scholarly journals Effects of individualized PEEP obtained by two different titration methods on postoperative atelectasis in obese patients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Qing-Yuan Wang ◽  
Yu-Wei Ji ◽  
Li-Xin An ◽  
Lei Cao ◽  
Fu-Shan Xue
Keyword(s):  
Laparoscopic Surgery ◽  
Controlled Trial ◽  
Oxygenation Index ◽  
Lung Compliance ◽  
High Price ◽  
Obese Patients ◽  
Impedance Tomography ◽  
Pulmonary Atelectasis ◽  
Link Type ◽  
Postoperative Atelectasis

Abstract Background The incidence of postoperative pulmonary complications (PPCs) is higher in obese patients undergoing general anesthesia and mechanical ventilation due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. Individualized positive end-expiratory pressure (iPEEP) along with other lung-protective strategies is effective in alleviating postoperative atelectasis. Here, we compared the best static lung compliance (Cstat) titration of iPEEP with electrical impedance tomography (EIT) titration to observe their effects on postoperative atelectasis in obese patients undergoing laparoscopic surgery. Methods A total number of 140 obese patients with BMI ≥ 32.5kg/m2 undergoing elective laparoscopic gastric volume reduction and at moderate to high risk of developing PPCs will be enrolled and randomized into the optimal static lung compliance-directed iPEEP group and EIT titration iPEEP group. The primary endpoint will be pulmonary atelectasis measured and calculated by EIT immediately after extubation and 2 h after surgery. Secondary endpoints will be intraoperative oxygenation index, organ dysfunction, incidence of PPCs, hospital expenses, and length of hospital stay. Discussion Many iPEEP titration methods effective for normal weight patients may not be appropriate for obese patients. Although EIT-guided iPEEP titration is effective in obese patients, its high price and complexity limit its application in many clinical facilities. This trial will test the efficacy of iPEEP via the optimal static lung compliance-guided titration procedure by comparing it with EIT-guided PEEP titration. The results of this trial will provide a feasible and convenient method for anesthesiologists to set individualized PEEP for obese patients during laparoscopic surgery. Trial registration ClinicalTrials.govChiCTR2000039144. Registered on October 19, 2020

scholarly journals Adding dexmedetomidine to morphine-based analgesia reduces early postoperative nausea in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Huai Jin Li ◽  
Shan Liu ◽  
Zhi Yu Geng ◽  
Xue Ying Li
Keyword(s):  
Laparoscopic Surgery ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
High Risk Patient ◽  
Current Control ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Control Group ◽  
Loading Dose ◽  
Link Type

Abstract Background Few studies have investigated the effect of dexmedetomidine on postoperative nausea and vomiting (PONV) in patients underwent gynecological laparoscopic surgery. We investigated if adding dexmedetomidine to a morphine-based patient-controlled analgesia (PCA) could decrease the incidence of PONV in this high-risk patient population. Methods In this prospective, randomized, double-blind and placebo-controlled study, 122 patients underwent gynecological laparoscopic surgery were assigned into two groups. Patients in the dexmedetomidine group (Group Dex) received a loading dose of dexmedetomidine 0.4 μg/kg before the end of surgery, followed by morphine 0.5 mg/ml plus dexmedetomidine 1 μg/ml for postoperative i.v. PCA. Patients in the control group (Group Ctrl) received normal saline before the end of surgery, followed by morphine 0.5 mg/ml alone for postoperative i.v. PCA. PCA pump was programmed as followed: bolus dose 2 ml, lockout interval 8 min and background infusion at a rate of 1 ml/h. The primary outcome was the incidence of nausea and vomiting within the first postoperative 24 h. Results Although there were no significant differences in regard to the total incidence of PONV (41.0% vs 52.5%, P = 0.204), PONV score, time to first onset of PONV, or the need for rescue antiemetics within the first postoperative 24 h between the two groups, the incidence of nausea and total PONV during the first 2 h period was significantly lower in the Group Dex than in the Group Ctrl (9.8% vs 24.6%, P = 0.031 and 0.031, respectively). More patients in Group Dex were over sedated or had bradycardia during the PACU compared with Group Ctrl (P = 0.040 and 0.036, respectively). Conclusion Our protocol in which dexmedetomidine was administered postoperatively – after a loading dose – to intravenous PCA morphine in patients undergoing gynecological laparoscopic surgery, had only early antiemetic effects, while no clinically meaningful antiemetic effect could be evidenced within the first 24 h after surgery. Trial registration Current control trial registered at Chictr.org.cn: ChiCTR1800017172. Date registered: 07/16/2018.

