prospective randomised trial
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Author(s):  
Vincent D Gaertner ◽  
Christoph Martin Rüegger ◽  
Dirk Bassler ◽  
Eoin O'Currain ◽  
C Omar Farouk Kamlin ◽  
...  

ObjectiveWe sought to determine the effect of stimulation during positive pressure ventilation (PPV) on the number of spontaneous breaths, exhaled tidal volume (VTe), mask leak and obstruction.DesignSecondary analysis of a prospective, randomised trial comparing two face masks.SettingSingle-centre delivery room study.PatientsNewborn infants ≥34 weeks’ gestation at birth.MethodsResuscitations were video recorded. Tactile stimulations during PPV were noted and the timing, duration and surface area of applied stimulus were recorded. Respiratory flow waveforms were evaluated to determine the number of spontaneous breaths, VTe, leak and obstruction. Variables were recorded throughout each tactile stimulation episode and compared with those recorded in the same time period immediately before stimulation.ResultsTwenty of 40 infants received tactile stimulation during PPV and we recorded 57 stimulations during PPV. During stimulation, the number of spontaneous breaths increased (median difference (IQR): 1 breath (0–3); padj<0.001) and VTe increased (0.5 mL/kg (−0.5 to 1.7), padj=0.028), whereas mask leak (0% (−20 to 1), padj=0.12) and percentage of obstructed inflations (0% (0–0), padj=0.14) did not change, compared with the period immediately prior to stimulation. Increased duration of stimulation (padj<0.001) and surface area of applied stimulus (padj=0.026) were associated with a larger increase in spontaneous breaths in response to tactile stimulation.ConclusionsTactile stimulation during PPV was associated with an increase in the number of spontaneous breaths compared with immediately before stimulation without a change in mask leak and obstruction. These data inform the discussion on continuing stimulation during PPV in term infants.Trial registration numberAustralian and New Zealand Clinical Trial Registry (ACTRN12616000768493).


2021 ◽  
pp. 004947552110589
Author(s):  
Vipin Sharma ◽  
Uday Somashekar ◽  
Dileep Singh Thakur ◽  
Reena Kothari ◽  
Dhananjaya Sharma

Enteral alimentation can be administered continuously, cyclically, intermittently, or by a bolus technique. Current literature does not suggest superiority of any one regime. Most studies have used nasogastric feeds, little is known about the outcome of jejunal feeding. This study compares the efficiency and safety of bolus and continuous jejunostomy feeding. 46 adults undergoing a feeding jejunostomy for nutritional support or as an adjunct to a major upper GI surgery, were randomised to bolus feeding (BF group, n = 24) and continuous feeding (CF group, n = 22). Demographic, anthropometric, and laboratory parameters were measured preoperatively and on post-operative days (POD) 3, 7, 15, and 30. These parameters; as well as nutritional and functional outcomes, and complications at POD 30; were comparable in both groups. Both groups tolerated jejunal feeds well. Bolus feeding is simple, inexpensive, and permits daily physical activities. Hence it may be preferred over continuous jejunostomy feeding for enteral alimentation.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Duncan Muir ◽  
Niall Dempster ◽  
Bruno Sgromo ◽  
Richard Gillies ◽  
Jeremy Cobbold ◽  
...  

Abstract Aims Non-alcoholic fatty liver disease (NAFLD) represents the hepatic manifestation of the metabolic syndrome.There are no licensed pharmacotherapies for NAFLD, and it is rapidly becoming the leading cause of liver failure worldwide.Bariatric surgery (BS) is an effective and durable intervention for weight loss and type 2 diabetes (T2D) but is not recommended in the UK’s NICE guidelines for NAFLD management.We aimed to determine whether BS was associated with NAFLD regression. Methods 1067 people with NAFLD were included in this observational cohort study.Liver histology/validated non-invasive biomarkers were used to diagnose NAFLD.Markers of liver and metabolic health were recorded longitudinally for participants undergoing hepatology-led (n = 702) or BS (n = 365) management in a UK tertiary centre. 1-year outcomes were compared using mixed models. 5-year mortality was compared using Cox proportional-hazards regression. Results T2D prevalence was similar between cohorts (p = 0.06). Differences in other baseline factors were observed (age, gender, and body mass index (BMI), all p &lt; 0001). BS showed a significantly lower adjusted 5-year mortality (p = 0.02). Both interventions were associated with improved biomarkers of liver health e.g. ALT (p = 0.00). Greater improvements in targets of NAFLD management such as HbA1c (p = 0.00) and BMI (p = 0.00) were observed after BS. Conclusions BS showed an improved 5-year survival compared to hepatology-led management. This may be explained by greater improvements in key targets for NAFLD regression in the BS cohort. However, residual confounding despite adjusted survival analysis cannot be excluded. A prospective randomised trial is recommended to ensure fair comparison of these interventions and enhance the clinical management of NAFLD.


Author(s):  
Robert Ruemmler ◽  
Jakob Stein ◽  
Bastian Duenges ◽  
Miriam Renz ◽  
Erik Kristoffer Hartmann

Abstract Background Mechanical chest compression devices are accepted alternatives for cardiopulmonary resuscitation (CPR) under specific circumstances. Current devices lack prospective and comparative data on their specific cardiovascular effects and potential for severe thoracic injuries. Objectives To compare CPR effectiveness and thoracic injuries of two mechanical chest compression devices in pigs. Study design Prospective randomised trial. Animals Eighteen male German landrace pigs. Methods Ventricular fibrillation was induced in anaesthetised and instrumented pigs and the animals were randomised into two intervention groups. Mechanical CPR was initiated by means of LUCAS™ 2 (mCCD1) or Corpuls™ cpr (mCCD2) device. Advanced life support was applied for a maximum of 10 cycles and animals achieving ROSC were monitored for 8 h. Ventilation/perfusion measurements were performed and blood gas analyses were taken. Thoracic injuries were assessed via a standardised damage score. Results Five animals of the mCCD1 group and one animal of the mCCD2 group achieved ROSC (p = 0.048). Only the mCCD1 animals survived until the end of the monitoring period (p < 0.01). MCCD1 animals showed less pulmonary shunt (p = 0.025) and higher normal V/Q (p = 0.017) during CPR. MCCD2 animals showed significantly more severe thoracic injuries (p = 0.046). Conclusion The LUCAS 2 device shows superior resuscitation outcomes and less thoracic injuries compared to Corpuls cpr when used for experimental CPR in juvenile pigs. Researchers should be aware that different mCCDs for experimental studies may significantly influence the respective outcome of resuscitation studies and affect comparability of different trials. Controlled human and animal CPR studies and a standardised post-resuscitation injury evaluation could help to confirm potential hazards. Trial registration Trial approval number: G16–1-042-E4.


2021 ◽  
Vol 13 (3) ◽  
pp. 223-231
Author(s):  
S Restaino ◽  
V Vargiu ◽  
A Rosati ◽  
M Bruno ◽  
G Dinoi ◽  
...  

Background: The introduction of ultra-high-definition laparoscopic cameras (4K), by providing stronger monocular depth perception, could challenge the existing 3D technology. There are few available studies on this topic, especially in gynaecological setting. Objectives: Prospective, single institution, randomised clinical trial (NCT04209036). Materials and Methods: The two laparoscopes utilised were the 0°ULTRA Telescopes with 4K technology and the 0°3D-HD by Olympus. The surgeons were all trainees and in their last year of residency and who had obtained the certificate of first or second level of the Gynaecological Endoscopic Surgical Education and Assessment program - GESEA program. Twenty-nine patients with benign uterine pathology were enrolled. Main outcome measures: To compare if the use three-dimensional (3D) versus ultra-high-definition laparoscopic vision system (4K) for total laparoscopic hysterectomy performed by trainees was associated with a shorter operative time. Results: The 3D vision system did not prove to be superior to the 4K vision system. Operators reported significantly more vision-related side effects when using 3D than 4K. Completing the GESEA training program was the only factor with a positive and statistically significant impact on the overall time of the procedure, especially when greater dexterity and tissue handling were required. Conclusions: Neither technology used proved superior to the other, although operators showed a preference for 4K over 3D due to the lower number of visual side effects. Attendance at courses on laparoscopic simulators and training programs allowed trainees to demonstrate excellent surgical skills.


Author(s):  
Andreas Joos ◽  
Dieter Bussen ◽  
Christian Galata ◽  
Christoph Reißfelder ◽  
Alexander Herold ◽  
...  

Abstract Aim Bowel movements after reconstructive anorectal surgery may negatively affect surgical outcome. This study was aimed to assess any differences between a standard diet (SD) and the enteral resorbable diet (ED) in terms of operative outcomes and patient tolerance after fistulectomy with primary sphincter reconstruction. Method Adult patients undergoing elective fistulectomy with primary sphincter reconstruction for anorectal and rectovaginal fistulas were eligible for inclusion. Patients were intraoperatively randomised to receive either the ED and peristalsis-inhibiting medication (ED) or a SD. The primary endpoint was the healing rate. Secondary endpoints included continence scores, complications and quality of life. Sample size calculation resulted in the analysis of 60 patients to detect a difference in fistula recurrence of 30% with 70% power and a 5% significance level. Results Sixty-six patients (24 women) were prospectively and randomly assigned to the ED (n = 34: 51%) or a SD (n = 32; 48%); mean age was 47 (18-74) years. The primary healing rate was 64 out of 66 patients (96%). No statistical difference in healing rate was seen between the groups. However, patient satisfaction was significantly higher in the SD group (P < 0.0001). Conclusions Fistulectomy with primary sphincter reconstruction is a safe method with low complication rates. Postoperative stool behaviour has no significant influence on the healing rate but has a significant negative impact on patient satisfaction. Therefore, maintaining a standard diet seems to be preferable following reconstructive anal surgery. Trial registration The trial was registered with the German Clinical Trials Register (DRKS00020524).


Author(s):  
Okan ALKIŞ ◽  
Mehmet Sevim ◽  
Ibrahim Kartal ◽  
Aykut Baser ◽  
Halil Ivelik ◽  
...  

Objectives: Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive method used in OAB treatment. We aimed to compare the effectiveness of the once a week and three times a week TTNS procedure in women diagnosed with wet type refractory OAB. Methods: A total of 60 patients diagnosed with wet type OAB was refractory to medical treatment included in the study. Participants were equally and randomly divided into two groups: TTNS treatment was performed with a time duration of 30 minutes for 12 weeks, once a week to Groıp-I and three times a week to Group-II. Pre and post-treatment OAB-V8/ICIQ-SF scores and voiding frequencies recorded in the bladder diary were compared between groups. Results: Four patients in Group-1 and eight in Group-2 left the study without completing the treatment. TTNS was performed in both groups for 12 weeks. There was a significant decrease in the voiding frequency, OAB-V8, ICIQ-SF scores in both group-1 and group-2 (p<0.001). A significant decrease in the OAB-V8 score was observed in the 5th week in Group-1, and on the 3rd week in group-2. Complete response was observed in 6 patients (23.1%) in Group-1 after 12 weeks of TTNS procedure. In group-2, 10 patients (45.5%) had a complete response. After the 12-week TTNS procedure, no significant difference was observed between the groups in terms of treatment response. Conclusion: TTNS can be safely used before invasive treatments in resistant OAB. TTNS procedure three times a week seems more effective than performing it once a week.


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