Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00635

2 Trial Registration Date

2018-11-12

i Registration Status

Prospective

3 Secondary IDs

NTEC-2018-0413

4 Source(s) of Funding

The Society of Anesthetists of Hong Kong

5 Primary Sponsor

Tam Suet Yee

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Tam Suet Yee

ii Address

4/F, Main Clinical Block and Trauma Centre
Department of Anesthesiology and Intensive Care Unit
Prince of Whales Hospital
Hong Kong

iii Phone

55699753

iv Email

tsy913@ha.org.hk

v Affiliation

Hospital Authority

vi Country

Hong Kong

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

i Name

Suet Yee Tam

ii Address

4/F, Main Clinical Block and Trauma Centre
Department of Anesthesiology and Intensive Care Unit
Prince of Whales Hospital
Hong Kong

iii Phone

98532824

iv Email

tamsuetyee@gmail.com

v Affiliation

Department of Anesthesia & Intensive Care Unit, Prince of Whales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Intraoperative Use of Non-invasive Cardiac Output Monitoring versus Standard Fluid Management in Free Perforator Flap Surgery: A Randomized Pilot Trial

10 Public Title

Intraoperative Use of Non-invasive Cardiac Output Monitoring versus Standard Fluid Management in Free Perforator Flap Surgery: A Randomized Pilot Trial

i Public Title in Chinese 研究名稱

在游離穿支皮瓣手術期間，比較使用非侵入連續式心臟血液動力參數量測儀與傳統輸液方法之有益效果

11 Short Title (Optional)

Intraoperative Use of Non-invasive Cardiac Output Monitoring in Free Perforator Flap Surgery

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-10-25

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.405-T

14 Medical Condition Being Studied

Head and Neck Cancer

Undergoing Free Perforator Flap Surgery

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

FloTrac System (Edwards Lifesciences, Irvine, CA, USA); which is an non-invasive cardiac output monitoring device to estimate the patient cardiac and hemodynamic parameters during operation.

iii Dosage form of the intervention

Use the Floatrac system to guide intraoperative fluid management versus clinical based

iv Dosage of the intervention

N/A

v Duration of the intervention

Intraoperatively

vi Frequency of the intervention

Once

16 Comparative Treatments

i Description/ name of comparative treatments

Clinical parameters including non-invasive blood pressure monitoring, heart rate, urine output

ii Dosage form of the comparative treatments

Fluid management

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

Intraoperatively

v Frequency of the comparative treatments

Once

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

>18 year-old

Head and neck cancer required surgical excision and free perforator flap surgery

ii Exclusion Criteria

< 18 year-old

Pregnant

Severe psychiatric illnesses

Emergent operation

Re-operation

Patient’s refusal

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Prospective Randomized Control Pilot Study

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

2

Please specify

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

Day at home 30

ii The metric or method of measurement used

From clinical records

iii The timepoint(s) of primary interest

30 days post-operatively

24 Secondary Outcome

i The Name of the outcome

Non-surgical complications ( respiratory complications, acute kidney injury)

ii The metric or method of measurement used

From clinical records

iii The timepoint(s) of primary interest

During first week post-operatively

Secondary Outcome

i The Name of the outcome

Length of stay in hospital

ii The metric or method of measurement used

From clinical records

iii The timepoint(s) of primary interest

Before discharge

Secondary Outcome

i The Name of the outcome

Rate of re-operation

ii The metric or method of measurement used

From clinical records

iii The timepoint(s) of primary interest

On discharge

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-01-29

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-11-12