Awareness, AnesthesiaDREAMYNCT03100396
Direct REporting of Awareness in MaternitY Patients
An observational study of Awareness, Anesthesia and Obstetric Anesthesia Problems, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Awareness, Anesthesia, Obstetric Anesthesia Problems
- How many people
- 3,100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2017to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing obstetric-indication surgery under general anaesthesia
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Reporting of Awareness in Maternity Patients: a Prospective Evaluation of Accidental Awareness Under General Anaesthesia in Obstetric Surgery Patients
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.
Read the 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.
- Medical subject headings
- Intraoperative Awareness
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of accidental awareness under general anaesthesia
Unintended awareness under general anaesthesia being reported following direct questioning with a Brice questionnaire
Measured: 30 days
Secondary outcomes (5)
Incidence and types of dreams under anaesthesia
Qualitative data on each awareness event; including recall, timing, understanding and emotional response
Measured: 30 days
Incidence of post-traumatic stress disorder (PCL-5 checklist)
Incidence of post-traumatic stress disorder symptoms following awareness events
Measured: 12 months
Predictors of post-traumatic stress disorder based on patient characteristics and type of awareness event
Characteristics associated with post-traumatic stress disorder following anaesthesia with awareness and without awareness
Measured: 12 months
Predictors of awareness based on patient, surgical and anaesthetic characteristics
Modifiable and non-modifiable characteristics associated with awareness
Measured: 12 months
Comparison of direct questioning vs. semi-structured interview schedule approaches to assessing the incidence of awareness
Response from the Brice questionnaire will be assessed against responses gathered in during semi-structured interview schedules
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start22 May 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Awareness, AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter M Odor, Study chair, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100396
- Sponsor's protocol ID
- 16.0063
- Other IDs
- 203113
- Acronym
- DREAMY
- Status last verified
- Jan 2019
- First submitted
- 7 Mar 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32139144
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Reporting of Awareness in Maternity Patients: a Prospective Evaluation of Accidental Awareness Under General Anaesthesia in Obstetric Surgery Patients
- ClinicalTrials.gov ID
- NCT03100396
- Acronym / sponsor ID
- DREAMY / 16.0063
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,100 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing obstetric-indication surgery under general anaesthesia
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of accidental awareness under general anaesthesia
Time frame: 30 days
Unintended awareness under general anaesthesia being reported following direct questioning with a Brice questionnaire
5 secondary outcomes
Incidence and types of dreams under anaesthesia
Time frame: 30 days
Incidence of post-traumatic stress disorder (PCL-5 checklist)
Time frame: 12 months
Predictors of post-traumatic stress disorder based on patient characteristics and type of awareness event
Time frame: 12 months
Predictors of awareness based on patient, surgical and anaesthetic characteristics
Time frame: 12 months
Comparison of direct questioning vs. semi-structured interview schedule approaches to assessing the incidence of awareness
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Derived from this study: PubMed 32139144Odor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Odor study chair
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Awareness, Anesthesia and Obstetric Anesthesia Problems, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of accidental awareness under general anaesthesia (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.