Patient-posture and Ileal-intubation during colonoscopy (PIC): a randomized controlled open-label trial.
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ABSTRACT:
SUBMITTER: Ahammed SM
PROVIDER: S-EPMC4423309 | biostudies-other | 2014 Jun
REPOSITORIES: biostudies-other
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Project description:Background: The data on long-term nasotracheal intubation among mechanically ventilated critically ill children is limited. The purpose of this study was to compare the rate of post-extubation airway obstruction (PEAO) with nasotracheal and orotracheal intubation. Methods: This open-label randomized controlled trial was conducted in PICU of a tertiary care and teaching hospital in North India from January-December 2020 involving intubated children aged 3 months-12 years. After written informed consent, children were randomized into nasotracheal and orotracheal intubation groups. Post-extubation, modified Westley's croup score (mWCS) was used at 10-timepoints (0-min, 30 min, 1, 2, 3, 6, 12, 24, 36, and 48-h after extubation) to monitor for PEAO. The primary outcome was the rate of PEAO; and secondary outcomes were time taken for intubation, number of intubation attempts, complications during intubation, unplanned extubation, repeated intubations, tube malposition/displacement, endotracheal tube blockade, ventilator associated pneumonia, skin trauma, extubation failure/re-intubation, duration of PICU stay, and mortality. Results: Seventy children were randomized into nasotracheal (n = 30) and orotracheal (n = 40) groups. Both the groups were similar in baseline characteristics. The rate of PEAO was similar between nasotracheal and orotracheal groups (10 vs. 20%, p = 0.14). The maximum mWCS and mWCS at 10-timepoints were similar in two groups. The time taken for intubation was significantly longer (85 vs. 48 s, p < 0.001) in nasotracheal group, whereas other secondary outcomes were similar in two groups. Conclusion: The rate of PEAO was not different between nasotracheal and orotracheal groups. Clinical Trial Registration:http://ctri.nic.in, Identifier: CTRI/2020/01/022988.
| S-EPMC8481700 | biostudies-literature
Project description:In this randomized clinical trial, we have compared the Shudh™ colon cleanse (SCC) with HalfLytely(®) colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability.Patients were randomized to receive either SCC (n = 65) or HCP (n = 68). All colonoscopies were performed by a single, blinded endoscopist. Colon prep was evaluated on a 5 point grading scale. Statistical non-inferiority was pre-defined as a difference of <15 % in the lower limit of the 95.5 % confidence interval for the treatment difference. Data that were collected include bowel prep score, BPT, adverse events, electrolyte abnormalities and patient acceptability.Bowel preparation efficacy was rated as "successful" for 59/65 (90.7 %) in SCC versus 66/68 (97.1 %) in HCP. This gave a success difference of -6.4 % with a 1-sided 95 % lower confidence limit (LCI) for the difference = -13.3 % (non-inferiority p = 0.25). This difference fell within the predefined limit for non-inferiority. The average BPT for SCC was 1.9 h versus 10.9 in HCP (p < 0.001). No serious adverse events were reported in either group. None of the patients in either group had any clinically significant electrolyte imbalance. Patient ratings for palatability and willingness to repeat were significantly better for SCC (p < 0.05).SCC was found to not be inferior to PEG with regards to the quality of bowel preparation. It is worth highlighting that a major advantage of SCC is shorter BPT.
