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Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial.

ABSTRACT: BACKGROUND:Postoperative pulmonary complications (PPCs) are major causes of morbidity, mortality, and prolonged hospital stay in patients after surgery. Using effective strategies to prevent its occurrence is essential to improve outcome. However, despite various efforts, the incidence of PPCs remains elevated in high-risk patients. Anticholinergic inhalation is used to reduce high airway resistance and improve pulmonary function; it may be helpful to decrease the risk of PPCs. Penehyclidine is a long-acting anticholinergic agent which selectively blocks M1 and M3 receptors. We hypothesize that, in high-risk patients, prophylactic penehyclidine inhalation may decrease the incidence of PPCs. METHODS:This is a randomized, double-blind, placebo-controlled trial with two parallel arms. A total of 864 patients at high risk of PPCs will be enrolled and randomized to receive prophylactic inhalation of either penehyclidine or placebo (water for injection). Study drug inhalation will be administered from the night (7 pm) before surgery until the second day after surgery, in an interval of every 12 hours. The primary outcome is the incidence of PPCs within 30 days after surgery. Secondary outcomes include the time to onset of PPCs (from end of surgery to first diagnosis of PPCs), the number of PPCs (indicates the number of diagnosed individual PPCs), the incidence of postoperative extrapulmonary complications, the length of stay in hospital after surgery, and the 30-day all-cause mortality. DISCUSSION:Results of the present study will provide evidence to guide clinical practice in using prophylactic inhalation of an anticholinergic to prevent PPCs in high-risk patients. TRIAL REGISTRATION:The study was registered prospectively in Chinese Clinical Trial Registry ( www.chictr.org.cn , ChiCTR-IPC-15006603 ) on 14 May 2015 and retrospectively in ClinicalTrials.gov ( NCT02644876 ) on 30 December 2015.

SUBMITTER: Yan T

PROVIDER: S-EPMC5706155 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial.

Yan Ting T Liang Xin-Quan XQ Wang Tong T Li Wei-Ou WO Li Hui-Juan HJ Zhu Sai-Nan SN Wang Dong-Xin DX

Trials 20171128 1

<h4>Background</h4>Postoperative pulmonary complications (PPCs) are major causes of morbidity, mortality, and prolonged hospital stay in patients after surgery. Using effective strategies to prevent its occurrence is essential to improve outcome. However, despite various efforts, the incidence of PPCs remains elevated in high-risk patients. Anticholinergic inhalation is used to reduce high airway resistance and improve pulmonary function; it may be helpful to decrease the risk of PPCs. Penehycli ...[more]

PMID: 29183393

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Project description:BackgroundPatients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung-protective mechanical ventilation with the use of low tidal volumes, a moderate level of positive end-expiratory pressure (PEEP) and regular alveolar recruitment maneuvers during general anesthesia, even in patients with healthy lungs. The purpose of this clinical trial is to evaluate the effects of intraoperative lung-protective mechanical ventilation, using individualized PEEP values, on postoperative pulmonary complications and the inflammatory response.Methods/designA total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into a study (SG) and a control group (CG). Standard lung-protective ventilation with a PEEP of 6 cmH2O will be applied in the CG and an optimal PEEP value determined during a static pulmonary compliance (Cstat)-directed PEEP titration procedure will be used in the SG. Low tidal volumes (6 mL/Kg ideal bodyweight) and a fraction of inspired oxygen of 0.5 will be applied in both groups. After surgery both groups will receive standard postoperative management. Primary endpoints are postoperative pulmonary complications and serum procalcitonin kinetics during and after surgery until the third postoperative day. Secondary and tertiary endpoints will be: organ dysfunction as monitored by the Sequential Organ Failure Assessment Score, in-hospital stay, 28-day and in-hospital mortality.DiscussionThis trial will assess the possible benefits or disadvantages of an individualized lung-protective mechanical ventilation strategy during open radical cystectomy and urinary diversion regarding postoperative pulmonary complications and the inflammatory response.Trial registrationClinicalTrials.gov, ID: NCT02931409 . Registered on 5 October 2016.

Project description:BackgroundDelirium is associated with a significantly increased risk of postoperative morbidity and mortality. Furthermore, delirium has been associated with an increased risk of prolonged cognitive deficits and accelerated long-term cognitive decline. To date, experimental interventions for delirium have mainly focused on alternative pharmacologic and behavioral strategies in the postoperative period. Few studies have examined whether proactive strategies started before surgery can prevent delirium or reduce its sequelae. Neurocognitive training programs such as Lumosity have been shown to be effective in increasing cognitive performance in both elderly healthy volunteers and patients suffering from a myriad of acute and chronic medical conditions. When initiated in the preoperative period, such training programs may serve as interesting and novel patient-led interventions for the prevention of delirium and postoperative cognitive decline (POCD). We hypothesize that perioperative neurocognitive training is feasible in the older cardiac surgical population and are testing this hypothesis using a randomized controlled design.MethodsThe Prevention of Early Postoperative Decline (PEaPoD) study is a randomized, controlled trial with a target enrollment of 45 elderly cardiac surgical patients. Subjects will be randomized in a 1:1 ratio to undergo either at least 10 days of preoperative neurocognitive training, continued for 4 weeks postoperatively, or usual care control. The primary outcome, feasibility, will be assessed by study recruitment and adherence to protocol. Secondary outcomes will include potential differences in the incidence of postoperative in-hospital delirium and POCD up to 6 months, as determined by the Confusion Assessment Method and the Montreal Cognitive Assessment.DiscussionPEaPoD will be the first trial investigating the use of perioperative cognitive training to potentially reduce delirium and POCD in the cardiac surgical population. Information gleaned from this feasibility study will prove valuable in designing future efficacy studies aimed at determining whether this low-risk, patient-led intervention can reduce serious postoperative morbidity.Trial registrationClinicalTrials.gov, NCT02908464 . Registered on 21 September 2016.

Project description:BackgroundEsophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design.Methods/designThe effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function.DiscussionThe PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.Trial registrationNCT01893008.

Project description:OBJECTIVE:To identify, appraise, and synthesise the best available evidence on the efficacy of perioperative interventions to reduce postoperative pulmonary complications (PPCs) in adult patients undergoing non-cardiac surgery. DESIGN:Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES:Medline, Embase, CINHAL, and CENTRAL from January 1990 to December 2017. ELIGIBILITY CRITERIA:Randomised controlled trials investigating short term, protocolised medical interventions conducted before, during, or after non-cardiac surgery were included. Trials with clinical diagnostic criteria for PPC outcomes were included. Studies of surgical technique or physiological or biochemical outcomes were excluded. DATA EXTRACTION AND SYNTHESIS:Reviewers independently identified studies, extracted data, and assessed the quality of evidence. Meta-analyses were conducted to calculate risk ratios with 95% confidence intervals. Quality of evidence was summarised in accordance with GRADE methods. The primary outcome was the incidence of PPCs. Secondary outcomes were respiratory infection, atelectasis, length of hospital stay, and mortality. Trial sequential analysis was used to investigate the reliability and conclusiveness of available evidence. Adverse effects of interventions were not measured or compared. RESULTS:117 trials enrolled 21?940 participants, investigating 11 categories of intervention. 95 randomised controlled trials enrolling 18?062 participants were included in meta-analysis; 22 trials were excluded from meta-analysis because the interventions were not sufficiently similar to be pooled. No high quality evidence was found for interventions to reduce the primary outcome (incidence of PPCs). Seven interventions had low or moderate quality evidence with confidence intervals indicating a probable reduction in PPCs: enhanced recovery pathways (risk ratio 0.35, 95% confidence interval 0.21 to 0.58), prophylactic mucolytics (0.40, 0.23 to 0.67), postoperative continuous positive airway pressure ventilation (0.49, 0.24 to 0.99), lung protective intraoperative ventilation (0.52, 0.30 to 0.88), prophylactic respiratory physiotherapy (0.55, 0.32 to 0.93), epidural analgesia (0.77, 0.65 to 0.92), and goal directed haemodynamic therapy (0.87, 0.77 to 0.98). Moderate quality evidence showed no benefit for incentive spirometry in preventing PPCs. Trial sequential analysis adjustment confidently supported a relative risk reduction of 25% in PPCs for prophylactic respiratory physiotherapy, epidural analgesia, enhanced recovery pathways, and goal directed haemodynamic therapies. Insufficient data were available to support or refute equivalent relative risk reductions for other interventions. CONCLUSIONS:Predominantly low quality evidence favours multiple perioperative PPC reduction strategies. Clinicians may choose to reassess their perioperative care pathways, but the results indicate that new trials with a low risk of bias are needed to obtain conclusive evidence of efficacy for many of these interventions. STUDY REGISTRATION:Prospero CRD42016035662.

