UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019184
Receipt number R000021769
Scientific Title Does High Flow Nasal Cannula placed before extubation with a fraction of inspired oxygen adjusted to a lower level prevent the formation of atelectasis after extubation: A prospective double-blinded randomized controlled trial.
Date of disclosure of the study information 2015/10/01
Last modified on 2020/09/19 12:59:40

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Basic information

Public title

Does High Flow Nasal Cannula placed before extubation with a fraction of inspired oxygen adjusted to a lower level prevent the formation of atelectasis after extubation: A prospective double-blinded randomized controlled trial.

Acronym

HFNC before extubation

Scientific Title

Does High Flow Nasal Cannula placed before extubation with a fraction of inspired oxygen adjusted to a lower level prevent the formation of atelectasis after extubation: A prospective double-blinded randomized controlled trial.

Scientific Title:Acronym

HFNC before extubation

Region

Japan


Condition

Condition

Patients with mechanical ventilation in surgical intensive care unit.

Classification by specialty

Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Study hypothesis
A placement of a High Flow Nasal Cannula before extubation with a fraction of inspired oxygen adjusted to a lower level can reduce the formation of atelectasis after extubation in surgical intensive care unit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Primary Outcome
The degree of atelectasis formation in one, three and five days after endtracheal extubation which are evaluated by blinded radiologists using the radiological atelectasis score.

Key secondary outcomes

Secondary Outcome
The incidence of the re-intubation and the initiation of of non-invasive positive airway ventilation within 5 days after extubation.
Duration of intensive care unit.
PaO2/FiO2 ratio in 15 minutes, 1 hour, 12 hours and 24 hours after extubation.
Degree of SpO2 just after extubation (one to 15 minutes).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

High oxygen concentration Group
High Flow Nasal Cannula is placed just before extubation with a fraction of inspired oxygen of 100% and a current flow of 40L/minute. Patients are manually ventilated with bag using 100% oxygen before extubatioin.

Interventions/Control_2

High Flow Nasal Cannula is placed just before extubation with an adjusted fraction of inspired oxygen and a current flow of 40L/minute. The definition of adjusted oxygen concentration is as follows; PaO2/FiO2 ratio is measured at 15 minutes before extubation, and the value of adjusted oxygen concentration is calculated so that the PaO2 should become 100mmHg. The same fraction of inspired oxygen as the mechanical ventilator is used for manual ventilation with bag.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The adult patients in our surgical intensive care unit who are going to have endtrachal tubes extubated.

Key exclusion criteria

The patients who are not managed by anesthesiologists, those who undergo tracheotomy, those who use non-invasive positive ventilation after extubation and those who cannot use High Flow Nasal Cannula after extubation.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kenzo
Middle name
Last name Ishii

Organization

Fukuyama City Hospital

Division name

Department of Anesthesiology and Oncological Pain Medicine

Zip code

721-8511

Address

5-23-1, Zao-cho, Fukuyama city, Hiroshima, 721-8511 Japan

TEL

084-941-5151

Email

keishii@city.fukuyama.hiroshima.jp


Public contact

Name of contact person

1st name Kenzo
Middle name
Last name Ishii

Organization

Fukuyama City Hospital

Division name

Department of Anesthesiology and Oncological Pain Medicine

Zip code

721-8511

Address

5-23-1, Zao-cho, Fukuyama city, Hiroshima, 721-8511 Japan

TEL

084-941-5151

Homepage URL


Email

keishii@city.fukuyama.hiroshima.jp


Sponsor or person

Institute

Fukuyama City Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuyama city hospital, Ethics Committee

Address

5-23-1, Zao-cho, Fukuyama city, Hiroshima, 721-8511 Japan

Tel

084-941-5151

Email

shimin-byouin@city.fukuyama.hiroshima.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

福山市民病院(広島県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 01 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Unpublished


Result

URL related to results and publications

Unpublished

Number of participants that the trial has enrolled

51

Results

The incidence of atelectasis formation that integrated 3 days data of RAS score (Group A:69.6%, H:81% p=0.38), RAS score of each day, and the rate of atelectasis formation at each day, had no significant difference. However, the P/F ratio measured 1 hour after extubation of Group A was significantly higher than that of Group H (360 vs. 265) in repeated measure ANOVA. The re-intubation ratio of Group A tended to be lower than that of Group H (0% vs. 14.3% p=0.06).

Results date posted

2019 Year 12 Month 03 Day

Results Delayed

Delay expected

Results Delay Reason

Delay of analysis

Date of the first journal publication of results


Baseline Characteristics

Out of the 51 cases with consent, we analyzed 23 cases in Group A(Adjusted Oxygen Group), and 21 cases in Group H(High Oxygen Group).

Participant flow

We enrolled patients with mechanical ventilation for more than 12 hours in our surgical ICU. After deciding to extubate, we allocated patients into the adjusted low oxygen concentration Group (Group A) and high oxygen concentration Group (Group H). We used high flow nasal cannula (HFNC) at extubation. We used the value of FiO2 of Group A, which was calculated from the PaO2/FiO2 ratio measured 15 minutes before extubation. FiO2 of HFNC in Group H was set to 100% until the first analysis of P/F ratio after extubation.

Adverse events

None

Outcome measures

The primary outcome was the incidence of atelectasis formation evaluated based on three chest X-rays taken on Day1, 3 and five after extubation. A radiological physician assessed the atelectasis formation using the radiological atelectasis score (RAS).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2015 Year 09 Month 24 Day

Date of IRB

2015 Year 09 Month 24 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2017 Year 10 Month 07 Day

Date of closure to data entry

2017 Year 11 Month 01 Day

Date trial data considered complete

2017 Year 11 Month 01 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 30 Day

Last modified on

2020 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021769


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name