| S-EPMC3731514 | biostudies-literature
Project description:BackgroundTracheal intubation is a life-saving intervention, and optimizing the patient's head and neck position for the best glottic view is a crucial step that accelerates the procedure. The left head rotation maneuver has been recently described as an innovative alternative to the traditional sniffing position used for tracheal intubation with marked improvement in glottic visualization.ObjectiveThis study compared the glottic view and intubating conditions in the sniffing position versus left head rotation during direct laryngoscopy.MethodsThis randomized, open-label clinical trial enrolled 52 adult patients admitted to Baguio General Hospital and Medical Center from September 2020 to January 2021 for an elective surgical procedure requiring tracheal intubation under general anesthesia. Intubation was done using a 45° left head rotation in the experimental group (n=26), while the control group (n=26) was intubated using the conventional sniffing position. Glottic visualization and intubation difficulty with the two procedures were assessed using the Cormack-Lehane grade and Intubation Difficulty Scale, respectively. Successful intubation is measured by observing a capnographic waveform in the end-tidal CO2 monitor after placement of the endotracheal tube.ResultsThere was no statistically significant difference in the Cormack-Lehane grade, with 85% (n=44) of patients classified under grades 1 (n=11 and n=15) and 2 (n=11 and n=7) in the left head rotation and sniffing position groups, respectively. In addition, there were no statistically significant differences in the Intubation Difficulty Scale scores of patients intubated with left head rotation or sniffing position; 30.7% (n=8) of patients in both groups were easily intubated, while 53.8% (n=14) in left head rotation and 57.6% (n=15) in sniffing position groups were intubated with slight difficulty. Similarly, there were no significant differences between the 2 techniques in any of the 7 parameters of the Intubation Difficulty Scale, although numerically fewer patients required the application of additional lifting force (n=7, 26.9% vs n=11, 42.3%) or laryngeal pressure (n=3, 11.5% vs n=7, 26.9%) when intubated with left head rotation. The intubation success rate with left head rotation was 92.3% versus 100% in the sniffing position, but this difference was not statistically significant.ConclusionsLeft head rotation produces comparable laryngeal exposure and intubation ease to the conventional sniffing position. Therefore, left head rotation may be an alternative for patients who cannot be intubated in the sniffing position, especially in hospitals where advanced techniques such as video laryngoscopes and flexible bronchoscopes are unavailable, as is the case in this study. However, since our sample size was small, studies with a larger study population are warranted to establish the generalizability of our findings. In addition, we observed inadequate familiarity among anesthesiologists with the left head rotation technique, and the intubation success rate may improve as practitioners attain greater technical familiarization.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN)ISRCTN23442026; https://www.isrctn.com/ISRCTN23442026.
| S-EPMC10439464 | biostudies-literature
Project description:This study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n?=?100 women. In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: - 0.32, 95% CI [- 0.43; - 0.21], p?<?0.001, Cohen's d?=?0.86), hot flush frequency (- 1.12 [- 1.81; - 0.43], p?=?0.02, Cohen's d?=?0.51), and improved overall menopause-related quality of life (- 2.53 [- 4.17; - 0.89], p?=?0.02, Cohen's d?=?0.49). Twelve (24%) (vs. three [6%]) patients had 50% lesser hot flushes. Problem rating of hot flushes and subdomains of quality of life did not improve. After four weeks, the OLP group was further divided via randomization to continue or discontinue the treatment. Benefits were maintained at week 8 (log-transformed score: - 0.04 [- 0.06; 0.14], p?=?0.45). There was no difference between taking placebos for 8 or 4 weeks (log-transformed score: 0.04 [- 0.17; 0.25], p?=?0.73). Results indicate that open-label placebos may be an effective, safe alternative for menopausal hot flushes.
