Grant Archive

In spring 2019, Sedana Medical Research Foundation had its first call for proposals. Since then, many well-written and interesting applications have been submitted.

After independent scientific review by two external reviewers and prioritization by Sedana Medical´s Clinical Development Committee, these research projects have been prioritized for funding.

SMRG 2021 Peter Vernon Van Heerden
Peter Vernon van Heerden, MD PhD & Akiva Nachshon, MD

Comparison of inhaled versus intravenous sedation in a general intensive care unit2021

The study aims to demonstrate that inhaled sedation with isoflurane delivered by the Sedaconda ACD device is safe, cost-effective, and with a lower incidence of delirium, in comparison to the commonly used intravenous sedative agents propofol and midazolam.

The study will be carried out in the General Intensive Care Unit at the Hadassah University Hospital, Jerusalem, and will involve 1000 mechanically ventilated patients in the ICU who will be compared to historical matched controls (3 controls per patient, 3000 in total). During the two years that the study is planned for, inhaled sedation with isoflurane will be introduced as the standard of care for all stable ventilated patients in ICU.

The main outcome measures are duration of mechanical ventilation, ICU length of stay, and cost of all sedative medications administered. Secondary endpoints include mortality, incidence of delirium, vasopressor/inotrope doses, and incidence of renal failure.

SMRG 2021 Guy William Glover Luigi Camporota
Luigi Camporota, MD PhD & Guy William Glover, MBChB FRCA FFICM DICM

Effect of volatile sedation on spontaneous breathing during mechanical ventilation for patients with the Acute Respiratory Distress Syndrome2021

The study aims to compare the effects of inhaled sedation with isoflurane delivered via the Sedaconda ACD to intravenous sedation in patients with acute respiratory distress syndrome (ARDS).

The main outcomes include respiratory drive, inspiratory effort, gas exchange, and ventilation efficiency during pressure support ventilation (PSV) in ARDS. Additional outcomes will evaluate the pharmacokinetics of the inhaled sedative delivery as a function of minute ventilation, dead-space ventilation, CO22 elimination, and lung volume.

The study will involve adult patients with ARDS receiving invasive PSV and sedated with IV analgo-sedation who are anticipated to remain on PSV with a stable Richmond Agitation and Sedation Scale (RASS) for 24h or longer. During 6h, patients will receive inhaled sedation titrated to an equivalent RASS and will be compared, in a cross-over trial design with standard of care IV sedation (propofol and fentanyl). Inhaled sedation may lead to a greater degree of spontaneous breathing. It will be important to understand its impact on respiratory drive and effort in ARDS, as these may vary with the inhaled sedative dose and sedation depth, as well as with physiological and mechanical characteristics of the lung.

SMRG 2020 Dr C Lai Prof Monnet
Dr Christopher Lai, MD, Professor Xavier Monnet, MD, Tài Pham, MD PhD.

Effects of sevoflurane on extravascular lung water and pulmonary vascular permeability in patients with acute respiratory distress syndrome.2020

Patients with ARDS and treated with sevoflurane have reduced lung inflammatory response and improved oxygenation. Preclinical studies of inhaled sedation in experimental ARDS have shown a reduction in lung edema but this has not been studied in humans.

In this study, it is hypothesized that the mechanism behind sevoflurane-mediated improved oxygenation in ARDS is reduced lung edema.

This research project will evaluate the effects of inhaled sedation via the AnaConDa, compared with propofol, on extravascular lung water index (EVLWi) and the pulmonary vascular permeability index (PVPI) in ARDS patients. The aim of the study is to increase the understanding of the lung-protective effects of inhaled sedation in ARDS.

SMRG 2020 Armin Flinspach
Armin Flinspach, MD, Elisabeth Adam, MD.

Volatile short-term sedation in patients undergoing cardiac valve surgery: a prospective randomized controlled trial.2020

Following cardiac surgery, sedatives are routinely administered in the intensive care unit (ICU) to facilitate mechanical ventilation. Due to the advancing age of complex cardiac surgery patients, with an increasing prevalence of liver and kidney dysfunction, the metabolism of intravenous sedatives is in part severely impaired and may lead to oversedation, prolonged mechanical ventilation, delirium, and drug-induced hypotension.

There is increasing data that volatile sedation promotes faster patient awakening and shorter extubation times in the surgical critical care setting. Specifically, (multiple) valve surgery requiring prolonged intervention and time on cardiopulmonary bypass are different from CABG surgery. These variables may lead to different outcomes than in patients following CABG surgery.

The aim of the study is to investigate whether patients undergoing cardiac valve surgery will benefit from the postoperative administration of volatile anesthetics.

SMRG 2020 François Labaste
Francois Labaste, MD, Professor Vincent Miniville, Professor Bertrand Marcheix.

AnaConDa Device in cardiac surgery : an easy solution to achieve total inhalation anesthesia with sevoflurane.2020

Volatile (inhaled) anesthetic agents have cardioprotective effects. Administration before a prolonged cardiac ischaemic episode is known as anaesthetic preconditioning.

Several clinical studies indicate that volatile anesthetics given during cardiac surgery confer myocardial protection and reduce the risk of perioperative myocardial infarction, myocardial dysfunction, and death. Other randomized trials did not confirm the benefit of volatile anesthetics on long-term mortality but in these, inhaled anaesthetics were not given during cardio-pulmonary bypass (CPB) due to a lack of vaporizing methods during CPB.

The research team has found and successfully implemented a method to administer inhaled anaesthetics via the AnaConDa during CPB, enabling total inhaled anesthesia throughout the entire surgical procedure.

The main aim of the trial, comparing total inhaled anesthesia and postoperative sedation with intravenous anesthesia and sedation is to describe the feasibility and the safety of use of the AnaConDa during cardiac surgery with CPB.

SMRG 2019 Foti.Giani
Dr Giuseppe Foti, Associate professor and Director and dr Marco Giani.

Feasibility and safety of inhaled sedation in ECMO patients undergoing ultra-protective low frequency ventilation.2019

This study will investigate inhaled sedation delivered with the AnaConDa in Acute Respiratory Distress Syndrome (ARDS) patients undergoing veno-venous extracorporeal membrane oxygenation with ultra-protective tidal volumes and low-frequency ventilation.

Patients on Extracorporeal membrane oxygenation (ECMO) will receive intravenous sedation and inhaled sedation with sevoflurane in randomized order.

Sedation feasibility and sedation offset will be compared between sedation strategies. While retrospective data are promising, a prospective study would confirm that inhaled anaesthetics, that appear to be lung-protective, may be used in patients normally considered too sick for uptake and elimination via the lungs.

SMRG 2019 Gabriel.Parzy
Dr Gabriel Parzy, Dr Jean-Marie Forel, and Dr Laurent Papazian

Inhaled anaesthetic effects on Mean Pulmonary Arterial Pressure in ARDS patients.2019

The main objective of this research project is to investigate the potential reduction of mean pulmonary arterial pressure (mPAP) during inhaled sedation via the AnaConDa, in moderate or severe ARDS patients.

ARDS is associated with cardiopulmonary complications, including cor pulmonale, and carries a high mortality. While inhaled anaesthetics are known to be vasodilatory in general, potential such effects in ARDS are not well studied previously.

Mechanically ventilated ARDS patients will receive sevoflurane and mPAP will be measured before and one hour after the introduction of low-dose sevoflurane. Reduction of pulmonary pressures with inhaled anaesthetics may potentially improve outcomes in ARDS patients.

SMRG 2019 Schläpfer.Beck.Schimmer
Dr Martin Schläpfer, Privatdozent, and Dr Beatrice Beck-Schimmer, Professor.

Sevoflurane Sedation in COVID-19 ARDS Patients to Reduce Lung Injury: a Randomized Controlled Trial.2019

The purpose of this trial is to study the effect of initial temporary sevoflurane sedation on mortality and persistent organ dysfunction (POD) in survivors at day 28 after ICU admission in the population of patients suffering from COVID-19 ARDS.

The coronavirus disease 19 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is spreading rapidly across Europe. While data from European centers are still missing, several publications from Chinese centers are available.

Respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality and may be caused or exacerbated by a ‘cytokine storm syndrome’.

Recent trials from our group demonstrated that the volatile anaesthetic sevoflurane administered during ventilation of patients has anti-inflammatory properties. Moreover, in in vivo studies, volatile anaesthetics reduce the severity of ARDS compared to intravenous sedation, which has been confirmed in a clinical pilot trial. Attenuating ARDS and thereby improving oxygenation strongly decreases morbidity and mortality of patients.”