UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016572
Receipt number R000019231
Scientific Title High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation; A randomized crossover study
Date of disclosure of the study information 2015/02/18
Last modified on 2022/03/07 14:05:41

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Basic information

Public title

High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation; A randomized crossover study

Acronym

High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation

Scientific Title

High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation; A randomized crossover study

Scientific Title:Acronym

High flow nasal cannula versus venturi mask for cardiovascular surgical patients after endotracheal extubation

Region

Japan


Condition

Condition

Patients who underwent cardiovascular surgery

Classification by specialty

Anesthesiology Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate efficacy of high flow nasal cannula for cardiovascular surgical patients after extubation compared with venturi mask.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Arterial blood gas analysis(PaO2,PaCO2,pH,HCO3-)

Key secondary outcomes

Physiologic date(respiratory rate, heart rate, blood pressure, cardiac index, mixed venous oxygen saturation)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Protocol A
venturi mask for 30 minutes, venturi mask for one hour,high flow nasal cannula for one hour

Interventions/Control_2

Protocol B
venturi mask for 30 minutes,high flow nasal cannula for one hour,venturi mask for one hour

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients scheduled cardiovascular surgery (valvuar surgery and coronary artery bypass grafting with median sternotomy using cardiopulmonary bypass)

Key exclusion criteria

Patients who has obstructive lung disease and chronic renal failure.
Patients who requires more than 24 hours until extubation.
Emergent surgery

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Umegaki

Organization

Osaka medical college

Division name

Department of intensive care unit

Zip code

5698686

Address

2-7 Daigaku-machi, Takatsuki, Osaka

TEL

+81-72-683-1221

Email

swithp2006@yahoo.co.jp


Public contact

Name of contact person

1st name Shiho
Middle name
Last name Deguchi

Organization

Osaka medical college

Division name

Department of intensive care unit

Zip code

5698686

Address

2-7 Daigaku-machi, Takatsuki, Osaka

TEL

+81-72-683-1221

Homepage URL


Email

swithp2006@yahoo.co.jp


Sponsor or person

Institute

Department of intensive care unit
Osaka medical college

Institute

Department

Personal name



Funding Source

Organization

Department of intensive care unit
Osaka medical college

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of intensive care unit Osaka medical college

Address

2-7 Daigaku-machi, Takatsuki, Osaka

Tel

072-683-1221

Email

rinri@art.osaka-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 18 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019231

Publication of results

Unpublished


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019231

Number of participants that the trial has enrolled

40

Results

35 patients were enrolled, and 5 patients were excluded from analysis in accordance with the exit criteria. PFR was significantly higher in the HFNC group than in the VM group [265.9 (81.4) vs. 238.7 (68.5), p=0.002]. PaCO2 was significantly lower in the HFNC group than in the VM group [33.8 (3.5) vs. 34.7 (2.9), p=0.033]. The respiratory rate was significantly lower in the HFNC group than in the VM group [18 (4) vs. 21 (4), p=0.006], and no significant differences were seen in any of the other parameters.

Results date posted

2022 Year 03 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Forty patients who underwent cardiovascular surgery

Participant flow

40 patients who underwent cardiovascular surgery in 2015 were randomized to either protocol A (HFNC followed by VM) or protocol B (VM followed by HFNC). After 60-minutes of use with either device, arterial blood gas analysis was performed, and the PaO2/FiO2 ratio (PFR) was calculated. Simultaneously, physiological data (respiratory rate, heart rate, mean arterial pressure, continuous cardiac index, and mixed venous oxygen saturation) were recorded. During this procedure, FiO2 and gas flow were maintained at a fixed rate. These variables were compared by using the paired t-test, and a p value < 0.05 was considered significant. All data were expressed as mean (standard deviation).

Adverse events

Nothing

Outcome measures

blood gas analysis (PaO2/FiO2 ratio (PFR) ,PaCO2, HCO3-, pH)
physiological data (respiratory rate, heart rate, mean arterial pressure, continuous cardiac index, and mixed venous oxygen saturation)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2014 Year 12 Month 01 Day

Date of IRB

2014 Year 12 Month 16 Day

Anticipated trial start date

2014 Year 12 Month 16 Day

Last follow-up date

2016 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 18 Day

Last modified on

2022 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019231


Research Plan
Registered date File name
2022/03/07 NHFvsVM倫理審査申請書②.doc

Research case data specifications
Registered date File name
2022/03/07 NHFvsVM説明書②.docx

Research case data
Registered date File name
2022/03/05 UMIN登録用患者背景(日本語).docx