Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV): a multicentre, randomised, controlled clinical trial.

BACKGROUND: It is uncertain whether individualisation of the perioperative open-lung approach (OLA) to ventilation reduces postoperative pulmonary complications in patients undergoing lung resection. We compared a perioperative individualised OLA (iOLA) ventilation strategy with standard lung-protective ventilation in patients undergoing thoracic surgery with one-lung ventilation. METHODS: This multicentre, randomised controlled trial enrolled patients scheduled for open or video-assisted thoracic surgery using one-lung ventilation in 25 participating hospitals in Spain, Italy, Turkey, Egypt, and Ecuador. Eligible adult patients (age ≥18 years) were randomly assigned to receive iOLA or standard lung-protective ventilation. Eligible patients (stratified by centre) were randomly assigned online by local principal investigators, with an allocation ratio of 1:1. Treatment with iOLA included an alveolar recruitment manoeuvre to 40 cm H2O of end-inspiratory pressure followed by individualised positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance, and individualised postoperative respiratory support with high-flow oxygen therapy. Participants allocated to standard lung-protective ventilation received combined intraoperative 4 cm H2O of PEEP and postoperative conventional oxygen therapy. The primary outcome was a composite of severe postoperative pulmonary complications within the first 7 postoperative days, including atelectasis requiring bronchoscopy, severe respiratory failure, contralateral pneumothorax, early extubation failure (rescue with continuous positive airway pressure, non-invasive ventilation, invasive mechanical ventilation, or reintubation), acute respiratory distress syndrome, pulmonary infection, bronchopleural fistula, and pleural empyema. Due to trial setting, data obtained in the operating and postoperative rooms for routine monitoring were not blinded. At 24 h, data were acquired by an investigator blinded to group allocation. All analyses were performed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, NCT03182062, and is complete. FINDINGS: Between Sept 11, 2018, and June 14, 2022, we enrolled 1380 patients, of whom 1308 eligible patients (670 [434 male, 233 female, and three with missing data] assigned to iOLA and 638 [395 male, 237 female, and six with missing data] to standard lung-protective ventilation) were included in the final analysis. The proportion of patients with the composite outcome of severe postoperative pulmonary complications within the first 7 postoperative days was lower in the iOLA group compared with the standard lung-protective ventilation group (40 [6%] vs 97 [15%], relative risk 0·39 [95% CI 0·28 to 0·56]), with an absolute risk difference of -9·23 (95% CI -12·55 to -5·92). Recruitment manoeuvre-related adverse events were reported in five patients. INTERPRETATION: Among patients subjected to lung resection under one-lung ventilation, iOLA was associated with a reduced risk of severe postoperative pulmonary complications when compared with conventional lung-protective ventilation. FUNDING: Instituto de Salud Carlos III and the European Regional Development Funds.

Accuracy and Comprehensiveness in Recording Information of a Web-Based Application for Preoperative Assessment: A Prospective Observational Study.

PURPOSE: Preanestes@s is a web-based application that includes a smart computer-based self-assessment preoperative questionnaire (PreQuest). Preanestes@s enables remote non-telephonic preoperative assessment via a virtual visit. We aimed to determine if the American Society of Anesthesiologists (ASA) physical status classification assigned by PreQuest and virtual visit is comparable with that assigned by face-to-face assessment, and to determine the accuracy of Preanestes@s in recording complementary preoperative information. DESIGN: Prospective, observational, paired study. METHODS: This study was conducted in a tertiary teaching hospital. A total of 510 adult patients scheduled for surgery were consecutively recruited. Of these, 220 patients were included in the analysis of ASA grade agreement. FINDINGS: PreQuest and virtual visit showed higher predictive value than face-to-face assessment in detecting patients with ASA grades 1 to 2. Face-to-face assessment showed the highest rate of false negatives (ASA 3-4 misclassified as ASA 1-2), with a sensitivity of 44.2% versus 69.8% and 50% for PreQuest and virtual visit, respectively. Virtual visit showed the highest agreement with the ASA grade assigned by a panel of experts (kappa index 0.52, 95% confidence interval 0.15-0.89). PreQuest and virtual visit offered a more comprehensive registry of anthropometric data, more detailed record of chronic diseases condition, and more accurate registry of patients' treatments (virtual visit > PreQuest > face-to-face assessment). CONCLUSIONS: The combined use of PreQuest and virtual visit offers a better performance in assigning the ASA grade for non-complex patients and a more accurate and detailed record of complementary information. This finding suggests the feasibility of Preanestes@ as a tool for preoperative assessment.

