ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypertension

Beachchair shoulder surgery

Condition category

Condition code

Cardiovascular

Hypertension

Surgery

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]

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]

Mean arterial blood pressure

Timepoint [1]

During surgery mean arterial blood pressure will be taken 5 minutes after anaesthetised patient is placed into beachchair position

Primary outcome [2]

Cerebral oxygen saturation will be measured via forehead optodes connected to a Nonin Equanox cerebral oximeter.

Timepoint [2]

During surgery cerebral oxygen saturation will be taken 5 minutes after anaesthetised patient is placed into beachchair position

Secondary outcome [1]

Left ventricular chamber geometry will be assessed via transthoracic echocardiography using a phased array transducer connected to a Sonosite Micromax ultrasound unit.

Timepoint [1]

During surgery left ventricular geometry will be assessed 5 minutes after anaesthetised patient is placed into beachchair position

Secondary outcome [2]

Left ventricular outflow obstruction will be assessed via transthoracic echocardiography using colour flow flow Doppler examination of the left ventricular outflow tract

Timepoint [2]

During surgery left ventricular outflow tract obstruction will be assessed 5 minutes after anaesthetised patient is placed into beachchair position

Secondary outcome [3]

The administration for vasopressor intervention during episodes of hypotension via direct observation of cumulative drug dose.

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Avenue Private Hospital - Windsor

Recruitment postcode(s) [1]

3181 - Windsor

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Melbourne Orthopaedic Group

Address [1]

30 The Avenue
Windsor
Victoria 3181

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

Grattan St
Parkville
Victoria 3010

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

The Avenue Hospital

Address [1]

33 The Avenue
Windsor
Victoria 3181

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Avenue Hospital Human Research and Ethics Committee

Ethics committee address [1]

The Avenue Hospital 
33 The Avenue 
Windsor 
Victoria 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/03/2015

Approval date [1]

24/10/2015

Ethics approval number [1]

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

A/Prof Paul Soeding

Address

Department Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3010

Country

Australia

Phone

+61 414902753

Fax

[email protected]

Contact person for public queries

Name

Paul Soeding

Address

Department Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3010

Country

Australia

Phone

+61 414902753

Fax

[email protected]

Contact person for scientific queries

Name

Paul Soeding

Address

Department Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3010

Country

Australia

Phone

+61 414902753

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Left Ventricular Hypertrophy in Beach Chair Surgery-an Echocardiography Study of Athletes and Hypertensive Patients.	2020	https://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.

Trial Review

Documents added manually

Documents added automatically