scholarly journals Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000694
Author(s):  
Gemma Stanford ◽  
Jane C Davies ◽  
Omar Usmani ◽  
Winston Banya ◽  
Susan Charman ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Scientific Conference ◽  
Single Centre ◽  
Impedance Tomography ◽  
Link Type ◽  
Airway Clearance ◽  
Randomised Controlled

IntroductionAirway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.Methods and analysisThis is a single-centre RCT with crossover design. Participants perform MBW, IOS and spirometry, and then are randomised to either rest or supervised ACT lasting 30–60 min. MBW, IOS and spirometry are repeated immediately afterwards. EIT and sputum are collected during rest/ACT. On a separate day, the OMs are performed with the other intervention. Primary endpoint is difference in change in OMs before and after ACT/rest. Sample size was calculated with 80% power and significance of 5% for each OM (target n=64).Ethics and disseminationEthics approval was gained from the London–Chelsea Research Ethics Committee (reference 16/LO/0995, project ID 154635). Dissemination will involve scientific conference presentation and publication in a peer-reviewed journal.Trial registration numbersISRCTN11220163 and NCT02721498.

scholarly journals Cervicovestibular rehabilitation in adult with mild traumatic brain injury: a randomised controlled trial protocol

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Pierre Langevin ◽  
Philippe Fait ◽  
Pierre Frémont ◽  
Jean-Sébastien Roy
Keyword(s):  
Traumatic Brain Injury ◽  
Cervical Spine ◽  
Brain Injury ◽  
Neck Pain ◽  
Mild Traumatic Brain Injury ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Conventional Approach ◽  
Persistent Symptoms ◽  
Link Type

Abstract Background Mild traumatic brain injury (mTBI) is an acknowledged public health problem. Up to 25% of adult with mTBI present persistent symptoms. Headache, dizziness, nausea and neck pain are the most commonly reported symptoms and are frequently associated with cervical spine and vestibular impairments. The most recent international consensus statement (2017 Berlin consensus) recommends the addition of an individualized rehabilitation approach for mTBI with persistent symptoms. The addition of an individualized rehabilitation approach including the evaluation and treatment of cervical and vestibular impairments leading to symptoms such as neck pain, headache and dizziness is, however, recommended based only on limited scientific evidence. The benefit of such intervention should therefore be further investigated. Objective To compare the addition of a 6-week individualized cervicovestibular rehabilitation program to a conventional approach of gradual sub-threshold physical activation (SPA) alone in adults with persistent headache, neck pain and/or dizziness-related following a mTBI on the severity of symptoms and on other indicators of clinical recovery. We hypothesize that such a program will improve all outcomes faster than a conventional approach (between-group differences at 6-week and 12-week). Methods In this single-blind, parallel-group randomized controlled trial, 46 adults with subacute (3 to12 weeks post-injury) persistent mTBI symptoms will be randomly assigned to: 1) a 6-week SPA program or 2) SPA combined with a cervicovestibular rehabilitation program. The cervicovestibular rehabilitation program will include education, cervical spine manual therapy and exercises, vestibular rehabilitation and home exercises. All participants will take part in 4 evaluation sessions (baseline, week 6, 12 and 26) performed by a blinded evaluator. The primary outcome will be the Post-Concussion Symptoms Scale. The secondary outcomes will be time to clearance to return to function, number of recurrent episodes, Global Rating of Change, Numerical Pain Rating Scale, Neck Disability Index, Headache Disability Inventory and Dizziness Handicap Inventory. A 2-way ANOVA and an intention-to-treat analysis will be used. Discussion Controlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness. This RCT will be crucial to guide future clinical management recommendations. Trial registration ClinicalTrials.gov Identifier - NCT03677661, Registered on September, 15th 2018.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

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