ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000674235

Ethics application status

Approved

Date submitted

19/04/2018

Date registered

24/04/2018

Date last updated

18/09/2019

Date data sharing statement initially provided

18/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Airway collapsibility as an indicator of perioperative adverse event risk and obstructive sleep apnoea

Scientific title

Airway collapsibility as an indicator of perioperative adverse event risk and obstructive sleep apnoea

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

obstructive sleep apnoea

Airway Collapsibility

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This project assesses upper airway collapsibility and peri- and post-operative adverse events in patients undergoing surgery not related to the head, neck, airways or chest. Demographic and anthropometric (height, weight, neck circumference, Mallampati) information will be recorded and a STOP-Bang assessment performed prior to surgery in all consenting patients. Following surgery, prior to transfer to the recovery room, assessment of airway collapsibility will be performed using the Pclose technique. In addition, all adverse events including respiratory adverse events (respiratory depression (rate & depth), desaturation events, requirement for re-intubation or other medical intervention including unplanned initiation of positive airway pressure therapy) will be documented as well as length of stay in hospital and planned and unplanned intensive care unit or high dependency unit admissions. Within 3 weeks of surgery, sleep apnoea severity will be ascertained in a subgroup of consenting participants using a reliable home monitoring device (ApneaLink) for one night.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Airway collapsibility as assessed by the P Close technique.
Following removal of the laryngeal mask airway, a single use anaesthetic mask with good seal to the patient’s face will be fitted. A flow (pneumotachograph) and pressure sensor (Pmask) and balloon valve capable of completely occluding airflow through the mask will also be connected. Following a period of stable breathing (minimum 5 breaths), complete occlusion will be applied at end expiration resulting in obstructive inspiratory airflow and a progressive increase in inspiratory effort with successive efforts. Each increased effort produces a more negative Pmask until Pclose is reached and Pmask plateaus. The occlusion will be held for a maximum of 5-6 breaths and the results are highly reproducible. Two occlusions will be performed and the mean Pclose calculated. If the two measures differ by more than 10% then a third occlusion will be performed and the closest two measures will be averaged. All assessments will be performed with the patient in the supine position and head neutral.

Timepoint [1]

In theatre

Primary outcome [2]

Planned and unplanned intensive care unit or high dependency unit admissions. This is a composite measure and will be obtained from their medical records.

Timepoint [2]

within the 24h post-surgery

Primary outcome [3]

Mean 24hr oxygen saturation (Nonin WristOx)

Timepoint [3]

within the 24hr post-surgery

Secondary outcome [1]

Severity of obstructive sleep apnoea (AHI) as measured by ApneaLink (Resmed)

Timepoint [1]

One night of at home monitoring to occur within 3 weeks of surgery

Secondary outcome [2]

Respiratory depression (rate & depth). This will be assessed visually by the medical staff during their routine observations during the 24h period post-surgery.

Timepoint [2]

within the 24h post-surgery

Secondary outcome [3]

Requirement for re-intubation or other medical intervention including unplanned initiation of positive airway pressure therapy. This information will be obtained from their medical records.

Timepoint [3]

within the 24h post-surgery

Secondary outcome [4]

length of stay in hospital

Timepoint [4]

within the 24h post-surgery

Eligibility

Key inclusion criteria

Patients undergoing surgery not related to head, neck, airways or chest and able to give consent.

