scholarly journals Optimal Positive End-Expiratory Pressure Obtained with Titration of Fraction of Inspiratory Oxygen: A Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Lingling Gao ◽  
Li Yang ◽  
Lili Pan ◽  
Yun Cui ◽  
Yandong Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pulse Oximetry ◽  
Arterial Oxygen ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Positive End Expiratory Pressure ◽  
Clinical Trial Registry ◽  
Oxygen Fraction ◽  
Operative Care ◽  
Inspiratory Oxygen

Abstract Background Optimal intraoperative positive end expiratory pressure (PEEP) improves patient outcomes. The pulse-oximetry has been used to determine the lung opening and closing pressures. Therefore, we hypothesized that intraoperative optimal PEEP obtained by titrating inspiratory oxygen fraction (FiO2) guided with pulse-oximetry could improve perioperative oxygenation. Methods Forty-six males undergoing elective robotic assisted laparoscopic prostatectomy were randomly assigned to either optimal PEEP (Group O, n=23) or control with fixed PEEP of 5 cmH2O (Group C, n=23). Optimal PEEP, defined as the PEEP with lowest FiO2 or 0.21 to maintain SpO2≥ 95%, was obtained in both groups after placing the patients in Trendelenburg position and peritoneal insufflation. Patients in Group O maintained the optimal PEEP and in Group C maintained PEEP of 5cmH2O intraoperatively. Both groups were extubated in a sitting position once the extubation criteria met. The primary outcome was the partial arterial oxygen pressure (PaO2)/inspiratory oxygen fraction (FiO2) prior to extubation. Secondary outcome was the incidence of postoperative hypoxemia (SpO2༜92% on room-air after extubation) in post-operative care unit. Results The median optimal PEEP was 16 cm H2O [inter-quartile range, 12-18]. The PaO2/FiO2prior to extubation was significantly higher in Group O than that in Group C (77.0±4.9kPa vs.60.6±5.9kPa, p=0.04); PaO2/FiO2 was also significantly higher in Group O 30minutes after extubation (57.6±1.9 vs. 46.6±1.8kPa, p=0.01). The incidence of hypoxemia on room air in the post-operative care unit was significantly lower in the Group O than in the Group C (1/23, or 4.3% vs. 7/23 or 30.4%, p =0.02). Conclusions Intraoperative optimal PEEP can be achieved by titration of FiO2 guided with SpO2. Maintaining intraoperative optimal PEEP improves intraoperative oxygenation and reduces the incidence of post-operative hypoxemia. Trial registration : Chinese Clinical Trial Registry identifier: ChiCTR2100051010. Prospectively registered on 10 September, 2021

scholarly journals Efficacy of Weikang Pian in Patients with Functional Dyspepsia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Lijing Yan ◽  
Lijin Yu ◽  
Linlin Zhao ◽  
Dongsheng Wang ◽  
Dilan Qin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Gastric Emptying ◽  
Functional Dyspepsia ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Gastric Emptying Rate ◽  
Significant Difference

Background. FD (functional dyspepsia) is a common functional gastrointestinal disorder, which lacks effective and safe treatment. Chinese herbal medicine (CHM) has been applied in FD treatment for thousands of years with satisfactory clinical outcomes. Zhishi is a classical traditional Chinese medicine used to treat FD. Weikang pian (WKP) is made of flavonoids extracted from zhishi which could effectively alleviate the symptoms of FD. This research aimed to assess the efficacy and safety of WKP in FD treatment. Methods. This was a randomized, double-blinded and placebo-controlled clinical trial. The patients were diagnosed as FD according to RomeIII criteria. Then, FD patients were selected and assigned randomly to either WKP or placebo group. The subjects randomly received WKP or placebo for 4 weeks with 4 tablets each time, 3 times daily. The single dyspepsia symptom (SDS) scale and the gastric emptying function were measured before and after the treatment. Moreover, the safety of the trial and patient compliance were evaluated. Results. A total of 60 FD patients were eventually enrolled in the trial, among them 45 patients in the WKP group and 15 patients in the placebo group. The primary outcome was the SDS scale, including assessments of postprandial distension, early satiety, epigastric burning, and pain. The secondary outcome was the gastric emptying function. Compared with the placebo group, the symptoms of FD in the WKP group were relieved after 4 weeks of treatment (P<0.05). Some minor changes appeared in the four groups, but there were no significant differences in gastric emptying parameters of GER (2-hour gastric emptying rate) and GET/2 (gastric semiempty time) (P>0.05). Severe adverse events were absent. The compliance to treatment was 94%–96%, and there was no significant difference between the groups. Conclusion. WKP can relieve FD symptoms to some extent. This trial is registered with Chinese Clinical Trial Registry (ChiCTR): CTR 20132482.