Influence of the end inspiratory pause on respiratory mechanics and tidal gas distribution of surgical patients ventilated under a tailored open lung approach strategy: A randomised, crossover trial.

BACKGROUND: The effect of modifying the end inspiratory pause (EIP) on respiratory mechanics and gas distribution of surgical patients ventilated with an open lung approach (OLA) has not been addressed before. METHODS: Prospective, randomised, crossover study carried out in a tertiary hospital. Subjects were assigned to receive an initial EIP of 10% or 30% of the total inspiratory time. We compared standard ventilation [time 0: tidal volume (VT) 7 mL × kg-1, respiratory rate (RR) 13, inspiratory:expiratory (I:E) rate 1:2, positive end-expiratory pressure (PEEP) 5 cm H2O and EIP 10% and 30% for groups 1 and 2, respectively) with tailored OLA (similar parameters except for a tailored PEEP after a stepwise recruitment manoeuvre), followed by a crossover assignment sequence between groups (times 2-4). RESULTS: We included 32 adult subjects undergoing major surgery. Tailored OLA strategy was associated with a significant increase in PEEP, plateau pressure (Pplat), PaO2, and compliance of the respiratory system (CRS) with a significant decrease in driving pressure (Pdriv) and PaCO2, and a more homogeneous gas distribution in both groups. A significantly lower PEEP (p < 0.001), Pdriv (5 [5-6] versus 6.5 [6-8] cmH2O; p < 0.001) and mean airway pressure (Pmean; p < 0.001) together with a higher CRS (77 [67-87] versus 58 [52-70] ml*cmH2O-1; p < 0.001) were observed when an EIP of 30% was applied as compared to an EIP of 10%. CONCLUSION: The use of a tailored OLA strategy combined with a longer EIP is associated with a higher CRS, and a lower Pdriv, Pmean and PEEP. Additional studies are necessary to assess if the improved ventilatory conditions observed with a longer EIP are associated with better patients' outcomes. Trial registration at clinicaltrials.gov with identifier: NCT03568786.

A noninvasive postoperative clinical score to identify patients at risk for postoperative pulmonary complications: the Air-Test Score.

BACKGROUND: Postoperative pulmonary complications (PPCs) negatively affect morbidity, healthcare costs and postsurgical survival. Preoperative and intraoperative peripheral oxyhemoglobin saturation (SpO2) levels are independent risk factors for postoperative pulmonary complications (PPCs). The air-test assesses the value of SpO2 while breathing room-air. We aimed at building a clinical score that includes the air-test for predicting the risk for PPCs. METHODS: This is a development and validation study in patients -randomly divided into two cohorts- from a large randomized clinical trial (iPROVE) that enrolled 964 intermediate-to-high risk patients scheduled for abdominal surgery. Arterial oxygenation was assessed on room-air in the preoperative period (preoperative air-test) and 3h after admission to the postoperative care unit (postoperative air-test). The air-test was defined as positive or negative if SpO2 was ≤96% or >96%, respectively. Positive air-tests were stratified into weak (93-96%) or strong (<93%). The primary outcome was a composite of moderate-to-severe PPCs during the first seven postoperative days. RESULTS: A total of 902 patients were included in the final analysis (542 in the development cohort and 360 in the validation cohort). Regression analysis identified five independent risk factors for PPC: age, type of surgery, pre- and postoperative air-test, and atelectasis. The area under the receiver operating characteristic curve (AUC) was 0.79 (95% CI: 0.75-0.82) when including these five independent predictors. We built a simplified score termed "air-test score" by using only the pre- and postoperative SpO2, resulting in an AUC of 0.72 (95% CI: 0.67-0.76) for the derivation and 0.72 (95% CI: 0.66-0.78) for the validation cohort, respectively. The air-test score stratified patients into four levels of risk, with PPCs ranging from <15% to >75%. CONCLUSIONS: The simple, non-invasive and inexpensive bedside air-test score, evaluating pre- and postoperatively SpO2 measured on room-air, helps to predict the risk for PPCs.

Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial.

