Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001058864
Ethics application status
Approved
Date submitted
27/09/2012
Date registered
4/10/2012
Date last updated
5/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous versus intermittent noninvasive blood pressure measurement in patients undergoing surgery in the beach-chair position
Scientific title
The influence of the continuous versus intermittent noninvasive blood pressure measurement on hemodynamic stability in patients undergoing surgery in the beach-chair position
Secondary ID [1] 281311 0
Nil
Universal Trial Number (UTN)
U1111-1135-1722
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood pressure measurement 287521 0
hemodynamic stability 287522 0
beach-chair position surgery 287523 0
Condition category
Condition code
Anaesthesiology 287844 287844 0 0
Other anaesthesiology
Surgery 287885 287885 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maintanace of the near-normal pressure values throughout the surgery in beach-chair position (using fluids and vasopressors) with continuous noninvasive measurement of blood pressure obtained by the CNAP device (volume clamp method).
Intervention code [1] 285773 0
Treatment: Devices
Comparator / control treatment
Maintanace of the near-normal pressure values throughout the surgery in beach-chair position (using fluids and vasopressors) with standard intermitent noninvasive measurement of blood pressure. The noninvasive pressure will be measured using upper arm cuff each 3-5min according to procedure and patient status, unlimited number of additional measurements is allowed in case of need.
Control group
Active

Outcomes
Primary outcome [1] 288065 0
Time proportion (out of the anesthesia duration) with pressure outside the near-normal values (patients normal +/- 20%).
Analysis per retrospective off-line analysis of continuous pressure readings: Time duration of periods with systolic pressure above the patients normal + 20% or below the pateints normal - 20% will be sumed up. Proportion of these times to total anesthesia duration will be assessed.
Timepoint [1] 288065 0
Anesthesia duration
Primary outcome [2] 288066 0
Time proportion (out of the anesthesia duration) with hypotension (patients normal - 20%).
Analysis per retrospective off-line analysis of continuous pressure readings: Time duration of periods with systolic pressure below the pateints normal - 20% will be sumed up. Proportion of these times to total anesthesia duration will be assessed.
Timepoint [2] 288066 0
Anesthesia duration
Secondary outcome [1] 299364 0
Number and rate of postoperative complications (infectious and organ complications - based on the list used in the POSSUM scoring system). Minor screened complications incl. postoperative nause and vomiting, anemia requiring transfusion, fever etc. Major complications incl. organ failure, reoperation, surgical site infection, sepsis, pneumonia etc.
Complications will be assessed per daily visits of treating physician (not member of the study team) and summarized before discharge by a blinded study team member.
Timepoint [1] 299364 0
Postoperatively until discharge.
Secondary outcome [2] 299365 0
Difference in the Short Orientation Memory Concentration Test
Timepoint [2] 299365 0
baseline (at preanesthesia visit), 20 + 60 minutes after waking from anesthesia

Eligibility
Key inclusion criteria
Patients undergoing surgery in beach-chair position (throid gland surgery, shoulder surgery/arthroscopy)
General anesthesia
Given and signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
obvious perfusion abnormality on the side of measurement, vascular implants or known neuronal / neuromuscular disease on the side of measurement, peripheral edema

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients undergoing elective surgical procedures in beach-chair position will be deemed eligible for inclusion. During routine preanesthesia visit patients meeting inclusion and exclusion criteria will be informed about the possibility to participate in the study. After inclusion the informed consent will be obtained (and signed). Randomization in 1:1 proportion (stratified thyroid gland surgery / shoulder arthroscopy) will be performed on the OR by the treating anesthesiologist (member of the research team) - sealed envelopes technique. The randomization sheat will be marked by the patients ID and consealed till the data statistical analysis. All other members of the team as well as patient him/herself and other hospital staff will be unaware of the treatment group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sealed envelopes technique with the simple urn randomization method will be used to randomly allocate patients into the continuous and intermitent arm. Equal randomization in proportion 1:1 will be used. Startified in the thyroid gland surgery (20:20) and shoulder arthroscopy (20:20).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Treating anesthesiologist and study nurse will be aware of the treatment group allocation. Other staff as well as the patient will be blinded.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4574 0
Czech Republic
State/province [1] 4574 0

Funding & Sponsors
Funding source category [1] 286065 0
University
Name [1] 286065 0
Charles University Research Fund (project number P36)
Country [1] 286065 0
Czech Republic
Funding source category [2] 286066 0
Commercial sector/Industry
Name [2] 286066 0
CNSystems Medizintechnik AG
Country [2] 286066 0
Austria
Primary sponsor type
University
Name
Dpt. of Anesthesia and Intensive Care of the Faculty of Medicine Plzen - Charles University Prague
Address
The University hospital and The Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Country
Czech Republic
Secondary sponsor category [1] 284883 0
Individual
Name [1] 284883 0
Jan Benes, MD
Address [1] 284883 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Country [1] 284883 0
Czech Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288117 0
Local ethics committee of the Charles University hospital in Plzen
Ethics committee address [1] 288117 0
Charles University hospital in Plzen
E.Benese 13
Plzen
305 99
Ethics committee country [1] 288117 0
Czech Republic
Date submitted for ethics approval [1] 288117 0
Approval date [1] 288117 0
03/05/2012
Ethics approval number [1] 288117 0

Summary
Brief summary
Aim of the study is to evaluate the safety and efficacy of the use of a completly noninvasive device enabling the continuous measurement of blood pressure in patients with increased risk of cerebral malperfusion due to position changes (beach-chair position) under general anesthesia in compariosn to the standard anesthesia care. As a measure of safety/eficacy the proportion of time outside the near-normal ranges of blood pressures and hypotensive periods will be used in combination with assesment of mental abilities derrangements in the early postoperative course and potential postoperative morbidity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34765 0
Address 34765 0
Country 34765 0
Phone 34765 0
Fax 34765 0
Email 34765 0
Contact person for public queries
Name 18012 0
Jan Benes MD
Address 18012 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Country 18012 0
Czech Republic
Phone 18012 0
+420377104381
Fax 18012 0
Email 18012 0
[email protected]
Contact person for scientific queries
Name 8940 0
Assoc.Prof. Eduard Kasal MD, CSc
Address 8940 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Country 8940 0
Czech Republic
Phone 8940 0
+420377104380
Fax 8940 0
Email 8940 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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