Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
ACTRN12617001289303
Ethics application status
Approved
Date submitted
26/07/2017
Date registered
6/09/2017
Date last updated
19/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An audit of neuromuscular monitoring and adverse airway outcomes in patients recovering from general anaesthesia.
Scientific title
An audit of neuromuscular monitoring and adverse airway outcomes using the Train of four ratio and count in patients recovering from general anaesthesia.
Secondary ID [1] 292533 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative residual curarisation 304189 0
Condition category
Condition code
Anaesthesiology 303516 303516 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Train of four count ratio (TOFR) and count (TOFC) measured on patients who arrive in Recovery Unit after general anaesthesia requiring muscle relaxant.
TOFR and TOFC will be measured using the GE Neuromuscular monitor (NMT).
TOFR will be performed in patients on arrival in Recovery by a scholarly selective medical student face to face with the patient. The initial TOFR will be measured. If it is less than 90% (0.9) then the TOFR will be measured at 1 minute intervals until the TOFR reaches 90%.
Intervention code [1] 298728 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302892 0
Incidence of post-operative residual curarisation (PORC) in PACU after general anaesthesia requiring muscle relaxant.
Incidence of PORC will be assessed using the TOFR which will be measured with the GE NMT monitor.
Timepoint [1] 302892 0
Every minute from arrival in PACU until discharge from PACU
Secondary outcome [1] 337351 0
Prevalence of neuromuscular monitoring in the operating theatre complex of a tertiary hospital will be assessed by the review of the anaesthetic charts.
This review will be performed by the scholarly selective medical student.
Timepoint [1] 337351 0
From start of anaesthesia induction until patient is transferred to PACU
Secondary outcome [2] 337352 0
Incidence of adverse airway events in PACU
Oxygen saturation less than 92% as seen on pulse oximeter
Need for airway support such as jaw thrust or chin lift in PACU
Need for re-intubation in PACU
Timepoint [2] 337352 0
From arrival in PACU until patient is discharged from PACU
Secondary outcome [3] 338334 0
Time taken for TOFR to reach 0.9 in PACU was measured using the GE NMT monitor
Timepoint [3] 338334 0
Even minute from arrival in PACU until discharge from PACU

Eligibility
Key inclusion criteria
Patients undergoing general anaesthesia requiring muscle relaxant and who will be extubated at the end of the surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who will not be extubated at the end of the case
Patients who do not receive general anaesthesia requiring muscle relaxant

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/02/2017
Date of last participant enrolment
Anticipated
Actual
7/04/2017
Date of last data collection
Anticipated
Actual
7/04/2017
Sample size
Target
200
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8620 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 16728 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 297106 0
University
Name [1] 297106 0
University of Melbourne
Country [1] 297106 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan St
Parkville VICTORIA
3050
Country
Australia
Secondary sponsor category [1] 296116 0
None
Name [1] 296116 0
None
Address [1] 296116 0
None
Country [1] 296116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298283 0
Melbourne Health Office for Research
Ethics committee address [1] 298283 0
Grattan St
Parkville VICTORIA
3050
Ethics committee country [1] 298283 0
Australia
Date submitted for ethics approval [1] 298283 0
25/08/2016
Approval date [1] 298283 0
19/09/2016
Ethics approval number [1] 298283 0
QA2016130

Summary
Brief summary
We aim to determine the incidence of post-operative residual curarisation (PORC) in Peri-anaesthesia care unit (PACU) after general anaesthesia requiring a muscle relaxant. We will also measure the incidence of adverse airway events in PACU and determine if there is an association with PORC.
As this was deemed to be a low risk study, patient consent was not required prior to recruitment. Patients were followed up in PACU after transfer from the operating theatre. Once in PACU, a neuromuscular monitor was placed and the train-of-four ratio (TOFR) was measured. This measurement was performed at 1 minute intervals until TOFR reached 0.9. The time then for TOFR to reach 0.9 was measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76578 0
Dr Juliana Kok
Address 76578 0
Royal Melbourne Hospital
Department of Anaesthesia and Pain Management
Grattan St
Parkville 3050
VICTORIA
Country 76578 0
Australia
Phone 76578 0
+61 3 93427540
Fax 76578 0
Email 76578 0
juliana.kok@mh.org.au
Contact person for public queries
Name 76579 0
Dr Juliana Kok
Address 76579 0
Royal Melbourne Hospital
Department of Anaesthesia and Pain Management
Grattan St
Parkville 3050
VICTORIA
Country 76579 0
Australia
Phone 76579 0
+61 3 93427540
Fax 76579 0
Email 76579 0
juliana.kok@mh.org.au
Contact person for scientific queries
Name 76580 0
Dr Juliana Kok
Address 76580 0
Royal Melbourne Hospital
Department of Anaesthesia and Pain Management
Grattan St
Parkville 3050
VICTORIA
Country 76580 0
Australia
Phone 76580 0
+61 3 93427540
Fax 76580 0
Email 76580 0
juliana.kok@mh.org.au

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
No additional documents have been identified.