| S-EPMC7674475 | biostudies-literature
Project description:To compare magnetic imaging-assisted colonoscopy (MIC) with conventional colonoscopy (CC).Magnetic imaging technology provides a computer-generated image of the shape and position of the colonoscope onto a monitor to give visual guidance to the endoscopist. It is designed to improve colonoscopy performance and tolerability for patients by enabling visualization of loop formation and endoscope position. Recently, a new version of MIC technology was developed for which there are limited data.To evaluate this latest generation of MIC among experienced rather than inexperienced or trainee endoscopists, a prospective randomized trial was performed using only gastroenterologists with therapeutic endoscopy training. Consecutive patients undergoing elective outpatient colonoscopy were randomized to MIC or CC, with patients blinded to their group assignment. Endoscopic procedural metrics and quantities of conscious sedation medications were recorded during the procedures. The procedure was classified as "usual" or "difficult" by the endoscopist at the conclusion of each case based on the need for adjunctive maneuvers to facilitate endoscope advancement. After more than one hour post-procedure, patients completed a 10 cm visual analogue pain scale to reflect the degree of discomfort experienced during their colonoscopy. The primary outcome was patient comfort expressed by the visual analogue pain score. Secondary outcomes consisted of endoscopic procedural metrics as well as a sedation score derived from standardized dose increments of the conscious sedation medications.Two hundred fifty-three patients were randomized and underwent MIC or CC between September 2011 and October 2012. The groups were similar in terms of the indications for colonoscopy and patient characteristics. There were no differences in cecal intubation rates (100% vs 99%), insertion distance-to-cecum (82 cm vs 83 cm), time-to-cecum (6.5 min vs 7.2 min), or polyp detection rate (47% vs 52%) between the MIC and CC groups. The primary outcome of mean pain score (1.0 vs 0.9 out of 10, P = 0.41) did not differ between MIC and CC groups, nor did the mean sedation score (8.2 vs 8.5, P = 0.34). Within the subgroup of cases considered more challenging or difficult, time-to-cecum was significantly faster with MIC compared to CC, 10.1 min vs 13.4 min respectively (P = 0.01). Sensitivity analyses confirmed a similar pattern of overall findings when each endoscopist was considered separately, demonstrating that the mean results for the entire group were not unduly influenced by outlier results from any one endoscopist.Although the latest version of MIC resulted in faster times-to-cecum within a subgroup of more challenging cases, overall it was no better than CC in terms of patient comfort, sedation requirements and endoscopic procedural metrics, when performed in experienced hands.
| S-EPMC4177499 | biostudies-literature
Project description:AimTo study the significance of cap-fitted colonoscopy in improving cecal intubation time and polyp detection rate.MethodsThis study was a prospective randomized controlled trial conducted from March 2008 to February 2009 in a tertiary referral hospital at Sydney. The primary end point was cecal intubation time and the secondary endpoint was polyp detection rate. Consecutive cases of total colonoscopy over a 1-year period were recruited. Randomization into either standard colonoscopy (SC) or cap-assisted colonoscopy (CAC) was performed after consent was obtained. For cases randomized to CAC, one of the three sizes of cap was used: D-201-15004 (with a diameter of 15.3 mm), D-201-14304 (14.6 mm) and D-201-12704 (13.0 mm). All of these caps were produced by Olympus Medical Systems, Japan. Independent predictors for faster cecal time and better polyp detection rate were also determined from this study.ResultsThere were 200 cases in each group. There was no significant difference in terms of demographic characteristics between the two groups. CAC, when compared to the SC group, had no significant difference in terms of cecal intubation rate (96.0% vs 97.0%, P = 0.40) and time (9.94 +/- 7.05 min vs 10.34 +/- 6.82 min, P = 0.21), or polyp detection rate (32.8% vs 31.3%, P = 0.75). On the subgroup analysis, there was no significant difference in terms of cecal intubation time by trainees (88.1% vs 84.8%, P = 0.40), ileal intubation rate (82.5% vs 79.0%, P = 0.38) or total colonoscopy time (23.24 +/- 13.95 min vs 22.56 +/- 9.94 min, P = 0.88). On multivariate analysis, the independent determinants of faster cecal time were consultant-performed procedures (P < 0.001), male patients (P < 0.001), non-usage of hyoscine (P < 0.001) and better bowel preparation (P = 0.01). The determinants of better polyp detection rate were older age (P < 0.001), no history of previous abdominal surgery (P = 0.04), patients not having esophagogastroduodenoscopy in the same setting (P = 0.003), trainee-performed procedures (P = 0.01), usage of hyoscine (P = 0.01) and procedures performed for polyp follow-up (P = 0.01). The limitations of the study were that it was a single-center experience, no blinding was possible, and there were a large number of endoscopists.ConclusionCAC did not significantly different from SC in term of cecal intubation time and polyp detection rate.
