Trial no.:	PACTR202212474343995	Date of Approval:	12/12/2022
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Feasibility of a Wireless Monitoring System as an Alternative to Current Bedside Monitors Investigators:

Official scientific title

Feasibility of a Wireless Monitoring System as an Alternative to Current Bedside Monitors Investigators:

Brief summary describing the background and objectives of the trial

Background: Current post-operative monitoring practices of patients at Korle-Bu teaching hospital rely on manual blood pressure, temperature and heart rate monitoring which are inefficient, and often miss the onset of complications. Consumer-grade wearables (e.g., Fitbit and Xiaomi band), which collect vital signs similar to clinical-grade monitors and transmit them in near-real time to a smartphone/IPad and then to a cloud-based platform that allows further processing of data, provide an opportunity to implement a wireless monitoring system as an alternative to current bedside monitors. ii. General Aim: To establish the feasibility of a Fitbit/Xiaomi band-based wireless monitoring system for post-operative in-hospital monitoring iii. Methodology: Fifteen (15) inpatient (pediatric appendicitis), and 15 accident centre patients (adult and pediatric trauma) will be recruited at the Korle Bu Teaching Hospital at two sites: the inpatient pediatric surgery wards, and the accident centre. A Fitbit/Xiaomi band will be placed on each inpatient’s wrist on postoperative day 1 and until they are discharged, and on each trauma patient’s wrist while in the accident centre. The Fitbit/Xiaomi band will be linked using Bluetooth technology to an IPad or iPhone, and data will be streamed to the IDataPoint cloud-based platform that will be accessible to the nurse on the IPad or iPhone, and on the surgeon’s phone. Fitbit and Xiaomi band data will be downloaded and compared to manually obtained vitals from the patient medical charts. At the conclusion of the study, all study participants, parents and up to 10 healthcare workers will be invited to participate in a voluntary semi-structured interview to ascertain perspectives from the respective individuals. iv. Expected Outcome At the end of this study, we hope to establish the feasibility of this wireless monitoring system as a means of monitoring patients postoperatively and after trauma and pave the way for further evaluation

Type of trial

CCT

Acronym (If the trial has an acronym then please provide)

FWMS

Disease(s) or condition(s) being studied

Surgery

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Devices

Anticipated trial start date

01/06/2023

Actual trial start date

Anticipated date of last follow up

11/09/2023

Actual Last follow-up date

Anticipated target sample size (number of participants)

40

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification	Allocation was determined by the holder of the sequence who is situated off site	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Application of device	Not Applicable- A device will be worn on the wrist	The Device will be worn till the patient is discharged	Application of a Consumer wearable device to monitor pulse and saturation	40
Control Group	Monitoring of vital signs manually	6 hourly	Till patients are discharged	Monitoring of vital signs manually	40	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
All patients who have had surgery for Appendicitis between the ages of 0 and 13 years All patients admitted to the red section of the accident and emergency unit after trauma	All patients who are unable to wear a wristband due to injury to the wrist or arm or other reason	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year	1 Year(s)	80 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

15/11/2022

Korle bu Teaching Hospital IRB

Ethics Committee Address
Street address	City	Postal code	Country
Guggisberg Avenue	Accra	00233	Ghana

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	The vital signs will be similar to vital signs recorded manually	6 hourly
Secondary Outcome	It will be possible to monitor patients on out-patient basis even when moving around	6 hourly

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Korlebu Teaching hospital Paediatric Surgery Unit and Accident Centre	Guggisberg Avenue	Acccra		Ghana

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Ann and Robert H Lurie Chidrens Hospital and North Western University	225 E Chicago Avenue	Chicago illinois	60611	United States of America

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	North Western University	175 Sam Sibley Dr	Natchitoches Louisiana	7197	United States of America	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Dr Fizan Abdullah	225 East Chicago Avenue, Box 63	Illinois	60611-260	United States of America
Elsie Effah Kaufmann PhD	Legon Boundary	Accra		Ghana
Dr. Henry Bulley	Guggisberg Avenue	Accra	Box 77	Ghana
Hassan Ghomrawi	633 N St Clair, 20th floor	Accra		United States of America
Godfrey A. Mills	Legon Boundary Road	Accra		Ghana
Matthew Glucksberg	2145 Sheridan Road	Illinois		United States of America
Soyang Kwon	680 N Lake Shore Drive	Illinois		United States of America
Dr. J. Benjamin Pitt	225 East Chicago Avenue, Box 63	Illinois	60611-260	United States of America

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	William Appeadu Mensah	wappmens@gmail.com	+233208169432	Guggisberg Avenue
City	Postal code	Country	Position/Affiliation
Accra		Ghana	Senior Lecturer Consultant Paediatric Surgeon
Role	Name	Email	Phone	Street address
Public Enquiries	William Appeadu Mensah	wappmens@gmail.com	+233208169432	No 1 Staff Road
City	Postal code	Country	Position/Affiliation
Accra		Ghana	Consultant Paediatric Surgeon Korle bu
Role	Name	Email	Phone	Street address
Scientific Enquiries	Fizan Abdullah	fizanabdullahmd@gmail.com	+14109797762	225 E Chicago Avenue
City	Postal code	Country	Position/Affiliation
Illinois		United States of America	Professor of Paediatric Surgery

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices) will be reported	Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol	5 years	There will be open access to the data so anyone interested may have access. Anyone may analyse the data in the way he or she wishes.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry