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Trial registered on ANZCTR


Registration number
ACTRN12625000205437p
Ethics application status
Submitted, not yet approved
Date submitted
21/01/2025
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial to determine whether a continuous monitoring system allows earlier detection of patient deterioration on the ward during recovery after bariatric surgery compared to standard of care 4-hourly vital signs monitoring
Scientific title
Assessment of the Capability of Wearable Respiratory Monitoring (Portrait™ Mobile Monitoring) to Detect Early Signs of Deterioration in a Postoperative Metabolic and Bariatric Surgery Population
Secondary ID [1] 313656 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recovery after bariatric surgery 336228 0
Patient deterioration 336543 0
Condition category
Condition code
Public Health 332767 332767 0 0
Health service research
Surgery 333058 333058 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
While recovering on the ward after bariatric surgery for up to 72 hours, participants are assigned to be monitored by either standard-of-care (SOC) 4-hourly vital signs monitoring by nursing staff, or using Portrait Mobile Monitoring System plus SOC 4-hourly vital signs monitoring. Any patient deterioration that occurs between the SOC 4-hourly vitals monitoring may be missed. Portrait Mobile is a wearable, wireless monitoring system that allows doctors and nurses to monitor vital signs continuously. Alarms based on pre-set criteria alert the medical staff and allow them to detect deterioration in health as it is happening so they can intervene and treat the patient before it gets worse.

The Portrait Mobile monitoring system continuously monitors heart rate, breathing rate and oxygen saturation. Heart rate and oxygen saturation are measured by a sensor worn on the tip of the index finger and secured to a strap around the wrist. Breathing rate is measured by three electrodes attached to the chest using adhesive patches. The three electrodes are connected to each other and to a connector by wires. Then, a sensor and a battery are fitted to the connector.

Portrait Mobile is a continuous monitoring system with patient vitals viewed and stored on a central viewing monitor located at the nurses’ station. Sensors are in situ at all times other than during showering and washing when they will be removed by the nursing staff (electrodes remain in place).
Intervention code [1] 330258 0
Treatment: Devices
Comparator / control treatment
Comparator monitoring protocol is standard-of-care 4-hourly vital signs monitoring according to normal ward procedure.
Control group
Active

Outcomes
Primary outcome [1] 340290 0
Triggered clinical intervention as a result of contemporaneous monitoring of participant deterioration (abnormal RR) detected between the standard of care vital sign monitoring protocols. Based on the Westmead Private Hospital guidelines for respiratory rate monitoring in adults, deterioration is defined as a RR of less than 10 breaths per minute or more than 24 breaths per minute.
Timepoint [1] 340290 0
The Portrait Mobile Nurse/Physician Questionnaire is completed by the nursing staff and physicians on rotation away from the ward or once the final participant has been discharged, ie once their care of participants enrolled in this trial is finished.
Secondary outcome [1] 443635 0
Nurse/physician satisfaction with participant status
Timepoint [1] 443635 0
Questionnaire is completed completed by treating staff on rotation away from the ward or once the final participant has been discharged
Secondary outcome [2] 443636 0
Participant tolerance for the Portrait Mobile monitoring system
Timepoint [2] 443636 0
QoR-15 is completed at 3 timepoints: preoperatively, at 24 hours post-operatively and at discharge. The Portrait Mobile Participant Questionnaire is at discharge from the ward.
Secondary outcome [3] 444550 0
Patient satisfaction with the Portrait Mobile monitoring system
Timepoint [3] 444550 0
The Portrait Mobile Participant Questionnaire is at discharge from the ward.
Secondary outcome [4] 444551 0
Nurse/physician confidence in participant status
Timepoint [4] 444551 0
Questionnaire is completed completed by treating staff on rotation away from the ward or once the final participant has been discharged

