhesive small bowel obstruction (ASBO). Their insertion can be associated with significant patient discomfort and complications. Current research suggests that patients with ASBO managed with NGTs may experience poorer outcomes and higher rates of operative intervention compared with those managed without. However, to date, there are no prospective clinical trials evaluating this.Methods and analysisThis study will be designed as a single centre, prospective, non-inferiority randomised controlled trial to determine if the avoidance of an NGT is non-inferior to its use in ASBO. Patients meeting inclusion criteria will be randomised to either receive an NGT or no NGT for ASBO management. The primary outcome will be the rate of operative intervention as determined by review of medical records at day 30 post discharge. Secondary outcomes will include rate of bowel resection or bowel ischaemia, length of hospital and intensive care unit (ICU) stay, time to operative intervention, rate of ICU admission, incidence of postoperative complications (Clavien-Dindo classification), quality of life scores (European Quality of Life 5 Dimension 5 Level: EQ-5D-5L) at admission, day 30 and day 90, 90-day mortality, incidence of pulmonary complications (Melbourne Group Scale), rate of NGT specific complications and rate of Gastrografin use. The study will be powered at 80% to detect a clinically relevant difference of 10% between groups receiving an NGT compared with no NGT, requiring a total of 490 study participants. Statistical analysis will follow intention to treat principles. Differences between treatment arms will be summarised using mean differences, 95% CIs and p values.Ethics and disseminationThis study has been approved by the Hunter New England Human Research Ethics Committee (2023/ETH00296). Results will be disseminated through peer-reviewed publication and conference presentations.Trial registration numberThis study has been registered prospectively in the Australia and New Zealand Clinical Trials Registry (ACTRN12623000341628).

•This study compared intermittent oro-esophageal and nasogastric tubes in cerebral small vessel disease patients.•Intermittent oro-esophageal tubes showed advantages in improving function and nutritional status.•Intermittent oro-esophageal tubes can significantly improve aspiration pneumonia. This study reported the clinical effect of intermittent oro-esophageal tube feeding (IOE) versus nasogastric tube feeding (NGT) on cerebral small vessel disease (CSVD) patients with dysphagia. This randomized controlled study included 60 CSVD patients with dysphagia who received routine treatment. Participants were randomly divided into the intervention group (with IOE, n = 30) and the control group (with NGT, n = 30). The study lasted 15 days for each patient and assessments were conducted at baseline and after treatment. The primary outcome was dysphagia including Penetration-Aspiration Scale and Functional Oral Intake Scale. The secondary outcomes were 1) nutritional status, including (i) body mass index, (ii) serum albumin, (iii) hemoglobin, 2) aspiration pneumonia, 3) activities of daily living (ADL), 4) quality of life (QOL). At admission, there were no significant differences (P > 0.05) in baseline assessment. After treatment, both groups showed significant improvement in dysphagia, nutritional status, ADL, and QOL. There were significant differences (P < 0.05) between the two groups in dysphagia, nutritional status [body mass index: (19.53 ± 1.40) kg/m2 vs. (18.35 ± 1.54) kg/m2; albumin: (42.06 ± 2.64) g/L vs. (39.49 ± 2.77) g/L; hemoglobin: (128.85 ± 6.34) mg/L vs. (123.14 ± 7.92) mg/L], aspiration pneumonia (6.67% vs. 33.33%), ADL [(69.07 ± 6.33) vs. (63.56 ± 6.75)], and QOL [(78.07 ± 8.64) vs. (72.48 ± 7.76)]. There were no severe adverse events during the treatment. Compared to NGT, IOE demonstrated advantages in improving dysphagia, nutritional status, ADL, QOL, and aspiration pneumonia in CSVD patients with dysphagia who received routine treatment.

Purpose We studied whether a newly available gastric tube insertion guide (Fuji Medical, Tokyo, Japan) was effective in insertion of a nasogastric tube. Methods Sixty anesthetized patients were randomly allocated to three groups, and we attempted to insert a nasogastric tube with a blind technique (Group B), with the lateral neck pressure (Group L), or with the tube guide (Group G). If the insertion failed in Group B or L, its insertion was attempted with the tube guide. Primary outcome measure was the insertion success rate within 300 s. Results The success rate in Group G (19 of 20 patients) was significantly higher than Group L (13 of 20 patients) ( P  = 0.04; 95% confidence intervals for difference: 16–44%), and than Group B (11 of 19 patients) ( P  = 0.008; 23–50%). In the 15 patients of Groups B and L, in whom insertion had failed, insertion with the tube guide was successful in 14 patients. There was no significant difference in insertion time between the groups, but in patients in whom insertion was successful, it was significantly longer in Group G (median of 147 s) than in Group L (66 s) ( P  < 0.01) and Group B (46 s) ( P  < 0.01). Minor complications occurred in 2 patients in Group B, 1 in Group L, and 5 in Group G ( P  > 0.05). Conclusion We conclude that the gastric tube insertion guide (Fuji Medical, Tokyo, Japan) may be useful when the conventional method of insertion has failed.

To verify the efficacy and safety of bedside ultrasound-guided nasointestinal tube (NIT) placement techniques in critically ill patients in the ICU. 100 Critically ill patients were selected and were randomly enrolled into a bedside ultrasound guidance (BUG) group (BUG guiding the NIT placement) and a traditional blind insertion (TBI) group, with 50 cases in both. The efficacy and safety of these tube placements were compared. The success rate of intubation in the BUG group (74%) was higher than that in the TBI group (44%). The proportion of patients in the BUG group who had catheterization sites in the intestine (72%) was higher than that in the TBI group (46%) (P < .05). The average number of tube insertions and mean time of successful intubation time in the BUG group was slightly higher than those in the TBI group [(1.22 ± 0.00) times vs. (1.20 ± 1.00) times and (24.40 ± 0.50) min vs. (20.72 ± 0.50) min) (P > .05) respectively]. Bedside ultrasound-guided nasojejunal tube has a good outcome in ICU patients with critical conditions, can improve the success rate of intubation, and has a certain safety.