BACKGROUND: We aimed to examine whether using a high fraction of inspired oxygen (FIO2) in the context of an individualised intra- and postoperative open-lung ventilation approach could decrease surgical site infection (SSI) in patients scheduled for abdominal surgery. METHODS: We performed a multicentre, randomised controlled clinical trial in a network of 21 university hospitals from June 6, 2017 to July 19, 2018. Patients undergoing abdominal surgery were randomly assigned to receive a high (0.80) or conventional (0.3) FIO2 during the intraoperative period and during the first 3 postoperative hours. All patients were mechanically ventilated with an open-lung strategy, which included recruitment manoeuvres and individualised positive end-expiratory pressure for the best respiratory-system compliance, and individualised continuous postoperative airway pressure for adequate peripheral oxyhaemoglobin saturation. The primary outcome was the prevalence of SSI within the first 7 postoperative days. The secondary outcomes were composites of systemic complications, length of intensive care and hospital stay, and 6-month mortality. RESULTS: We enrolled 740 subjects: 371 in the high FIO2 group and 369 in the low FIO2 group. Data from 717 subjects were available for final analysis. The rate of SSI during the first postoperative week did not differ between high (8.9%) and low (9.4%) FIO2 groups (relative risk [RR]: 0.94; 95% confidence interval [CI]: 0.59-1.50; P=0.90]). Secondary outcomes, such as atelectasis (7.7% vs 9.8%; RR: 0.77; 95% CI: 0.48-1.25; P=0.38) and myocardial ischaemia (0.6% [n=2] vs 0% [n=0]; P=0.47) did not differ between groups. CONCLUSIONS: An oxygenation strategy using high FIO2 compared with conventional FIO2 did not reduce postoperative SSIs in abdominal surgery. No differences in secondary outcomes or adverse events were found. CLINICAL TRIAL REGISTRATION: NCT02776046.

Prediction of bilateral cerebral oxygen desaturations from a single sensor in adult cardiac surgery: A prospective observational study.

BACKGROUND: Monitoring regional cerebral oxygen saturation (rcSO2) with near-infrared spectroscopy is increasingly being performed in patients scheduled for cardiac surgery. It is sometimes difficult to monitor both frontal lobes due to anatomical or space compromises. However, it remains unclear whether the use of only one lateral or medial probe can provide adequate bilateral monitoring. OBJECTIVE: To evaluate the efficacy of using a single lateral or medial probe to detect substantial desaturations on both sides. DESIGN: A prospective observational study. SETTING: Tertiary university teaching hospital. PATIENTS: Seventeen adult patients undergoing elective cardiac surgery monitored with three near-infrared spectroscopy probes (two lateral and one medial) using an INVOS 5100C monitor. INTERVENTIONS: The value of rcSO2 was recorded up to 19 times during each procedure. Substantial desaturation was defined as an absolute rcSO2 value of 50% or less or a decrease of more than 20% compared with baseline values on spontaneous ventilation with 21% oxygen. MAIN OUTCOME MEASURES: The level of agreement between the three pairs of probes using the Bland-Altman method for repeated measures, and the grade of concordant and discordant results between the three pairs of probes by means of contingency tables and the κ coefficient. RESULTS: We obtained 244 records per probe. Greater agreement was observed between the two lateral probes (mean ±â€ŠSD of the differences between recordings was -0.9 ±â€Š5.5); mean difference between left and medial, and right and medial probes was 2.4 ±â€Š7.3 and 3.3 ±â€Š6.7, respectively. The rate of discordant results between the two lateral probes was 5.7%, κ coefficient of 0.6 with 95% confidence interval (95% CI 0.4 to 0.8), and between the left and medial, and right and medial of 8.2 and 7.4%, with κ coefficients of 0.57 (95% CI 0.38 to 0.76) and 0.5 (95% CI 0.29 to 0.71), respectively. CONCLUSION: In cardiac surgery patients in whom there is difficulty in accommodating two rcSO2 probes, a single lateral probe can effectively measure bilateral rcSO2 in specific scenarios.

Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial.

BACKGROUND: The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation. METHODS: We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m2. Patients were randomly assigned (1:1:1:1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)-iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA-CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD-CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD-O2 (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923. FINDINGS: Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic complications did not differ for patients in OLA-iCPAP (110 [46%] of 241, relative risk 0·89 [95% CI 0·74-1·07; p=0·25]), OLA-CPAP (111 [47%] of 238, 0·91 [0·76-1·09; p=0·35]), or STD-CPAP groups (118 [48%] of 244, 0·95 [0·80-1·14; p=0·65]) when compared with patients in the STD-O2 group (125 [51%] of 244). Intraoperatively, PEEP was increased in 69 (14%) of patients in the standard perioperative ventilation groups because of hypoxaemia, and no patients from either of the OLA groups required rescue manoeuvres. INTERPRETATION: In patients who have major abdominal surgery, the different perioperative open lung approaches tested in this study did not reduce the risk of postoperative complications when compared with standard lung-protective mechanical ventilation. FUNDING: Instituto de Salud Carlos III of the Spanish Ministry of Economy and Competitiveness, and Grants Programme of the European Society of Anaesthesiology.

Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial.

INTRODUCTION: Surgical site infection (SSI) is a serious postoperative complication that increases morbidity and healthcare costs. SSIs tend to increase as the partial pressure of tissue oxygen decreases: previous trials have focused on trying to reduce them by comparing high versus conventional inspiratory oxygen fractions (FIO2) in the perioperative period but did not use a protocolised ventilatory strategy. The open-lung ventilatory approach restores functional lung volume and improves gas exchange, and therefore it may increase the partial pressure of tissue oxygen for a given FIO2. The trial presented here aims to compare the efficacy of high versus conventional FIO2 in reducing the overall incidence of SSIs in patients by implementing a protocolised and individualised global approach to perioperative open-lung ventilation. METHODS AND ANALYSIS: This is a comparative, prospective, multicentre, randomised and controlled two-arm trial that will include 756 patients scheduled for abdominal surgery. The patients will be randomised into two groups: (1) a high FIO2 group (80% oxygen; FIO2 of 0.80) and (2) a conventional FIO2 group (30% oxygen; FIO2 of 0.30). Each group will be assessed intra- and postoperatively. The primary outcome is the appearance of postoperative SSI complications. Secondary outcomes are the appearance of systemic and pulmonary complications. ETHICS AND DISSEMINATION: The iPROVE-O2 trial has been approved by the Ethics Review Board at the reference centre (the Hospital Clínico Universitario in Valencia). Informed consent will be obtained from all patients before their participation. If the approach using high FIO2 during individualised open-lung ventilation decreases SSIs, use of this method will become standard practice for patients scheduled for future abdominal surgery. Publication of the results is anticipated in early 2019. TRIAL REGISTRATION NUMBER: NCT02776046; Pre-results.

Patient safety under deep sedation for digestive endoscopic procedures.

Deep sedation with Propofol has become popular in recent years. The safety of this technique when administered by non-anaesthesiologists has created much controversy which at times is masked in a contentious debate on the economic sustainability of the health system. In 2011, the Spanish Society of Anaesthesiology, Resuscitation and Pain Therapy, along with 20 other organisations from European countries, revoked the recommendations of the European Society of Gastrointestinal Endoscopy on the administration of Propofol by non-anaesthesiologists, citing that it is "extremely dangerous for the safety and quality of endoscopic procedures". The FDA in 2005 had already rejected the use of Propofol by non-anaesthesiologists in the United States, a prohibition which was reiterated in 2010 and is still in force, basing its evidence, among others, on the recommendations and guidelines of the Joint Commission and the Declaration of Helsinki. In Spain, the data sheet of Propofol restricts the use of the drug to anaesthesiologists and intensivists in intensive care units. In our opinion, the key elements to discuss (which we develop in our paper) are those related to: a) the morbidity and mortality of sedation (which is the same as speaking about the factors that influence its safety); b) the appropriate professionals to use this technique; and c) economic aspects related to the use of said technique. Our conclusion is that a technique cannot be declared safe when a high percentage of patients present with varying respiratory depression (and therefore hypoxaemia) and hypotension. We are confident that the collaboration of the Spanish Society of Digestive Pathology and the Spanish Society of Digestive Endoscopy with the Spanish Society of Anaesthesiology, Resuscitation and Pain Therapy is the first step towards finding a satisfactory solution for everyone, and especially for our patients.

In response to the editorial "Sedation in endoscopy in 2016: Is it safe sedation with propofol led by the endoscopist in complex situations?"

It is universally accepted that deep sedation involves more risks than light-to-moderate sedation. Deep sedation for endoscopic explorations is normally provided by anesthesiologists in Spain and in most countries of the European Unión. The present debate about deep sedation-anesthesia states goes beyond the topic of cardiovascular and respiratory adverse events, and targets the cognitive consequences and global increased mortality of uncontrolled sedation states, especially in specific fragile populations. We consider that strong recomendations for sedative techniques in endoscopic procedures should be made in Spain taking in consideration to two basic principles: 1) according to published evidence concerning patient safety, deep sedation must be an unequivocal responsibility of the anesthesiologist, and 2) we must define which patients are candidates for deep sedation during endoscopic procedures, as this will help to regulate patient flow in clinics and to reduce adverse effects associated with overtreatment of patients.

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

BACKGROUND: Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery. METHODS: This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. DISCUSSION: The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications. TRIAL REGISTRATION: Registered on 5 June 2014 with identification no. NCT02158923 .