Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01207154 |
| Other study ID # |
10/H0724/40 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
September 21, 2010 |
| Last updated |
October 11, 2017 |
| Start date |
December 2010 |
| Est. completion date |
October 31, 2012 |
Study information
| Verified date |
May 2013 |
| Source |
Oxford University Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to determine whether or not a device which measures depth of
anaesthesia and sedation can be used to assist in the sedation of patients who must have
breathing tubes positioned in their airways before general anaesthesia
Description:
As part of a general anaesthetic, patients frequently have a breathing tube positioned in
their trachea (windpipe) and this is usually performed after they have gone to sleep. For
some patients however, problems with their mouths or neck may mean it is safer for the tube
to be placed before they are asleep and this is performed with the aid of sedation. The level
of sedation is vital. Patients must be adequately sedated to tolerate instruments in their
airway yet at the same time patients must not be oversedated so that they fall asleep or stop
breathing. Assessments using clinical endpoints of sedation are subjective, vary between
observers and patients and do not prevent episodes of undersedation or oversedation. An
objective measure of sedation depth would facilitate safe awake intubation. Previous studies
demonstrate that commercially available depth of anaesthesia monitors can be used to measure
depth of sedation too. We wish to find out if one such monitor can be used to help achieve
the right level of sedation in patients who must have an awake intubation as part of their
anaesthetic. Depth of sedation guided awake intubation has not been described previously. The
current study would comprise two parts. In the first, we will measure sedation depths
correlating with clinical signs of optimal sedation using propofol and remifentanil in a
cohort of patients requiring awake intubation. In the second part, we will titrate sedation
in a cohort of patients requiring awake intubation to the 25th-75th centile of the values
obtained in the first part and determine the adequacy of the conditions achieved. Patients
who are likely to require an awake fibreoptic intubation will be identified when they attend
for their preadmission assessment. Patients requiring certain surgical procedures, by their
very nature, will have a high chance of being deemed to require an awake intubation on the
day of admission. Such procedures, for example, include (but are not limited to) revision
surgery for patients who have previously undergone Maxillofacial reconstructive surgery and
cervical spine neurosurgery for unstable neck disease. These patients will be given written
information explaining that should they go on to require an awake intubation, they may be
invited to participate in the study. This written material will thus be available to
potential study participants for a period of two to four weeks prior to their admission. On
the day of admission, patients who the anaesthetist decides will require an awake intubation
and who are suitable for inclusion in the study will be approached by one of the researchers
who will offer them the opportunity to be enrolled in the study. Informed consent will be
obtained after patients have had the opportunity to ask any questions about the study. Awake
intubation is associated with specific advantages, disadvantages and risks. Both groups of
patients however will receive the same awake intubation technique as those not participating
in the study. The first part of the study involves only the application of noninvasive
forehead electrodes over and above the treatment patients would receive whether a study
participant or not. In the second part of the study, participants will be sedated initially
by titration to BIS values of depth of sedation to evaluate the usefulness of this
measurement. If at any time, the level of sedation in any patient in this second group is
deemed clinically inappropriate, the situation will be modified according to clinical
criteria. Since clinically guided sedation is the usual standard of care, we feel again that
attachment of the BIS electrodes is the only difference from the usual treatment that
participants will experience. The BIS depth of anaesthesia monitor is CE marked and has been
used safely on 34 million patients worldwide. Reliance on BIS measured depth of anaesthesia
to the exclusion of clinical signs is no guarantee of clinically appropriate anaesthesia and
so the same caveat must be applied to it's use to monitor sedation. In this study, monitoring
of and adjustment of sedation by clinical signs will apply at all times as would occur
without BIS monitoring. There are no risks associated with the use of forehead electrodes per
se. Information will be rendered unidentifiable by not recording any information on data
collection sheets which may identify patients. Data will be recorded on a spreadsheet,
entered on a computer and kept only by the principle investigators.The data forms will be
kept in a locked cupboard. No identifiable patient information will be kept after completion
of the project and no participants will be identifiable from the published results.
