Direct REporting of Awareness in MaternitY Patients

NCT03100396 | Unknown DMC

• 2 other identifiers: 16.0063203113
• Study Type: observational
• Target: 3,100
• Locations: 1 country
• Sites: 1

Brief Summary

DREAMY is a prospective, multi-centre observational cohort study using a mixed methods approach to provide quantitative and qualitative data on accidental awareness under general anaesthesia (AAGA) in obstetric surgery patients. Obstetric patients undergoing surgery, such as emergency caesarian section under general anaesthesia, are thought to be at higher risk than any other surgical cohorts for AAGA. Patients recruited to the study will be screened for AAGA using a standardised questionnaire on three occasions over 30 days. Follow up with structured interviews for all AAGA patients will occur over 12 months.

Conditions

Awareness, Anesthesia; Obstetric Anesthesia Problems

Outcome Measures

Primary Outcomes (1)

• Incidence of accidental awareness under general anaesthesia

  Unintended awareness under general anaesthesia being reported following direct questioning with a Brice questionnaire

  30 days

Secondary Outcomes (5)

• Incidence and types of dreams under anaesthesia

  30 days

• Incidence of post-traumatic stress disorder (PCL-5 checklist)

  12 months

• Predictors of post-traumatic stress disorder based on patient characteristics and type of awareness event

  12 months

• Predictors of awareness based on patient, surgical and anaesthetic characteristics

  12 months

• Comparison of direct questioning vs. semi-structured interview schedule approaches to assessing the incidence of awareness

  12 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing obstetric-indication surgery under general anaesthesia

You may qualify if:

• Female adults (≥18 years) of ≥ 24/40 gestation
• Receiving general anaesthesia (de novo or regional anaesthesia converted to GA) for surgery with an obstetric indication (e.g. emergency caesarean section, manual removal of placenta, examination under anaesthesia)

You may not qualify if:

• Patients too unwell or confused to be able to complete the questionnaire
• Patient refusal
• General anaesthesia for non-obstetric indication (e.g. colorectal or orthopaedic surgery in a pregnant patient)
• Surgery ≥48 hours post-partum
• Unable to communicate verbally/in writing in English language

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St. George's University Hospital

London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• Odor PM, Bampoe S, Lucas DN, Moonesinghe SR, Andrade J, Pandit JJ; DREAMY Investigators Group. Protocol for direct reporting of awareness in maternity patients (DREAMY): a prospective, multicentre cohort study of accidental awareness during general anaesthesia. Int J Obstet Anesth. 2020 May;42:47-56. doi: 10.1016/j.ijoa.2020.02.004. Epub 2020 Feb 14.

  PMID: 32139144 DERIVED

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter M Odor

  St George's, University of London

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 4, 2017
• Study Start: May 22, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2019
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)