Direct REporting of Awareness in MaternitY Patients | NCT03100396

Studies
Direct REporting of Awareness in MaternitY Patients

NCT03100396

Sponsor

St George's, University of London

Status

Unknown status

Last Update Posted

Jan 17, 2019Actual

Enrollment

3,100Actual

Phase

Not provided

Conditions

Awareness, Anesthesia
Obstetric Anesthesia Problems

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
203113	Other Identifier	IRAS ID

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2017Actual

Primary Completion Date

Aug 31, 2018Actual

Completion Date

Aug 31, 2019Estimated

First Submitted Date

Mar 7, 2017

First Submission Date that Met QC Criteria

Mar 28, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2019

Last Update Posted Date

Jan 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Background: The challenges of obstetric general anaesthesia practice - including the use of rapid sequence induction, neuromuscular blockade and short duration between anaesthetic induction and start of surgery - may contribute to a higher risk of awareness under general anaesthesia (AAGA) in these patients. The 2014 Royal College of Anaesthetists/Association of Anaesthetists of Great Britain and Ireland National Audit Project 5 highlighted a higher risk of spontaneously reported AAGA in obstetric patients, but it remains unclear what the full (i.e. non-spontaneously reported) risk is. The aim of DREAMY is to establish the incidence of AAGA following general anaesthesia in obstetric surgery patients.

Methods: A standardised Brice questionnaire will be used to screen for recall of intraoperative events in women meeting the eligibility requirements. Questions asked are:

What is the last thing you remember before going to sleep?
What is the first thing you remember after waking up?
Do you remember anything between going to sleep and waking up?
Did you dream during your procedure?
What was the worst thing about your operation?

The validity of the AAGA incidence will be improved by repetition of the questionnaire on three occasions over thirty days and triangulating using structured follow up interviews in all participants reporting AAGA in questionnaire responses. Participants will be followed up over 12 months and asked for self-reported symptoms of post-traumatic stress disorder (PTSD) using the PCL-5 checklist. The research is being run as a multi-centre, descriptive study over 12 months. General condition and details of the anaesthetic procedure will also be recorded for a logistic regression analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence and types of dreams under anaesthesia	Qualitative data on each awareness event; including recall, timing, understanding and emotional response	30 days
Incidence of post-traumatic stress disorder (PCL-5 checklist)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women undergoing obstetric-indication surgery under general anaesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter M Odor	St George's, University of London	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. George's University Hospital		London		SW17 0QT	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32139144	Derived	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.

ID	Term
D007431	Intraoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms