Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001005246
Ethics application status
Approved
Date submitted
5/10/2016
Date registered
14/06/2018
Date last updated
14/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low blood pressure during Beachchair Shoulder Surgery: comparison between patients with and without a history of hypertension
Scientific title
The role of preoperative echocardiography in identifying the risk of hypotension during beachchair surgery.
Secondary ID [1] 290271 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 300505 0
Beachchair shoulder surgery 300506 0
Condition category
Condition code
Cardiovascular 300362 300362 0 0
Hypertension
Surgery 300363 300363 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Echocardiography will be performed before surgery to assess cardiac function, and repeated following beachchair placement after anaesthetic induction. In our experience significant hypotension usually occurs within 5-10minutes following beachchair positioning, Echocardiography is performed at this time to identify changes in cardiac function relating to low blood pressure, and can contribute to vasopressor management. Haemodynamic monitoring is continuous during surgery and management is directed to ensure adequate cerebral perfusion. Repeated examination may be an option in individual patients with protracted hypotension.
Intervention code [1] 296070 0
Diagnosis / Prognosis
Comparator / control treatment
Patients with LVH (Hypertensive patients or athletes with therapy) compared to non-hypertensive patients undergoing beachchair shoulder surgery
Control group
Active

Outcomes
Primary outcome [1] 299818 0
Mean arterial blood pressure
Timepoint [1] 299818 0
During surgery mean arterial blood pressure will be taken 5 minutes after anaesthetised patient is placed into beachchair position
Primary outcome [2] 299819 0
Cerebral oxygen saturation will be measured via forehead optodes connected to a Nonin Equanox cerebral oximeter.
Timepoint [2] 299819 0
During surgery cerebral oxygen saturation will be taken 5 minutes after anaesthetised patient is placed into beachchair position
Secondary outcome [1] 328196 0
Left ventricular chamber geometry will be assessed via transthoracic echocardiography using a phased array transducer connected to a Sonosite Micromax ultrasound unit.
Timepoint [1] 328196 0
During surgery left ventricular geometry will be assessed 5 minutes after anaesthetised patient is placed into beachchair position
Secondary outcome [2] 328197 0
Left ventricular outflow obstruction will be assessed via transthoracic echocardiography using colour flow flow Doppler examination of the left ventricular outflow tract
Timepoint [2] 328197 0
During surgery left ventricular outflow tract obstruction will be assessed 5 minutes after anaesthetised patient is placed into beachchair position
Secondary outcome [3] 328198 0
The administration for vasopressor intervention during episodes of hypotension via direct observation of cumulative drug dose.
Timepoint [3] 328198 0
During surgery the administration of vasopressor for hypotension will be recorded 5 minutes after an anaesthetised patient is placed into beachchair position

Eligibility
Key inclusion criteria
Patients with a history of hypertension with current medication or athletes with history of endurance training scheduled for elective shoulder surgery. An equal number of patients without treatment for hypertension/endurance training will be recruited for comparison.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if there is a history of cerebrovascular event, significant cardiac disease (New York Heart Association symptoms class 3, or pacemaker), carotid endarterectomy, contraindications to interscalene block, or a body mass index (BMI) of >35.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Statistics. Values will be mean (SD). Previous studies have indicated that a 25% decrease in MAP from baseline occurs in most beachchair patients with IPPV on positioning (BJA2013) . However experience has shown us that beachchair positioning results in less MAP decrease when a spontaneous ventilation technique is used (<10%). in patients with LVH we anticipate the decrease in MAP to approach the hypotension seen with relaxant GA (> 20% ) . This is postulated since hypertrophied ventricles are likely to be more susceptible to preload change and reduction in CO with position change. Analysis with G-power indicates a sample number 20 is required to show a clinical difference as demonstrated in the previous study. Students t-test will be used to compare groups. Statistical analysis will be carried out using SPSS software (SPSS, version 19.0, Inc, Chicago, Illinois, USA). A value of p < 0.05 is considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/03/2017
Date of last participant enrolment
Anticipated
Actual
21/03/2017
Date of last data collection
Anticipated
Actual
10/10/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6777 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 14429 0
3181 - Windsor

Funding & Sponsors
Funding source category [1] 294642 0
Other Collaborative groups
Name [1] 294642 0
Melbourne Orthopaedic Group
Country [1] 294642 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan St
Parkville
Victoria 3010
Country
Australia
Secondary sponsor category [1] 293506 0
Hospital
Name [1] 293506 0
The Avenue Hospital
Address [1] 293506 0
33 The Avenue
Windsor
Victoria 3181
Country [1] 293506 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296078 0
The Avenue Hospital Human Research and Ethics Committee
Ethics committee address [1] 296078 0
The Avenue Hospital
33 The Avenue
Windsor
Victoria 3181
Ethics committee country [1] 296078 0
Australia
Date submitted for ethics approval [1] 296078 0
02/03/2015
Approval date [1] 296078 0
24/10/2015
Ethics approval number [1] 296078 0
Trial 186

Summary
Brief summary
During shoulder surgery patients are positioned into an upright sitting position for optimal access to the shoulder joint. In some patients blood pressure may become low during surgery and a concern of the anaesthetist is whether sufficient blood reaches vital organs, including the brain. Chronic disease such as hypertension can alter the size and shape of a patient’s heart, placing them more at risk of low blood pressure during surgery. This study aims to assess the heart with ultrasound before surgery and to further examine the heart during surgery. This examination will enable the anaesthetist to anticipate a major change in blood pressure and treat it effectively. Such information can be used to better protect the patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69474 0
A/Prof Paul Soeding
Address 69474 0
Department Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3010
Country 69474 0
Australia
Phone 69474 0
+61 414902753
Fax 69474 0
Email 69474 0
[email protected]
Contact person for public queries
Name 69475 0
A/Prof Paul Soeding
Address 69475 0
Department Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3010
Country 69475 0
Australia
Phone 69475 0
+61 414902753
Fax 69475 0
Email 69475 0
[email protected]
Contact person for scientific queries
Name 69476 0
A/Prof Paul Soeding
Address 69476 0
Department Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3010
Country 69476 0
Australia
Phone 69476 0
+61 414902753
Fax 69476 0
Email 69476 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLeft Ventricular Hypertrophy in Beach Chair Surgery-an Echocardiography Study of Athletes and Hypertensive Patients.2020https://dx.doi.org/10.1016/j.echo.2020.01.004
N.B. These documents automatically identified may not have been verified by the study sponsor.