UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019184
Receipt No. 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 (Ver. 9)

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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
Institute Fukuyama City Hospital
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021769