Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00644

2 Trial Registration Date

2018-12-12

i Registration Status

Prospective

3 Secondary IDs

Protocol Version 1.1

4 Source(s) of Funding

None

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Charles Gomersall

ii Address

Dept of Anaesthesia & Intensive Care,
Prince of Wales Hospital,
Shatin, Hong Kong

iii Phone

5569 9223

iv Email

gomersall@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Chi Yan Catherine Lung

ii Address

Dept of Anaesthesia & Intensive Care,
Prince of Wales Hospital,
Shatin, Hong Kong

iii Phone

90386866

iv Email

1155089716@link.cuhk.edu.hk

v Affiliation

Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Prospective observational cohort study to assess the ability of mechanically-ventilated patients to press buttons on a smartphone application

10 Public Title

Smartphone use by mechanically-ventilated patients in the ICU

i Public Title in Chinese 研究名稱

N/A

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-11-23

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.407

14 Medical Condition Being Studied

Fine motor function

15 Intervention

i Types of intervention

Other

Please specify

Non-interventional

ii Description/ name of Intervention/article

None

iii Dosage form of the intervention

None

iv Dosage of the intervention

None

v Duration of the intervention

None

vi Frequency of the intervention

None

16 Comparative Treatments

i Description/ name of comparative treatments

None

ii Dosage form of the comparative treatments

None

iii Dosage of the comparative treatments

None

iv Duration of the comparative treatments

None

v Frequency of the comparative treatments

None

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Mechanically-ventilated patients in the intensive care unit

Fully conscious

Grade 4 or above muscle power on MRC scale

Satisfactory visual acuity after correction (determined by the ability to count the number of fingers held up at a distance of 2 feet away)

ii Exclusion Criteria

Delirious

Children or adolescent (of less than 18-year-old)

Illiterates

Mentally incapacitated persons

Patients in emergency conditions

Prisoners

Subordinates or students of investigators

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

Observational

vi Study Objectives (Optional)

20 Anticipated trial start date

2019-01-01

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Accuracy in pressing buttons on a smartphone app

ii The metric or method of measurement used

Frequency of appropriate activation

iii The timepoint(s) of primary interest

Immediate

24 Secondary Outcome

i The Name of the outcome

None

ii The metric or method of measurement used

None

iii The timepoint(s) of primary interest

None

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-12-12

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

Back History

Trial Detail