Protocol for direct reporting of awareness in maternity patients (DREAMY): a prospective, multicentre cohort study of accidental awareness during general anaesthesia.

International Journal of Obstetric Anesthesia
P M OdorDREAMY Investigators Group

Abstract

Accidental awareness during general anaesthesia (AAGA) is a complex and rare outcome to investigate in surgical patient populations, particularly obstetric patients. We report the protocol of the Direct Reporting of Awareness in Maternity patients (DREAMY) study, illustrating how the research was designed to address practical and methodological challenges for investigating AAGA in an obstetric cohort. This is the trial protocol of a prospective, multicentre cohort study of patients undergoing obstetric surgery under general anaesthesia. Accidental awareness during general anaesthesia will be detected using three repetitions of standardised direct questioning over 30 days, with responses indicating memories during general anaesthesia verified using structured interviews. Reports will be adjudicated, then classified, in accordance with pre-defined and pre-validated structures, including the Michigan Awareness Classification tool. Quantitative data will be collected on general anaesthesia conduct for all participants. This descriptive study is being conducted in England and aims to recruit a minimum of 2015 patients. The DREAMY study was prospectively registered (ClinicalTrials.gov Identifier: NCT03100396) and ethical approval gra...Continue Reading

Associated Clinical Trials

Citations

Jun 26, 2020·Anthropology & Medicine·E J SoboCorliss D Heath
Sep 23, 2020·Anaesthesia·P M OdorUNKNOWN Pan-London Perioperative Audit and Research Network (PLAN), for the DREAMY Investigators Group
Jan 13, 2021·Anaesthesia·P M OdorUNKNOWN Pan-London Peri-operative Audit and Research Network (PLAN), for the DREAMY Investigators Group
Mar 2, 2021·Current Anesthesiology Reports·Laurence RingCarlos Delgado

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