| S-EPMC2923764 | biostudies-literature
Project description:BackgroundPlacebos can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of "open-label placebos" (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarly effective when provided remotely, as is sometimes required e.g. in the current COVID-19 pandemic.MethodsIn a randomized-controlled trial, we examined the effects of OLP plus treatment as usual (TAU) compared to TAU alone on symptom reduction in people with allergic rhinitis (N = 54) over the course of two weeks. Due to the COVID-19 pandemic, OLP was provided remotely (i.e. sent via postal service). To investigate the potential influence of the clinical encounter on the effects of OLP, we manipulated the perception of the virtual clinical encounter, both with respect to verbal and nonverbal factors (augmented vs. limited encounter).ResultsThe results of the manipulation check confirmed that the augmented clinical encounter was evaluated more positively than the limited encounter, in terms of perceived warmth of the provider. Participants from all treatment groups showed significant symptom reduction from baseline to two weeks later, but OLP had no incremental effect over TAU. Participants benefitted more from OLP when they did not take any other medication against allergic symptoms than when taking medication on demand. When controlling for baseline symptoms, a significant treatment by encounter interaction was found, pointing to greater symptom improvement in the OLP group when the encounter was augmented, whereas the control group improved more when the encounter was limited.DiscussionThe study demonstrates that providing OLP and enhancing the encounter remotely is possible, but their effectiveness might be lower in comparison to previous studies relying on physical patient-provider interaction. The study raises questions for future research about the potential and challenges of remote placebo studies and virtual clinical encounters. The study has been registered as a clinical trial at ISRCTN (record number: 39018).
| S-EPMC7951912 | biostudies-literature
Project description:The purpose of this 21-day assessor blinded, randomized-controlled trial was to compare an open-label placebo (OLP) to treatment as usual (TAU) for cancer survivors with fatigue. This was followed by an exploratory 21-day study in which TAU participants received OLPs while OLP participants in the main study were followed after discontinuing placebos. Cancer survivors (N = 74) who completed cancer treatment 6 months to 10 years prior to enrollment reporting at least moderate fatigue (i.e., ≥4 on a 0-10 scale) were randomized to OLP or TAU. Those randomized to OLP took 2 placebo pills twice a day for 21 days. Compared to those randomized to TAU, OLP participants reported a 29% improvement in fatigue severity (average difference in the mean change scores (MD) 12.47, 95% CI 3.32, 21.61; P = 0.008), medium effect (d = 0.63), and a 39% improvement in fatigue-disrupted quality of life (MD = 11.76, 95% CI 4.65, 18.86; P = 0.002), a large effect (d = 0.76). TAU participants who elected to try OLP for 21-days after the main study reported reductions in fatigue of a similar magnitude for fatigue severity and fatigue-disrupted quality of life (23% and 35%, respectively). OLP may reduce fatigue symptom severity and fatigue-related quality of life disruption in cancer survivors.
| S-EPMC5807541 | biostudies-literature
Project description:The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm-relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94-1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02-1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57-0.95 and OR = 0.66, 95% CI 0.50-0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.
| S-EPMC8604729 | biostudies-literature
Project description:Objective. This study evaluated the effect of antenatal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). Methods. This was a single-centre, randomized, open-label controlled trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less, were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard antenatal care (intervention arm) or standard care only (control arm). Perinatal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol. The trial is registered with ClinicalTrials.gov (NCT01278329). Results. One hundred and twenty-six newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants of mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82-1.44, P < 0.0001) and habituation (ES 1.05, 95% CI 0.53-1.57, P = 0.0001). Conclusion. Prenatal music exposure to mother significantly and favourably influences neonatal behaviour.
| S-EPMC3299264 | biostudies-literature