Eligibility
Key inclusion criteria
1. Adults at least 18 years of age scheduled for bariatric-metabolic surgery (any of the following):
a. laparoscopic sleeve gastrectomy (LSG)
b. laparoscopic gastric bypass (single anastomosis gastric bypass or Roux-en-Y bypass)
c. revisional bariatric surgery
2. BMI greater than or equal to 35
3. ASA classification greater than or equal to III
4. Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Fitted with an Implantable Minute Ventilation Rate Responsive Pacemaker
2. Any condition which, in the view of the investigator, would preclude the participant from being able to safely participate in the trial or complete the participant questionnaires.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation code will be kept on the ward. Participants arriving on the ward after surgery will be assigned the next sequential participant number, and the nursing unit manager will consult the randomisation schedule to see the assigned monitoring protocol (Portrait Mobile plus SOC vitals, or SOC vitals alone) for that participant number. The randomisation schedule is not visible to the investigators determining eligibility who are located in a different building and will not be granted access to the randomisation code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation without stratification using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The findings of Sun 2015 (Sun, Z., et al. Postoperative hypoxemia is common and persistent: a prospective blinded observational trial. Anesth Analg, 121: 709-15 (2015)) showed that continuous monitoring of a vital sign (in this case pulse oximetry) had an odds ratio (OR) of 11.94, i.e. continuous monitoring was almost 12 times more likely to detect a deterioration compared with standard of care. Based on the numbers in this article (Proportion 1: 308/833=0.37, Proportion 2: 30/594= 0.05) and using a confidence interval of 95%, a power of 90 and a treatment ratio of 2:1, the sample size required is 28 in the Portrait Mobile arm and 56 in the standard of care arm.

The primary outcome (earlier detection of participant deterioration leading to improved patient safety, based on the institutional guidelines for respiratory rate monitoring in adults where deterioration is defined as a RR of less than 10 breaths per minute or more than 24 breaths per minute) will be evaluated by analysis of:
• the Portrait Mobile Nurse/Physician Questionnaire completed by the nursing staff and physicians
• early intervention defined as less than 4 hours elapsed time since the last standard of care vital signs measurements, as indicated by Portrait Mobile monitoring system alarm data and medical record data.

As part of the analysis the investigator will compare the timing of system alarms in the Portrait Mobile arm to entries in the medical records leading up to the alarm, including the pain scores (recorded as 0-6 out of 10 or 7-10 out of 10) in the medical records, to ascertain what might have contributed to the alarm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27454 0
Westmead Private Hospital - Westmead
Recruitment postcode(s) [1] 43566 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 318122 0
Charities/Societies/Foundations
Name [1] 318122 0
Ramsay Hospital Research Foundation
Country [1] 318122 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ramsay Health Care
Address
Country
Australia
Secondary sponsor category [1] 320504 0
None
Name [1] 320504 0
Address [1] 320504 0
Country [1] 320504 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316768 0
Ramsay Health Care Human Research Ethics Committee A
Ethics committee address [1] 316768 0
Ethics committee country [1] 316768 0
Australia
Date submitted for ethics approval [1] 316768 0
27/11/2024
Approval date [1] 316768 0
Ethics approval number [1] 316768 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138954 0
Dr John Leyden
Address 138954 0
Sydney Bariatric Clinic, Westmead Specialist Centre, 9/16-18 Mons Rd, Westmead NSW 2145
Country 138954 0
Australia
Phone 138954 0
+61 417 697912
Fax 138954 0
Email 138954 0
john@neuroendocrine.org.au
Contact person for public queries
Name 138955 0
Samantha Malpass
Address 138955 0
CTRU, Westmead Private Hospital, 12A Mons Road, Westmead NSW 2145
Country 138955 0
Australia
Phone 138955 0
+61 2 8837 9110
Fax 138955 0
Email 138955 0
CTRU.WMP@ramsayhealth.com
Contact person for scientific queries
Name 138956 0
John Leyden
Address 138956 0
Sydney Bariatric Clinic, Westmead Specialist Centre, 9/16-18 Mons Rd, Westmead NSW 2145
Country 138956 0
Australia
Phone 138956 0
+61 2 9687 7019
Fax 138956 0
Email 138956 0
john@neuroendocrine.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.