Automated control of mechanical ventilation during general anaesthesia: study protocol of a bicentric observational study (AVAS)

INTRODUCTION Automated control of mechanical ventilation during general anaesthesia is not common. A novel system for automated control of most of the ventilator settings was designed and is available on an anaesthesia machine. METHODS AND ANALYSIS The 'Automated control of mechanical ventilation during general anesthesia study' (AVAS) is an international investigator-initiated bicentric observational study designed to examine safety and efficacy of the system during general anaesthesia. The system controls mechanical breathing frequency, inspiratory pressure, pressure support, inspiratory time and trigger sensitivity with the aim to keep a patient stable in user adoptable target zones. Adult patients, who are classified as American Society of Anesthesiologists physical status I, II or III, scheduled for elective surgery of the upper or lower limb or for peripheral vascular surgery in general anaesthesia without any additional regional anaesthesia technique and who gave written consent for study participation are eligible for study inclusion. Primary endpoint of the study is the frequency of specifically defined adverse events. Secondary endpoints are frequency of normoventilation, hypoventilation and hyperventilation, the time period between switch from controlled ventilation to assisted ventilation, achievement of stable assisted ventilation of the patient, proportion of time within the target zone for tidal volume, end-tidal partial pressure of carbon dioxide as individually set up for each patient by the user, frequency of alarms, frequency distribution of tidal volume, inspiratory pressure, inspiration time, expiration time, end-tidal partial pressure of carbon dioxide and the number of re-intubations. ETHICS AND DISSEMINATION AVAS will be the first clinical study investigating a novel automated system for the control of mechanical ventilation on an anaesthesia machine. The study was approved by the ethics committees of both participating study sites. In case that safety and efficacy are acceptable, a randomised controlled trial comparing the novel system with the usual practice may be warranted. TRIAL REGISTRATION DRKS DRKS00011025, registered 12 October 2016; clinicaltrials.gov ID. NCT02644005, registered 30 December 2015.