Project description:ObjectivesThe effect of one-lung ventilation (OLV) strategy based on low tidal volume (TV), application of positive end-expiratory pressure (PEEP), and alveolar recruitment maneuvers (ARM) to reduce postoperative acute respiratory distress syndrome (ARDS) and pulmonary complications (PPCs) compared with higher TV without PEEP and ARM strategy in adult patients undergoing lobectomy or pneumonectomy has not been well established.DesignMulticenter, randomized, single-blind, controlled trial.SettingSixteen Italian hospitals.ParticipantsA total of 880 patients undergoing elective major lung resection.InterventionsPatients were randomized to receive lower tidal volume (LTV group: 4 mL/kg predicted body weight, PEEP of 5 cmH2O, and ARMs) or higher tidal volume (HTL group: 6 mL/kg predicted body weight, no PEEP, and no ARMs). After OLV, until extubation, both groups were ventilated using a tidal volume of 8 mL/kg and a PEEP value of 5 cmH2O. The primary outcome was the incidence of in-hospital ARDS. Secondary outcomes were the in-hospital rate of PPCs, major cardiovascular events, unplanned intensive care unit (ICU) admission, in-hospital mortality, ICU length of stay, and in-hospital length of stay.Measurements and main resultsARDS occurred in 3 of 438 patients (0.7%, 95% CI 0.1-2.0) and in 1 of 442 patients (0.2%, 95% CI 0-1.4) in the LTV and HTV group, respectively (Risk ratio: 3.03 95% CI 0.32-29, p = 0.372). Pulmonary complications occurred in 125 of 438 patients (28.5%, 95% CI 24.5-32.9) and in 136 of 442 patients (30.8%, 95% CI 26.6-35.2) in the LTV and HTV group, respectively (risk ratio: 0.93, 95% CI 0.76-1.14, p = 0.507). The incidence of major complications, in-hospital mortality, and unplanned ICU admission, ICU and in-hospital length of stay were comparable in both groups.ConclusionsIn conclusion, among adult patients undergoing elective lung resection, an OLV with lower tidal volume, PEEP 5 cmH2O, and ARMs and a higher tidal volume strategy resulted in low ARDS incidence and comparable postoperative complications, in-hospital length of stay, and mortality.

Project description:ObjectiveTo compare the effectiveness of different oral antibiotics for prevention of dry socket and infection in adults following the surgical extraction of teeth under LA.MethodsThis randomized controlled study was conducted from 10 September 2020 until 10 May 2021. Forty-six patients were randomly allocated to three groups. Sixteen patients were in the postoperative co-amoxiclav (625 mg) group, fifteen in the preoperative co-amoxiclav (625 mg) plus postoperative metronidazole (500 mg) group and fifteen in the preoperative co-amoxiclav (625 mg) plus postoperative amoxicillin (500 mg) group. Evaluation of the postoperative signs of alveolar osteitis and infection was made by a dental surgeon five days postoperatively. Evaluation of the post-surgical extraction pain was made by patients immediately and five days postoperatively on standard 100 mm visual analogue scales (VAS). Furthermore, difficulty of surgery was recorded for all patients immediately postoperatively using (VAS).Resultsall antibiotics used in this study were effective. Only 15% of patients had painful alveolar osteitis and 2% had oral infections. There was no significant decrease in the number of patients with severe alveolar osteitis or infection for co-amoxiclav plus metronidazole and co-amoxiclav plus amoxicillin groups compared to co-amoxiclav group at 5 days post-operation (p-values: 0.715, 0.819 & 0.309). Clinically, metronidazole was more effective in protecting the extracted tooth socket from alveolar osteitis compared to co-amoxiclav and amoxicillin. Moreover, there were significant decreases in mean pain scores at 5 days post-operation compared with the levels of pain immediately after surgery (p-value: 0.001).ConclusionsAdministration of a single preoperative dose of co-amoxiclav with a full postoperative dose of amoxicillin or metronidazole was more effective than conventional treatment with postoperative co-amoxilcalv in reducing the incidence of both alveolar osteitis and infection after surgical extractions. However, these differences were not statistically significant. Interestingly, patients in metronidazole group had the lowest incidence of dry socket.

Project description:BACKGROUND:Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an ?2-adrenoreceptor agonist, has been proven having lung protection effects. However, since now, there has not been final conclusion about whether DEX can reduce the incidence of PPCs. We hypothesize that, in oral and maxillofacial surgery with fibular free flap reconstruction patients, DEX may decrease the incidence of PPCs. METHODS:This was a prospective, double-blind, randomized, placebo-controlled, single-centered trial with two parallel arms. A total of 160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy were enrolled and randomized to receive continuous infusion of either DEX or placebo (normal saline). 0.4 ?g/kg of DEX was given over 10mins as an initial dose followed by a maintaining dose of 0.4 ?g/kg/h till the second day morning after surgery. At the same time, the normal saline was administered a similar quantity. The primary outcome was the incidence of PPCs according to Clavien-Dindo score within 7?days after surgery. RESULTS:The two groups had similar characteristics at baseline. 18(22.5%) of 80 patients administered DEX, and 32(40.0%) of 80 patient administered placebo experienced PPCs within the first 7?days after surgery (relative risk [RR] 0.563,95% confidence interval [CI] 0.346-0.916; P?=?0.017). In the first 7?days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P?=?0.019), and was less prone to occur PPCs (Cox regression, P?=?0.025, HR?=?0.516). When the total dose of DEX was more than 328??g, the patients were unlikely to have PPCs (ROC curve, AUC?=?0.614, P?=?0.009). CONCLUSIONS:For patients undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy who were at intermediate or high risk of developing PPCs, continuous infusion of DEX could decrease the occurrence of PPCs during the first 7?days after surgery and shorten the length of hospital stay after surgery, but did not increase the prevalence of bradycardia or hypotension. TRIAL REGISTRATION:Chinese Clinical Trial Registry, www.chictr.org.cn, number: ChiCTR1800016153; Registered on May 15, 2018.

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Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial.

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Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial.

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