A randomised controlled feasibility trial of a clinical protocol to manage hypotension during major non-cardiac surgery.

Intra-operative hypotension is a risk factor for postoperative morbidity and mortality. Minimally invasive monitors that derive other haemodynamic parameters, such as stroke volume, may better inform the management of hypotension. As a prelude to a multicentre randomised controlled trial, we conducted a single-centre feasibility trial of a protocol to treat hypotension as informed by minimally invasive haemodynamic monitoring during non-cardiac surgery. We recruited adults aged ≥40 years with cardiovascular risk factors who underwent non-cardiac surgery requiring invasive arterial pressure monitoring. Participants were randomly allocated to usual care, or a clinical protocol informed by an arterial waveform contour analysis monitor. Participants, outcome assessors, clinicians outside operating theatres and analysts were blinded to treatment allocation. Feasibility was evaluated based on: consent rate; recruitment rate; structured feedback from anaesthesia providers; and between-group differences in blood pressure, processes-of-care and outcomes. The consent rate among eligible patients was 33%, with 30 participants randomly allocated to the protocol and 30 to usual care. Anaesthesia providers rated the protocol to be feasible and acceptable. The protocol was associated with reduced fluid balance and hypotension exposure in the peri-operative setting. Postoperative complications included: acute myocardial injury in 18 (30%); acute kidney injury in 17 (28%); and surgical site infection in 7 (12%). The severity of complications was rated as moderate or severe in 25 (42%) participants. In summary, this single-centre study confirmed the feasibility of a multicentre trial to assess the efficacy and safety of a physiologically guided treatment protocol for intra-operative hypotension based on minimally invasive haemodynamic monitors.

Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy.

BACKGROUND: Major surgery such as oesophagectomy requires a postoperative stay in intensive care. Painful stimuli lead to sleep disturbance and impairment in quality of life. The aim of this study was to evaluate the effect of psychological counselling and sleep adjuvant measures on postoperative quality of sleep and quality of life. METHODS: This RCT was performed between January 2013 and October 2015. Patients undergoing oesophagectomy for cancer were randomized into one of four groups receiving: psychological counselling plus sleep adjuvant measures during the ICU stay; psychological counselling alone; sleep adjuvant measures alone during the ICU stay; or standard care. The primary endpoint was impairment in quality of life measured using the European Organisation for Research and Treatment of Cancer C30-QL2 questionnaire between admission for surgery and discharge from hospital. The secondary endpoint was impairment in quality of sleep assessed by means of the Pittsburgh Sleep Quality Index between admission for surgery and hospital discharge. RESULTS: The local ethics committee approved the early termination of the study because of relevant changes in the ICU setting. Some 87 patients were randomized and 74 patients were evaluated in the analysis. Psychological counselling reduced the impairment in quality of life (odds ratio 0·23, 95 per cent c.i. 0·09 to 0·61) and in quality of sleep (odds ratio 0·27, 0·10 to 0·73). CONCLUSION: Perioperative psychological support reduces impairment in quality of life and quality of sleep after oesophagectomy. Registration number: NCT01738620 (http://www.clinicaltrials.gov).

Prospective, randomized comparison of ProSeal and Classic laryngeal mask airways in anaesthetized neonates and infants.

BACKGROUND: When compared with the Classic laryngeal mask airway (cLMA), the recently introduced ProSeal laryngeal mask airway (PLMA) has modified features to produce higher airway seal pressures and enable ventilation in circumstances where the cLMA might fail. The first neonatal size 1 PLMA recently became available. This study was designed to compare the effectiveness of the size 1 cLMA and PLMA during positive pressure ventilation in anesthetized neonates and infants. METHODS: Forty-six consecutive patients undergoing elective cardiac surgical procedures were randomized for initial airway management with the cLMA or PLMA. Insertion time (IT), number of placement attempts, ease of placement, quality of the initial airway, maximum tidal volume (TVmax), and airway pressure at which an audible leak in the mouth (P(leak)) occurred were collected. All data were recorded before performing tracheal intubations. RESULTS: IT and success rate were similar for both LMAs. The initial quality of the airway was significantly better for the PLMA (P<0.05). TVmax and P(leak) were significantly higher for PLMA (77 vs 58 ml, P<0.02 and 29.8 vs 24.4 cm H2O, P<0.02). No adverse events were recorded during the study. CONCLUSIONS: The size 1 PLMA forms a more effective seal than size 1 cLMA in neonates. This might allow the PLMA to be used in those newborn infants requiring high airway pressures for ventilation.

Increasing the number of lungs available for transplantation.

Lung transplantation has become a standard treatment for patients with a broad spectrum of end stage lung diseases. Despite this success, many patients die on the waiting list while waiting for appropriate lungs to become available. This review describes the current strategies aimed at addressing this shortage of lungs, as well as summarizing potential future directions in the field. They include efforts to: 1) increase the number of organ donors by legislative action, and education of the public; 2) optimize the management of deceased, potential organ donors; 3) implement optimal criteria to determine organs suitable for transplantation; 4) use ex vivo reconditioning of lungs; and 5) develop xenotransplantation.

Efficacy of INSURE during nasal CPAP in preterm infants with respiratory distress syndrome.

AIM: INSURE (INtubation, SURfactant, Extubation) is a proven complement of nasal CPAP (nCPAP) for respiratory distress syndrome (RDS) treatment of preterm infants. Early administration is characterized by greater success. We aimed to determine the efficacy and failure or other respiratory outcomes of INSURE administration during nasal continous positive airway pressure (nCPAP) treatment of RDS. METHODS: Among 824 premature infants neonatal intensive care unit (NICU) admitted at Padua University Hospital during 2007-2009, 209 (25.4%) were managed by surfactant replacement (200 mg/kg, Curosurf®) if required >45% oxygen ("rescue" treatment), including 42 (20.1%) during nCPAP. Each premature infant treated with INSURE during nasal CPAP was compared to 2 consecutive control infants treated with surfactant during mechanical ventilation, matched for antenatal steroids, delivery route, gestational age, and sex. RESULTS: Infants with RDS, treated with nCPAP and INSURE-complement (N.=25), were comparable in Apgar score, need of PPV at birth, birth weight, pre-surfactant FiO2 and timing of surfactant replacement to controls. However, nCPAP and INSURE-complement was superior in terms both of oxygenation, evaluated as post-treatment FiO2 (Median, [IQR], 26 [21-40] vs. 21 [21-29]; P=0.03) and (a-A) pO2 (0.48 [0.45-0.60] vs. 0.58 [0.53-0.72]; P=0.03). The improved oxygenation was sustained over the following days. In addition, premature infants treated with nCPAP and INSURE-complement developed less respiratory co-morbidities, including pneumothorax, borncopulmonary disease (BPD), and BPD and death (P=0.04). CONCLUSION: INSURE-complement of nasal CPAP has a superior efficacy in terms of oxygenation improvement, maintenance of optimal oxygenation, and reduction of respiratory comorbidities respect to "rescue" surfactant administration during mechanical ventilation.