Abstract:
BACKGROUND:Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. METHODS/DESIGN:The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. DISCUSSION:To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.
journal_name
Trialsjournal_title
Trialsauthors
Bluth T,Teichmann R,Kiss T,Bobek I,Canet J,Cinnella G,De Baerdemaeker L,Gregoretti C,Hedenstierna G,Hemmes SN,Hiesmayr M,Hollmann MW,Jaber S,Laffey JG,Licker MJ,Markstaller K,Matot I,Müller G,Mills GH,Mulier JP,Pudoi
10.1186/s13063-017-1929-0subject
Has Abstractpub_date
2017-04-28 00:00:00pages
202issue
1issn
1745-6215pii
10.1186/s13063-017-1929-0journal_volume
18pub_type
杂志文章,多中心研究,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:Endovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1548-1
更新日期:2016-08-24 00:00:00
abstract:BACKGROUND:Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-322
更新日期:2013-10-07 00:00:00
abstract:BACKGROUND:The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporti...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2335-3
更新日期:2017-12-22 00:00:00
abstract:BACKGROUND:Although conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excisi...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2084-3
更新日期:2017-07-26 00:00:00
abstract:BACKGROUND:Osteoarthritis (OA) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs, and preferences into the ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04661-z
更新日期:2020-08-24 00:00:00
abstract:BACKGROUND:Radiation therapy (RT) of bone metastases provides an important treatment approach in palliative care treatment concepts. As a consequence of treatment, the extent of radiation-induced toxicity is a crucial feature with consequences to a patient's quality of life. In this context this study aims at reducing ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-1847-1
更新日期:2017-03-03 00:00:00
abstract:BACKGROUND:People with allergic rhinitis (AR) often seek help from Chinese medicine due to dissatisfaction with conventional treatments. Lung-spleen qi deficiency syndrome (LSQDS) is the most common type of AR, and the Chinese herbal medicine formula bi min fang (BMF) is commonly prescribed for AR patients with LSQDS. ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-3151-0
更新日期:2019-01-18 00:00:00
abstract:BACKGROUND:Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or r...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-104
更新日期:2013-04-22 00:00:00
abstract:BACKGROUND:It is widely agreed that triglyceride (TG)-lowering therapy is imperative in early hypertriglyceridemia-induced acute pancreatitis (HTG-AP). Intravenous insulin with or without heparin, and plasmapheresis are available regimens. However, there is no consensus on first-line therapy. METHODS/DESIGN:The Bi-TPA...
journal_title:Trials
pub_type: 杂志文章,多中心研究
doi:10.1186/s13063-019-3498-x
更新日期:2019-06-18 00:00:00
abstract:BACKGROUND:In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despi...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-43
更新日期:2012-04-27 00:00:00
abstract:BACKGROUND:Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-429
更新日期:2013-12-13 00:00:00
abstract:BACKGROUND:Research involving brain imaging is important for understanding common brain diseases. Study endpoints can include features and measures derived from imaging modalities, providing a benchmark against which other phenotypical data can be assessed. In trials, imaging data provide objective evidence of benefici...
journal_title:Trials
pub_type: 杂志文章,多中心研究
doi:10.1186/s13063-018-3113-6
更新日期:2019-01-07 00:00:00
abstract:BACKGROUND:The lack of approved treatments for the majority of rare diseases is reflective of the unique challenges of orphan drug development. Novel methodologies, including new functionally relevant endpoints, are needed to render the development process more feasible and appropriate for these rare populations and th...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-05009-3
更新日期:2021-01-22 00:00:00
abstract:OBJECTIVES:To assess the effect of prone positioning therapy on intubation rate in awake patients with COVID-19 and acute respiratory failure. TRIAL DESIGN:This is a two-center parallel group, superiority, randomized (1:1 allocation ratio) controlled trial. PARTICIPANTS:All patients admitted to the Hospital Civil de ...
journal_title:Trials
pub_type: 信件,随机对照试验
doi:10.1186/s13063-020-04882-2
更新日期:2020-11-23 00:00:00
abstract:BACKGROUND:Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed ex...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-291
更新日期:2013-09-11 00:00:00
abstract:BACKGROUND:People with severe mental illness (SMI) are two to three times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature mortality. Although lifestyle interventions can support people with SMI to lose weight, some are unable to make the...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3689-5
更新日期:2019-11-20 00:00:00
abstract:BACKGROUND:Although various pancreaticojejunal duct-to-mucosa anastomosis methods have been developed to reduce the postoperative risks of pancreaticoduodenectomy, pancreatic fistula remains the most serious complication with a high incident rate. The aim of this study is to compare the safety and effectiveness of one-...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1517-8
更新日期:2016-08-17 00:00:00
abstract:BACKGROUND:Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0614-4
更新日期:2015-03-20 00:00:00
abstract:BACKGROUND:Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the effica...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3770-0
更新日期:2019-12-16 00:00:00
abstract:BACKGROUND:Hearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2973-0
更新日期:2019-01-25 00:00:00
abstract:BACKGROUND:Delirium prevalence in the intensive care unit (ICU) is high. Numerous psychotropic agents are used to manage delirium in the ICU with limited data regarding their efficacy or harms. METHODS/DESIGN:This is a randomized controlled trial of 428 patients aged 18 and older suffering from delirium and admitted t...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-139
更新日期:2011-06-06 00:00:00
abstract:BACKGROUND:Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0635-z
更新日期:2015-04-02 00:00:00
abstract:BACKGROUND:Recently, clinical observations reported the potential benefit of vagus nerve stimulation (VNS) for pediatric epilepsy. Transcutaneous auricular vagus nerve stimulation (ta-VNS) is a newer non-invasive VNS, making it more accessible for treating pediatric epilepsy, yet there is limited clinical evidence for ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0906-8
更新日期:2015-08-21 00:00:00
abstract:BACKGROUND:Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider...
journal_title:Trials
pub_type: 共识发展会议,杂志文章,多中心研究,评审
doi:10.1186/s13063-017-2098-x
更新日期:2017-08-04 00:00:00
abstract:BACKGROUND:Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty. It was hypothesised that the use of a short-stretch, inelastic compression bandage would reduce knee swelling and improve pain and early function. The aim of this study was to provide preliminary...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1767-5
更新日期:2017-01-09 00:00:00
abstract:BACKGROUND:Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-14-219
更新日期:2013-07-17 00:00:00
abstract:BACKGROUND:This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. METHODS/DESIGN:A multicenter, blinded, randomized controlled trial will be conducted in three hospit...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1315-3
更新日期:2016-04-12 00:00:00
abstract:BACKGROUND:Exercise-based cardiac rehabilitation is a beneficial therapy for patients with chronic heart failure. The delivery of exercise-based cardiac rehabilitation should adopt an evidence-based approach, as well as be culturally appropriate and sensitive to individual needs and preferences. The Baduanjin Eight-Sil...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2531-9
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:Depression occurs in up to 50% of patients after stroke and limits rehabilitation and recovery. Mood disorders are also highly prevalent in carers; their mental health intertwined with the physical and mental wellbeing of the person they are caring for. We argue that working with families, rather than patien...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-105
更新日期:2011-04-30 00:00:00
abstract:BACKGROUND:Patients with type 2 diabetes (T2DM) are at increased risk for macrovascular events as well as for microvascular complications. There is evidence that in patients with coronary artery disease (CAD), about 35 % suffer from manifest T2DM. Early glucose-lowering intervention in subjects with T2DM has been demon...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1627-3
更新日期:2016-10-13 00:00:00