Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02248623




Registration number
NCT02248623
Ethics application status
Date submitted
2/09/2014
Date registered
25/09/2014
Date last updated
6/04/2016

Titles & IDs
Public title
Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia
Scientific title
An International Multi-Centre Cohort Study of the Incidence of Anaesthesia Awareness Following Laryngoscopy and Intubation: The CONSciousness, Connectedness and IntraOperative Unresponsiveness Study (ConsCIOUS)
Secondary ID [1] 0 0
ConsCIOUS
Universal Trial Number (UTN)
Trial acronym
ConsCIOUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery
Anaesthesiology 0 0 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of isolated forearm test responsiveness following laryngoscopy and intubation
Timepoint [1] 0 0
The test will occur within one minute of securing the airway (laryngoscopy and intubation).
Secondary outcome [1] 0 0
Incidence of isolated forearm test responsiveness before laryngoscopy and intubation
Timepoint [1] 0 0
The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).
Secondary outcome [2] 0 0
Incidence of anaesthesia awareness with recall
Timepoint [2] 0 0
Within 24 hours of the operation
Secondary outcome [3] 0 0
Patient satisfaction questionnaire
Timepoint [3] 0 0
Within 24 hours of the operation and emergence from anaesthesia

Eligibility
Key inclusion criteria
- Adult patients clinically requiring intubation will be included in this cohort.

- Patients must be able to follow the isolated forearm technique commands when awake and
prior to their operation will be included in this cohort.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to isolated forearm technique test such as unable to have tourniquet
on arm for the isolated forearm technique (e.g. lymphedema or operative site).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
260
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Wisconsin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Groningen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Centre Hospitalier Régional de la Citadelle
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
RWTH Aachen University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Auckland, New Zealand
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Michigan
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Witten/Herdecke
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University College London Hospitals
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience
of surgery is the most secure way to prevent awareness with recall. Fortunately the incidence
of awareness with recall (the patient can spontaneously remember the intraoperative event) is
very rare (0.1-0.2%). However the investigators systematic review suggests that consciousness
of intraoperative events may occur in approximately 37% of patients in experimental studies
(as identified by the validated clinical procedure the isolated forearm test that does not
require postoperative recall of the event). In this international cohort study, recruiting a
minimum sample of 200 patients, the investigators will investigate the incidence of
anaesthesia awareness (as identified by the isolated forearm test) following the induction of
anaesthesia and before surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02248623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert D Sanders, MBBS PhD FRCA
Address 0 0
University of Wisconsin, Madison
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02248623