scholarly journals Traditional Chinese Medicine (Xiao Tan San Jie Granule) for Covid-19 Patients in Rehabilitation Stage: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yingshuai Li ◽  
Junwen Han ◽  
ying Zhang ◽  
Ji Wang ◽  
Jiangming He ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Assessment ◽  
Virus Disease ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Tcm Theory

Abstract Background: The Corona Virus Disease 2019 (Covid-19) caused pandemic all over the world. As more and more patients gradually are recovering from Covid-19, they still have some symptoms like short of breath, cough, and phlegm. how to improve their quality of life and shorten the rehabilitation time is still no widely recognized clinical program. In this study, we designed Xiao Tan San Jie (XTSJ) Granule based on traditional Chinese medicine (TCM) theory and assess its efficiency and safety during rehabilitation stage of Covid-19 patients. Method/Design: This study is a 12-week, randomized, double-blinded, controlled, clinical trial that will include 132 Covid-19 patients. Eligible participants will be randomly assigned to XTSJ granule group or placebo group. Participants will receive 28 days treatment. The primary outcome assessment is scores of lung CT scan at week 2 and week 4. The secondary outcome assessment includes pulmonary function test, scores of Visual Analogue Scale (VAS) of Covid-19 symptoms, Scores of Qi Deficiency and Phlegm Stasis syndrome scale, Scores of St. George's Respiratory Questionnaire (SGRQ) at week 2 and week 4. Discussion: In TCM theory XTSJ granule has a regulate effect on respiratory function, lung infection, cough and phlegm which has the potential treatment effect on COVID19 patients. This study will provide initial evidence regarding the efficacy and safety of XTSJ granule for Covid-19 patients in rehabilitation stage. Trial registration: This study was prospectively registered on Chinese Clinical Trial Registry( number: ChiCTR2000031672). Registration date: April 6,2020.

scholarly journals Randomized, double blind, placebo controlled, clinical trial to study co-administration of Ashwagandha on safety, immunogenicity, and protection with COVID-19 vaccine: A Study Protocol

2021 ◽  
Author(s):  
Arvind Chopra ◽  
Preeti Chavan Gautam ◽  
Girish Tillu ◽  
Manjit Saluja ◽  
Swapnil Borse ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dose Schedule ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Power Calculation ◽  
National Guidelines ◽  
Igg Antibody ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
The Government

Introduction The government of India has rolled out COVID-19 vaccine program for individuals who are 18 years of age and above and priority is being given to the elderly, and individuals with morbidity. Oxford-AstraZeneca COVID-19 vaccine (COVISHIELD) is most widely used in India. A large number of Indian people have been consuming various traditional medicines in the hope of better protection against COVID-19 infection. Several studies have reported immunological benefits of Ashwagandha and its potential as vaccine adjuvant. We plan to study co-administration of Ashwagandha with COVISHIELD vaccine on safety, immunogenicity and protection. Methods and analysis We designed a prospective, randomized, double blind, parallel group, placebo controlled, two arm, exploratory study on healthy volunteers receiving the COVISHIELDTM vaccine. In addition to the two dose schedule of COVISHIELD vaccine as per national guidelines, participants will be administered 8gm Ashwagandha or placebo tablets respectively per day. Primary outcome measure is immunogenicity as measured by SARS-CoV-2 spike (S1) and RBD-specific IgG antibody titres. Secondary outcome measures are safety, protective immune response and quality of life measures. Adverse event following immunization will be monitored at each time throughout the study. Participants will be tracked on a daily basis with a user friendly mobile phone application. Following power calculation 600 participants will be recruited per arm to demonstrate superiority by a margin of 7% with 80% power. Study duration is 28 weeks with interim analysis at the end of 12 weeks. Ethics and dissemination Ethical approval was obtained through the Central and institutional Ethics Committees. Participant recruitment is expected to commence by August 2021. Results will be presented in conferences and published in preprint followed by peer-reviewed medical journals. Registration details Clinical Trial Registry India (CTRI) Registration Number: CTRI/2021/06/034496. Date of Registration June 30, 2021.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Muhanad AlHareky ◽  
Jehan AlHumaid ◽  
Sumit Bedi ◽  
Maha El Tantawi ◽  
Mazin AlGahtani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
The United States ◽  
Nerve Fibers ◽  
T Test ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Dental Anesthesia ◽  
Gate Control Theory

Background. The ‘‘gate control’’ theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. Methodology. A total of 51 children aged 5–12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and received maxillary buccal infiltration, by injecting 1.8 ml of 2% lidocaine with 1 : 100,000 adrenaline using topical anesthesia 20% benzocaine gel for 15 seconds, while the other half were in the test group and received the same anesthesia using a commercially available external cold and a vibrating device. A face version of Visual Analogue Scale (VAS) was used as a subjective measure to assess the child’s pain experience. The parents were requested to evaluate the child’s ability to tolerate pain using a behavioral/observational pain scale. Sound, Eyes, and Motor (SEM) scale and Faces, Legs, Activity, Cry, and Consolability (FLACC) scale were used to record the child’s pain as perceived by the external evaluator. T-test or Mann–Whitney U-test was used for scale variables, paired sample T-test or Wilcoxon rank t-test was used for before and after data, and chi-square was used for categorical variable, based on the results of normality test. Results. The results showed a statistically significant reduction in pain after the injection for the test group compared with control using VAS scale (mean = 6.68 (1.09) and 8.42 (0.50); p = 0.001 ) and FLACC scale (mean = 5.92 (1.05) and 8.16 (0.54); p = 0.002 ), but not when using SEM scale (mean 3.22 (0.42) and 4.24 (2.74); p = 0.08 ). Conclusions. Combined external cold and vibrating devices can be an effective alternative in reducing experienced pain and fear in children undergoing infiltration dental anesthesia. This study was registered with clinical trial registry of the United States National Institutes of Health (NIH) at ClinicalTrials.gov (NCT03953001).

scholarly journals The Effect of Medium Chain Triglycerides on Time to Nutritional Ketosis and Symptoms of Keto-Induction in Healthy Adults: A Randomised Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Cliff J. d C. Harvey ◽  
Grant M. Schofield ◽  
Micalla Williden ◽  
Joseph A. McQuillan
Keyword(s):  
Clinical Trial ◽  
Healthy Adults ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Medium Chain Triglycerides ◽  
Clinical Trial Registry ◽  
Medium Chain ◽  
Low Carbohydrate ◽  
Randomised Controlled ◽  
Beta Hydroxybutyrate

Medium chain triglycerides (MCTs) are ketogenic and might reduce adverse effects of keto-induction and improve time to ketosis and the tolerability of very low carbohydrate diets. This study investigates whether MCT supplementation improves time to nutritional ketosis (NK), mood, and symptoms of keto-induction. We compared changes in beta-hydroxybutyrate (BOHB), blood glucose, symptoms of keto-induction, and mood disturbance, in 28 healthy adults prescribed a ketogenic diet, randomised to receive either 30 ml of MCT, or sunflower oil as a control, three times per day, for 20 days. The primary outcome measured was the achievement of NK (≥0.5 mmol·L−1 BOHB). Participants also completed a daily Profile of Mood States and keto-induction symptom questionnaire. MCT resulted in higher BOHB at all time points and faster time to NK, a result that failed to reach significance. Symptoms of keto-induction resulted from both diets, with a greater magnitude in the control group, except for abdominal pain, which occurred with greater frequency and severity in the MCT-supplemented diet. There was a possibly beneficial effect on symptoms by MCT, but the effect on mood was unclear. Based on these results, MCTs increase BOHB compared with LCT and reduce symptoms of keto-induction. It is unclear whether MCTs significantly improve mood or time to NK. The trial was registered by the Australia New Zealand Clinical Trial Registry ACTRN12616001099415.

scholarly journals Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Yu Wang ◽  
Yilei Guo ◽  
Ye Lei ◽  
Shuwei Huang ◽  
Liping Dou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Vascular Complications ◽  
Complementary Therapy ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Type 2 Diabetic

Background: Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of diabetic vascular complications. However, the evidence supporting the efficacy of Tongmai Jiangtang capsules in type 2 diabetic coronary heart disease (T2DM-CHD) remains unclear. Herein, we designed a randomized, parallel-controlled clinical trial to investigate a new complementary therapy for T2DM-CHD patients.Methods: A total of 360 T2DM-CHD subjects (aged 18–75 years) will be randomly assigned to the TJC group or the placebo group at a 2:1 ratio. On the basis of western medicine therapy, all the participants will receive TJC or placebo, orally, three capsules/treatment, three per day for 12 weeks. The primary outcomes will be assessed according to the Canadian Cardiovascular Society (CCS) classification. All statistical analyses will be performed setting a two-sided 0.05 significance level, using SAS 9.4 statistical software.Discussion: The efficacy of TJC for the treatment of T2DM-CHD patients will be evaluated. The study will provide reliable clinical research evidence for application of TJC in treating T2DM-CHD patients.Clinical Trial Registration:https://www.chictr.org.cn/enIndex.aspx, Chinese Clinical Trial Registry ChiCTR2000037491.

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals HEALING RATE IN DIABETIC FOOT ULCERS TREATED WITH BIOMEMBRANE AND HYDROCOLLOID POWDER: RANDOMIZED CLINICAL TRIAL

2021 ◽  
Author(s):  
Manuela de Mendonça Figueirêdo Coelho ◽  
Luciana Catunda Gomes de Menezes ◽  
Shérida Karanini Paz de Oliveira ◽  
Ana Débora Alcantara Coêlho Bonfim ◽  
Viviane Mamede Vasconcelos Cavalcante ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Healing Rate ◽  
Foot Ulcers ◽  
Calotropis Procera ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Clinical Trial Registry ◽  
Experimental Group

Objective: to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

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