Minimum age

18 Years

Maximum age

69 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients less than 18 years old or 70 years and over
Patients undergoing surgery related to the head, neck, airways or chest
Patients who require intubation
Patients with unstable cardiovascular disease
Those unable to speak English
Pregnant or lactating females

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

To identify a 3±3 cmH2O difference in Pclose between those patients who experience and an adverse event or unplanned transfer (with a at 0.05 and ß at 0.8), assuming a rate of unplanned transfer to ICU or HDU of 5% (based on data from Kaw et al.) 179 patients will need to be studied (170 in non-transfer group, 9 in transfer group). To establish a correlation of 0.4 between OSA severity determined from ApneaLink and Pclose (with a at 0.05 and ß at 0.8) we will need to study of subgroup of 37 people with ApneaLink. To allow for dropout and study failures 200 participants will be recruited for Pclose assessment and 40 for ApneaLink studies (every third consenting participant will be invited to complete the home sleep assessment).
At the completion of data collection, independent samples t-test (where data is normally distributed) and Wilcoxon signed ranks test (where data is not normally distributed) will be used to identify differences in Pclose between patients who do and do not experience an adverse event. Linear regression will be used to examine the relationship between Pclose and OSA severity as determined by ApneaLink.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/05/2018

Actual

8/05/2018

Date of last participant enrolment

Anticipated

31/12/2019

Actual

Date of last data collection

Anticipated

31/12/2019

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue
Nedlands, WA 6009

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Australian and New Zealand College of Anaesthetists

Address

630 St Kilda Rd
Melbourne, VIC, 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Commitee

Ethics committee address [1]

2nd Floor A Block
Hospital Avenue
Nedlands, WA, 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2017

Approval date [1]

02/03/2018

Ethics approval number [1]

RGS0000000279

Summary

Brief summary

This project is an observational study assessing upper airway collapsibility and peri- and post-operative adverse events in patients undergoing surgery not related to the head, neck, airways or chest. Demographic and anthropometric (height, weight, neck circumference, Mallampati) information will be recorded and a STOP-Bang assessment performed prior to surgery in all consenting patients.  Following surgery, prior to transfer to the recovery room, assessment of airway collapsibility will be performed using the Pclose technique.  In addition, all adverse events including respiratory adverse events (respiratory depression (rate & depth), desaturation events, requirement for re-intubation or other medical intervention including unplanned initiation of positive airway pressure therapy) will be documented as well as length of stay in hospital and planned and unplanned intensive care unit or high dependency unit admissions.  Within 3 weeks of surgery, sleep apnoea severity will be ascertained in a subgroup of consenting participants with a reliable home monitoring device (ApneaLink).

The expected outcome of this research is to demonstrate that Pclose is a suitable method for quickly identifying the presence of abnormal airway collapsibility in surgical patients and that airway collapsibility, as measured by Pclose, is greater in those people who experience post-operative adverse events.  This will then potentially enable high-risk patients to be stratified to the appropriate level of care and improve post-operative patient safety. It is hypothesised that more adverse respiratory events will occur in those patients with the greatest airway collapsibility.    In addition, a measure of airway collapsibility in the early post-operative period may provide a useful tool for identifying patients at high risk of OSA beyond the perioperative period. In those patients, it is hypothesised that airway collapsibility will be greatest in those with the most severe OSA and lowest in those patients without OSA.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/374564-00279 - letter - HREC approval - 01032018.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Jennifer Walsh

Address

Department of Pulmonary Physiology and Sleep Medicine
Sir Charles Gairdner Hospital
Internal Mailbox 201
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+61 8 6457 1070

Fax

jennifer.walsh@health.wa.gov.au

Contact person for public queries

Name

Jennifer Walsh

Address

Department of Pulmonary Physiology and Sleep Medicine
Sir Charles Gairdner Hospital
Internal Mailbox 201
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+61 8 6457 1070

Fax

jennifer.walsh@health.wa.gov.au

Contact person for scientific queries

Name

Jennifer Walsh

Address

Department of Pulmonary Physiology and Sleep Medicine
Sir Charles Gairdner Hospital
Internal Mailbox 201
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+61 8 6457 1070

Fax

jennifer.walsh@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

after de-identification individual participant data underlying published results only

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years following main results publication

Available to whom?

only researchers who provide a methodologically sound proposal

Available for what types of analyses?

only to achieve the aims in the approved proposal

How or where can data be obtained?

access subject to approvals by Principal Investigator

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

No additional documents have been identified.

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